Radiology AI Directory

FDA-cleared profile

SIGNA Premier

GE Healthcare (GE Medical Systems, LLC)

Authorized purpose: SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option intended to improve signal-to-noise ratio and image sharpness and enable shorter acquisitions while preserving those properties, with images and spectra interpreted by a trained physician.

MRI workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option intended to improve signal-to-noise ratio and image sharpness and enable shorter acquisitions while preserving those properties, with images and spectra interpreted by a trained physician.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option intended to improve signal-to-noise ratio and image sharpness and enable shorter acquisitions while preserving those properties, with images and spectra interpreted by a trained physician.

Evidence takeaway

Evidence from the reviewed source record: Exact-submission FDA evidence includes manufacturer phantom, digital-object, in vivo, and blinded-reader testing, but public counts and patient outcomes are absent. A later 54-examination SIGNA Premier pediatric knee study found AIR Recon DL could materially change quantitative diffusion metrics at higher spatial resolution, and an independent 7,346-examination outpatient study found the AIR Recon DL group achieved up to a 27% scan-time reduction without a significant room-time reduction. These later studies are product-family evidence and do not establish exact K193282 performance at a new site.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option intended to improve signal-to-noise ratio and image sharpness and enable shorter acquisitions while preserving those properties, with images and spectra interpreted by a trained physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Trained physicians for interpretation of the images and/or spectra.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication identifies the trained physician as the interpreter; it does not establish the dossier's trained-imaging-personnel acquisition role.

Care setting and population
Professional MRI facilities equipped for a fixed 3.0T whole-body scanner, MR safety controls, patient screening, protocol governance, image interpretation, and ongoing service and quality assurance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-02
Workflow role
AIR Recon DL operates in the scanner reconstruction pipeline after raw MRI acquisition. A user can enable the option and select a noise-reduction level to improve reconstructed signal-to-noise ratio and sharpness or support a locally validated shorter acquisition.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-02
Required input
MRI acquisitions using compatible RF receive coils and various pulse sequences, imaging techniques, and reconstruction algorithms on the SIGNA Premier system.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description supports these system inputs and capabilities but does not state the dossier's raw-data wording.

Output and human action
Axial, sagittal, coronal, and oblique images; spectroscopic images, parametric maps and/or spectra; and dynamic images of structures and/or functions of the entire body, with AIR Recon DL improving signal-to-noise ratio and image sharpness.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication and device description state these image/spectra outputs and AIR Recon DL image-quality changes; DICOM and the dossier's full output list are not retained.

Limitations
The images and/or spectra yield information that may assist in diagnosis when interpreted by a trained physician; depending on the region of interest, contrast agents may be used.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This replacement uses the exact indication's interpretation and contrast-agent boundaries rather than unsupported universal-performance and patient-outcome claims.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K193282
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-04-10
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
AIR Recon DL is embedded in SIGNA Premier reconstruction rather than applied as a separate DICOM post-processing service. The FDA summary describes SIGNA Premier as DICOM conformant, and GE publishes software-specific conformance statements including RX28.0 for the product family.
  • Public source
  • Product family
  • Checked 2026-09-02

Obtain the conformance statement for the installed build and test worklist, patient demographics, series descriptions, reconstruction metadata, image and presentation-state transfer, routing, failure recovery, and archive behavior end to end.

Deployment and data flow
Fixed on-premises 3.0T whole-body MRI system with a 70 cm bore. K193282 reports no hardware change from the K183231 predicate; AIR Recon DL is enabled within the scanner reconstruction environment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-02

A site still needs scanner-room planning, shielding and power review, MR safety zoning, coil and protocol configuration, PACS and RIS integration, acceptance testing, service coverage, and downtime procedures.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact product version
  • Checked 2026-09-02

No exact K193282-era cybersecurity architecture, MDS2, supported operating-system inventory, patch policy, remote-service controls, audit specification, or vulnerability-management document was established from the reviewed public sources.

Training and support
The FDA-cleared workflow requires trained personnel and trained-physician interpretation. GE separately offers a 3.5-day classroom and lab course for biomedical engineers servicing SIGNA Premier systems; this is service training, not evidence of the clinical-user training package supplied with K193282 or of AIR Recon DL protocol competency.
  • Public source
  • Product family
  • Checked 2026-09-02

Require role-specific operator, radiologist, physicist, MR safety, service, protocol-approval, artifact-recognition, fallback, and change-control training and document competency before clinical use.

Monitoring and change control
Not established in reviewed sources
  • Reviewed sources checked
  • Exact product version
  • Checked 2026-09-02

No public exact-version operational-monitoring specification was established. A local program should track protocol and denoising settings, quantitative-measurement drift, image-quality and artifact complaints, repeats and aborted scans, scan and room time separately, DICOM failures, downtime, service actions, software versions, and open recall corrections.

AIR Recon DL reconstruction controls

A user can enable AIR Recon DL in the SIGNA Premier reconstruction workflow and select a noise-reduction level to improve signal-to-noise ratio and sharpness or support a shorter locally validated acquisition.

exact submission · checked 2026-09-02

Validate every clinical sequence, anatomy, coil, acceleration factor, reconstruction level, artifact pattern, quantitative output, and fallback with radiologist and physicist approval.

Source

Embedded reconstruction deployment

AIR Recon DL processes raw MRI data in the scanner reconstruction pipeline; K193282 reports no hardware change from the K183231 SIGNA Premier predicate.

exact submission · checked 2026-09-02

Confirm installed software and licenses, reconstruction latency, storage and routing effects, rollback, vendor service access, and behavior during partial failure or downtime.

Source

DICOM connectivity

FDA describes the system as DICOM conformant, and GE publishes software-specific SIGNA Premier conformance statements including RX28.0.

product family · checked 2026-09-02

A conformance statement is a planning input, not proof of interoperability. Execute interface, routing, metadata, display, storage-commitment, and recovery tests against each local system.

SourceSource

Throughput measurement

A 7,346-examination outpatient study found up to a 27% scan-time reduction in the AIR Recon DL group but no significant room-time reduction, so business cases should measure both scanner acquisition time and total room occupancy by examination type.

product family · checked 2026-09-02

Model local benefits using case mix, protocol eligibility, setup and turnover time, staffing, operating hours, demand, payer mix, repeat rates, and whether saved minutes can produce additional completed examinations.

Source

Current product-family context

GE continues to market SIGNA Premier as a 3T wide-bore platform and currently presents AIR Recon DL within the family, but later hardware, software, and feature claims may not apply to the K193282 configuration.

product family · checked 2026-09-02

Require a configuration matrix connecting each quoted feature and service commitment to the exact scanner serial number, software build, license, and FDA clearance.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
Exact-submission FDA evidence includes manufacturer phantom, digital-object, in vivo, and blinded-reader testing, but public counts and patient outcomes are absent. A later 54-examination SIGNA Premier pediatric knee study found AIR Recon DL could materially change quantitative diffusion metrics at higher spatial resolution, and an independent 7,346-examination outpatient study found the AIR Recon DL group achieved up to a 27% scan-time reduction without a significant room-time reduction. These later studies are product-family evidence and do not establish exact K193282 performance at a new site.
  • Public source
  • Product family
  • Checked 2026-09-02
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Maximum AIR Recon DL group scan-time reduction

27 % maximum reduction among evaluated examination types

  • EndpointChange in scan time for the k-space-based reconstruction group after clinical implementation relative to the comparison periods
  • Population7,346 outpatient brain, spine, shoulder, knee, and pelvis MRI examinations across 10 clinical 1.5T scanners; two scanners used AIR Recon DL
  • Tested versionCommercial AIR Recon DL on two 1.5T scanners; scanner models and software versions not reported in the abstract
Source

K193282 AIR Recon DL nonclinical and in vivo performance testing

  • DesignManufacturer digital-reference-object and phantom testing plus in vivo objective measures and blinded radiologist reader evaluation
  • PopulationMultiple pulse sequences and anatomies with examples spanning contrast use and pathology; public sample, reader, and site counts not reported
  • Scopeexact submission
  • Tested versionSIGNA Premier with AIR Recon DL cleared in K193282
  • IndependenceSponsor or vendor study

K193282

FDA reports passing nonclinical testing, equivalent or better image legibility, maintained lesion conspicuity, and reader preference, but the public summary does not provide detailed counts, confidence intervals, diagnostic-accuracy endpoints, or patient outcomes.

Source

Impact of Deep Learning Denoising Algorithm on Diffusion Tensor Imaging of the Growth Plate on Different Spatial Resolutions

  • DesignProspective single-center comparison of AIR Recon DL and non-denoised reconstructions from two left-knee diffusion-tensor imaging acquisitions per participant
  • Population54 pediatric left-knee examinations acquired at 3T on a GE SIGNA Premier using 2 mm isotropic and 2 x 2 x 3 mm voxel dimensions
  • Scopeproduct family
  • Tested versionCommercial AIR Recon DL at 75% noise reduction on SIGNA Premier; software release not reported
  • Samplen=54
  • Sites1
  • IndependenceSponsor or vendor study

PMID 38668397

Three coauthors were GE employees. At 2 mm isotropic resolution, DL reconstruction significantly changed tract count, volume, length, and fractional anisotropy, supporting local validation before quantitative DTI measurements are substituted or trended.

Source

Impact of Deep Learning Image Reconstruction Methods on MRI Throughput

  • DesignIndependent retrospective pre- and postimplementation comparison across a large multicenter outpatient MRI practice
  • Population7,346 outpatient brain, spine, shoulder, knee, and pelvis MRI examinations across 10 clinical 1.5T scanners; two scanners used AIR Recon DL, three used a DICOM-based method, and five were nonaugmented
  • Scopeproduct family
  • Tested versionCommercial AIR Recon DL on two 1.5T scanners; scanner models and software versions not reported
  • Samplen=7346
  • IndependenceIndependent study

PMID 38506618

AIR Recon DL was associated with up to a 27% scan-time reduction for evaluated examination types but no significant room-time reduction. Results were heterogeneous by examination type, and image quality was not directly measured in this operational study.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
No public purchase price for the K193282 SIGNA Premier system or AIR Recon DL option was found. GE lists a separate 3.5-day advanced SIGNA Premier service course at $15,500 tuition only, $16,100 with lodging, or $17,600 with lodging and airfare; these amounts are implementation-cost benchmarks, not scanner, software, maintenance, or clinical-training prices.
  • Public source
  • Product family
  • Checked 2026-09-02
Reimbursement and coding
CMS NCD 220.2 addresses coverage of medically necessary MRI and MRA services performed on FDA-authorized equipment within its labeling; it does not establish a separate payment for SIGNA Premier or AIR Recon DL. Coverage, coding, payment, and prior-authorization analysis remains examination-, payer-, site-, and patient-specific.
  • Public source
  • Not applicable
  • Checked 2026-09-02

USD 15500

one-student, 3.5-day advanced service-training course; tuition-only through tuition, lodging, and airfare options · United States

Observed 2026-09-02

Public GE service-training list prices for biomedical engineers. This is not a scanner price, AIR Recon DL license price, implementation quote, clinical-user course, maintenance agreement, or total-cost estimate.

Source

No product-specific code

No separate named-product payment identified in CMS NCD 220.2

Medicare · United States · Effective 2018-04-10

The NCD provides MRI and MRA coverage context and does not assign payment to AIR Recon DL. Verify the ordered examination, medical necessity, current code set, site of service, payer contract, and local coverage rules.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
FDA recall Z-1767-2026 includes SIGNA Premier systems that may contain ferrous steel fittings at the rear of the magnet instead of non-ferrous brass fittings, creating a personnel-injury risk if the rear is serviced while the magnet is ramped. FDA lists the recall as open and classified. FDA recall Z-2304-2025 includes SIGNA Premier systems for which planned maintenance may not have checked patient-table caster-lock function, allowing an undocked table to move during patient transfer. FDA lists the recall as open and classified. FDA recall Z-2462-2024 includes SIGNA Premier software RX27.0-RX27.3, RX28.0, RX29.0-RX29.2, MR30.0, and MR30.1. Under specified Low SAR and 2D T2 FLAIR settings, predicted B1+RMS can exceed the prescribed limit and overheat an MR-conditional implant. FDA lists the recall as open and classified. FDA recall Z-1430-2022 affects SIGNA Premier model 5748519 because rare gradient-coil conditions could produce elevated acoustic noise and prolonged exposure could lead to hearing loss. FDA lists the recall as open and classified. FDA recall Z-0590-2022 includes the superconducting magnet used in SIGNA Premier systems because the cryogen ventilation system may not meet venting requirements. FDA lists the recall as open and classified. FDA recall Z-0132-2022 affected SIGNA Premier because some slices could be missing under certain conditions, creating a gap in anatomy in three-dimensional volume images. FDA lists the recall as terminated. FDA recall Z-2052-2021 affected SIGNA Premier because a user intending to select Save RX could inadvertently select Patient Orientation before the initial three-plane localizer, potentially producing incorrectly annotated or flipped images. FDA lists the recall as open and classified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

recall: Z-1767-2026

Open, Classified

2026-04-02

Native K193282 and SIGNA Premier match. This is a system hardware and service-access issue, not an AIR Recon DL algorithm defect; verify affected-unit and correction status with GE before rear-magnet service.

Source

recall: Z-2304-2025

Open, Classified

2025-08-13

Native K193282 and SIGNA Premier match. This is a patient-table maintenance issue, not an AIR Recon DL defect; verify caster locks before transfer and confirm GE inspection or correction status.

Source

recall: Z-2462-2024

Open, Classified

2024-08-02

Native K193282 and SIGNA Premier match, but the clearance summary does not establish the installed software build. This is an MR sequence and safety-control issue rather than evidence of an AIR Recon DL defect; verify software, optimized-FLAIR configuration, workaround, and correction status.

Source

recall: Z-1430-2022

Open, Classified

2022-06-24

Native K193282 and exact SIGNA Premier model match. This is a gradient-coil acoustic-safety issue, not an AIR Recon DL algorithm defect; verify affected-unit status, the operator-manual addendum, and use of hearing protection rated at least 33 dB NRR.

Source

recall: Z-0590-2022

Open, Classified

2021-12-23

Native K193282 and SIGNA Premier component match. This is a facility, magnet, and quench-safety issue, not an AIR Recon DL defect; verify ventilation inspection, evacuation procedures, and correction status.

Source

recall: Z-0132-2022

Terminated

2021-10-16

Native K193282 and SIGNA Premier match. This is a reconstructed-volume completeness issue; the FDA record does not identify AIR Recon DL as the cause. Confirm the correction is installed and preserve image-completeness review controls.

Source

recall: Z-2052-2021

Open, Classified

2021-07-12

Native K193282 and SIGNA Premier match. This is a user-interface and acquisition-workflow issue, not an AIR Recon DL algorithm-performance finding; verify actual versus prescribed orientation before scanning and confirm correction status.

Source

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
25Fields reviewed
14Source classes checked
12Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 12 PubMed and 6 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 12 PubMed and 6 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 7 FDA recall candidates were manually reviewed: 7 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 7 postmarket candidate records; 7 have been reviewed (7 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, peer reviewed publication, trial registry, vendor product page, vendor interoperability, vendor pricing observation, reimbursement policy, fda device recall, fda decision summary packet, literature index, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K193282: SIGNA Premier

    U.S. Food and Drug Administration - Published 2020-04-10 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-1767-2026: SIGNA Premier systems

    U.S. Food and Drug Administration - Published 2026-04-02 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. FDA recall Z-2304-2025: GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System

    U.S. Food and Drug Administration - Published 2025-08-13 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  5. FDA recall Z-2462-2024: SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    U.S. Food and Drug Administration - Published 2024-08-02 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  6. FDA recall Z-1430-2022: SIGNA Premier magnetic resonance scanner, model 5748519.

    U.S. Food and Drug Administration - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  7. FDA recall Z-0590-2022: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.

    U.S. Food and Drug Administration - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  8. FDA recall Z-0132-2022: SIGNA Premier nuclear magnetic resonance imaging system

    U.S. Food and Drug Administration - Published 2021-10-16 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  9. FDA recall Z-2052-2021: SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

    U.S. Food and Drug Administration - Published 2021-07-12 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  10. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  11. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  12. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  13. SIGNA Premier 3T wide-bore scanner

    GE HealthCare - Accessed 2026-09-02

    Scope: productFamily, implementationCapabilities, currentCommercialContext

  14. SIGNA Premier, Architect, Pioneer, and HD RX28.0 DICOM conformance statement

    GE HealthCare - Accessed 2026-09-02

    Scope: integration, implementationCapabilities, softwareVersion

  15. MR Advanced 3.0T SIGNA Premier Service Training

    GE HealthCare - Accessed 2026-09-02

    Scope: training, pricing, economicsObservation, implementationCapabilities

  16. Impact of Deep Learning Denoising Algorithm on Diffusion Tensor Imaging of the Growth Plate on Different Spatial Resolutions

    Tomography - Published 2024-04-02 - Accessed 2026-09-02

    Scope: evidenceSummary, evidenceStudy, evidenceMetrics

  17. Impact of Deep Learning Image Reconstruction Methods on MRI Throughput

    Radiology: Artificial Intelligence - Published 2024-03-20 - Accessed 2026-09-02

    Scope: evidenceSummary, evidenceStudy, evidenceMetrics, economicsObservation, implementationCapabilities

  18. National Coverage Determination 220.2: Magnetic Resonance Imaging

    Centers for Medicare & Medicaid Services - Published 2018-04-10 - Accessed 2026-09-02

    Scope: reimbursement, mriCoverageContext

Research history

  1. K193282 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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