SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies. K183231 adds AIRx, a deep-learning pre-scan feature that automates and standardizes connected brain-examination prescription and setup steps; the resulting images and spectra remain subject to interpretation by a trained physician.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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. K183231 adds AIRx, a deep-learning pre-scan feature that automates and standardizes connected brain-examination prescription and setup steps; the resulting images and spectra remain subject to interpretation by a trained physician.
FDA source Exact FDA submission Checked 2026-09-02
MRI examinations are acquired by trained imaging personnel, and the generated images and spectra are interpreted by a trained physician. AIRx supports brain-examination prescription but does not replace physician interpretation.
FDA source Exact FDA submission Checked 2026-09-02
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
AIRx operates before image acquisition in brain MRI workflow, using deep learning to automate and standardize connected examination prescription and setup steps. The wider SIGNA Premier platform then acquires and reconstructs the prescribed examination for physician review.
FDA source Exact FDA submission Checked 2026-09-02
Patient and examination setup information plus SIGNA Premier pre-scan or localizer data used to prescribe a brain MRI examination; the scanner also receives the selected pulse sequences, coils, and acquisition parameters for the broader MRI study.
FDA source Exact FDA submission Checked 2026-09-02
An automated, standardized brain-examination prescription for technologist review and subsequent acquisition, followed by DICOM-conformant axial, sagittal, coronal, oblique, dynamic, spectroscopic, or parametric MRI outputs as applicable to the ordered examination.
FDA source Exact FDA submission Checked 2026-09-02
AIRx addresses brain-examination prescription and setup, not autonomous diagnosis. The FDA summary reports manufacturer testing and internal scans but does not provide a patient sample size, an independent comparator study, diagnostic-accuracy endpoints, patient outcomes, or proof that automated prescription is appropriate for every anatomy, protocol, patient, coil, or local workflow.
FDA source Exact FDA submission Checked 2026-09-02
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
K183231
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The FDA summary describes SIGNA Premier as DICOM conformant. GE publishes software-specific DICOM conformance statements for the SIGNA Premier family, including RX27.0, but interoperability still depends on the installed software, configured services, PACS and RIS endpoints, and local validation.
Public source Product family Checked 2026-09-02
Obtain the conformance statement for the installed software build and test worklist, patient demographics, image and presentation-state transfer, routing, failure recovery, and archive behavior end to end.
Fixed on-premises 3.0T whole-body MRI system with a 70 cm bore. AIRx is embedded in the SIGNA Premier acquisition workflow rather than deployed as a separate cloud triage or diagnostic service.
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.
Reviewed sources checked Exact product version Checked 2026-09-02
No exact K183231-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 K183231.
Public source Product family Checked 2026-09-02
Require role-specific operator, radiologist, physicist, MR safety, service, protocol-approval, and fallback training and document competency before clinical use.
Reviewed sources checked Exact product version Checked 2026-09-02
No public exact-version operational-monitoring specification was established. A local program should track AIRx prescription overrides and errors, repeat and aborted scans, protocol drift, image-quality complaints, DICOM failures, downtime, service actions, hearing-protection and MR safety controls, software versions, and open recall corrections.
AIRx brain prescription
AIRx automates and standardizes connected pre-scan steps used to prescribe and set up brain MRI examinations on SIGNA Premier.
exact submission · checked 2026-09-02
Validate landmarking, plane prescription, edge cases, technologist review, manual override, fallback, and protocol-change controls across the local brain protocol catalog.
The cleared system is a superconducting 3.0T whole-body scanner with a 70 cm bore and supports multiplanar, dynamic, parametric, and spectroscopic outputs across multiple anatomies.
exact submission · checked 2026-09-02
Map purchased coils, pulse sequences, accessories, software options, and applications to the installed configuration; the clearance does not establish that every option is licensed at every site.
FDA describes the system as DICOM conformant, and GE publishes software-specific SIGNA Premier conformance statements including RX27.0.
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.
GE continues to market SIGNA Premier as a 3T wide-bore platform and currently presents AIRx and AIR Recon DL within the family, but later hardware, software, and feature claims may not apply to the K183231 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.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Exact-submission evidence is limited to manufacturer verification, validation, simulated-use testing, and internal scans summarized by FDA. The review did not identify an independent peer-reviewed study or registered trial that could be confidently mapped to the K183231 AIRx implementation.
FDA source Exact FDA submission Checked 2026-09-02
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.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K183231 AIRx manufacturer verification and validation
Manufacturer nonclinical verification and validation with risk management, design review, system integration, performance, simulated-use testing, and internal scans · SIGNA Premier engineering and simulated-use tests plus internal brain MRI scans used to assess prescription productivity and consistency; public sample size not reported
exact submission · Tested version: SIGNA Premier with AIRx cleared in K183231 · Sponsor or vendor study
K183231
The public FDA summary reports that testing passed but does not provide a reader count, independent clinical site, diagnostic-accuracy endpoint, confidence interval, or patient-outcomes analysis.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
No public purchase price for the K183231 SIGNA Premier system or AIRx 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.
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, AIRx, or automated brain prescription. Coverage, coding, payment, and prior-authorization analysis remains examination-, payer-, site-, and patient-specific.
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, AIRx license price, implementation quote, clinical-user course, maintenance agreement, or total-cost estimate.
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 AIRx. Verify the ordered examination, medical necessity, current code set, site of service, payer contract, and local coverage rules.
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.
Native K183231 and SIGNA Premier match. This is a system hardware and service-access issue, not an AIRx algorithm defect; verify affected-unit and correction status with GE before rear-magnet service.
Native K183231 and SIGNA Premier match. This is a patient-table maintenance issue, not an AIRx defect; verify caster locks before transfer and confirm GE inspection or correction status.
Native K183231 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 AIRx defect; verify software, optimized-FLAIR configuration, workaround, and correction status.
Native K183231 and exact SIGNA Premier model match. This is a gradient-coil acoustic-safety issue, not an AIRx algorithm defect; verify affected-unit status, the operator-manual addendum, and use of hearing protection rated at least 33 dB NRR.
Native K183231 and SIGNA Premier component match. This is a facility, magnet, and quench-safety issue, not an AIRx defect; verify ventilation inspection, evacuation procedures, and correction status.
Native K183231 and SIGNA Premier match. This is a reconstructed-volume completeness issue; the FDA record does not identify AIRx as the cause. Confirm the correction is installed and preserve image-completeness review controls.
Native K183231 and SIGNA Premier match. This is a user-interface and acquisition-workflow issue, not an AIRx algorithm-performance finding; verify actual versus prescribed orientation before scanning and confirm correction status.
Verify security and privacy controls: No exact K183231-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.
Verify local validation and lifecycle monitoring: No public exact-version operational-monitoring specification was established. A local program should track AIRx prescription overrides and errors, repeat and aborted scans, protocol drift, image-quality complaints, DICOM failures, downtime, service actions, hearing-protection and MR safety controls, software versions, and open recall corrections.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-04Last searched
22Fields reviewed
12Source classes checked
11Unreviewed PubMed leads
6Unreviewed trial leads
0Unreviewed FDA recall leads
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. The exact FDA summary, current product-family page, RX27 DICOM statement, public service-training price, CMS MRI coverage policy, PubMed and ClinicalTrials.gov candidates, and all seven exact-identifier FDA recall candidates were manually reviewed. The literature and trial candidates did not establish an independent study of the exact K183231 AIRx implementation. Cybersecurity and exact-version monitoring remain explicit unknowns rather than inferred from later product-family materials. Automated exact-name discovery found 11 PubMed and 6 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 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 remain unpublished until a human confirms the exact product and tested version.
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, pubmed, clinical trials, openfda device recall
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