Radiology AI Directory

FDA-cleared profile

Sonic DL

GE Medical Systems,LLC (GE Healthcare)

Sonic DL is deep-learning MRI reconstruction for highly undersampled or accelerated cardiac acquisitions on compatible GE 1.5T and 3.0T MRI systems for pediatric and adult patients.

Cardiac imaging
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

Sonic DL is deep-learning MRI reconstruction for highly undersampled or accelerated cardiac acquisitions on compatible GE 1.5T and 3.0T MRI systems for pediatric and adult patients.

Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.

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
Sonic DL is deep-learning MRI reconstruction for highly undersampled or accelerated cardiac acquisitions on compatible GE 1.5T and 3.0T MRI systems for pediatric and adult patients.
  • 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.

Intended users
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-19

Previous value withdrawn: The exact FDA decision-summary packet reviewed on 2026-09-19 does not establish this claim.

Care setting and population
Hospital and outpatient MRI departments using compatible scanner models and release-specific sequences.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Integrated MR reconstruction that accelerates acquisition or changes image appearance before routine professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Data from MR cardiac cine exams obtained using a highly accelerated acquisition technique.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states the source and type of data to which the reconstruction algorithm is applied.

Output and human action
MR images reconstructed from highly under-sampled data, enabling highly accelerated acquisitions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indications for use state the reconstruction output and acceleration purpose without adding unsupported export or archival claims.

Limitations
Available for use on GE Healthcare 1.5T and 3.0T MR systems; intended for cardiac imaging and patients of all ages.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indications for use define the supported field strengths, cardiac scope, and patient age scope.

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
K223523
  • 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
Heart/Cardiovascular
  • 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
2023-05-30
  • 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
Integrated scanner reconstruction followed by normal DICOM delivery; validate reconstruction labels, geometry, quantitative values, PACS display, and downstream compatibility.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223523; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Licensed reconstruction software integrated into the specified MRI scanner configurations.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223523; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified mri technologists and interpreting physicians should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Performance depends on scanner, field strength, coil, sequence, anatomy, acceleration, input quality, and reconstruction setting; reconstructed images remain subject to physician review.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K223523; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K223523 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Integrated scanner reconstruction followed by normal DICOM delivery; validate reconstruction labels, geometry, quantitative values, PACS display, and downstream compatibility.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Performance depends on scanner, field strength, coil, sequence, anatomy, acceleration, input quality, and reconstruction setting; reconstructed images remain subject to physician review.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Performance depends on scanner, field strength, coil, sequence, anatomy, acceleration, input quality, and reconstruction setting; reconstructed images remain subject to physician review.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

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
K223523 reports 57 unique subjects, 107 image series from seven sites, and reader studies involving three radiologists, including cardiac pathology and healthy-volunteer image-quality comparisons. The public FDA summary supports the tested accelerated cardiac MR workflow but does not provide a single general sensitivity or specificity claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Unique validation subjects

57 subjects

  • EndpointSonic DL cardiac-MR validation
  • PopulationSonic DL
  • Tested versionSonic DL
Source

Image-series evaluations

107 series

  • EndpointSonic DL cardiac-MR validation
  • PopulationSonic DL
  • Tested versionSonic DL
Source

Validation sites

7 sites

  • EndpointSonic DL cardiac-MR validation
  • PopulationSonic DL
  • Tested versionSonic DL
Source

Reader radiologists

3 readers

  • EndpointSonic DL cardiac-MR reader study
  • PopulationSonic DL
  • Tested versionSonic DL
Source

K223523 FDA performance package for Sonic DL

  • DesignManufacturer accelerated cardiac-MR reconstruction, image-quality, reader, and accuracy validation
  • Population57 unique subjects, including 46 patients and 11 healthy participants, across 7 sites and cardiac pathologies
  • Scopeexact submission
  • Tested versionSonic DL
  • IndependenceSponsor or vendor study

K223523

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

4 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K223523 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Exact FDA record reviewedStatus
2026-09-19Last searched
26Fields reviewed
12Source classes checked
7Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA support assessed on 2026-09-19. Packet-supported facts: purpose, modality, anatomy; packet-unavailable facts: intendedUsers, input, output, limitations, evidenceSummary. Candidate literature and postmarket candidates remain in their existing review state. Automated exact-name discovery found 7 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, 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 K223523: Sonic DL

    U.S. Food and Drug Administration - Published 2023-05-30 - Accessed 2026-09-19

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. GE HealthCare Sonic DL announcement

    GE HealthCare - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

  8. Clinical utility of a rapid two-dimensional balanced steady-state free precession sequence with deep learning reconstruction.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Clinical evaluation of deep learning-accelerated 3D FLAIR imaging at 1.5T and 3T for visualization of cerebral white matter lesions.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Qualitative and Quantitative Evaluation of a Deep Learning-Based Reconstruction for Accelerated Cardiac Cine Imaging.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Deep Learning-Accelerated 3D Vessel Wall MRI: Prospective Evaluation of Sonic DL with Substantial Scan Time Reduction.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Fast cardiac magnetic resonance (CMR) protocol for biventricular functional assessment and tissue characterisation.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Clinical evaluation of deep learning accelerated 3D magnetic resonance cholangiopancreatography at 1.5 T and 3 T.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. High-Resolution 2D versus 3D Lumbar Spine MRI Optimized with a Deep Learning Reconstruction Algorithm and Prototype Conformal Coil.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Screening and Staging of Benign vs Malignant Pelvic Abnormalities

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K223523 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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