FDA-cleared profile
Ge Medical Systems, LLC
AIR Recon DL adds a deep-learning phase-correction and reconstruction option to supported GE 1.5T, 3T, and 7T MR workflows for all labeled anatomies and ages to reduce noise or ringing and support image quality or scan-time choices.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Prior source-backed dossier value: MR technologists and trained operators, with reconstructed images interpreted by trained physicians.
Prior source-backed dossier value: Hospital and outpatient diagnostic MRI departments.
Prior source-backed dossier value: Image reconstruction and phase correction after MR data acquisition and before diagnostic interpretation.
Prior source-backed dossier value: Compatible raw MR acquisition data, including multiple intermediate images for supported diffusion workflows.
Prior source-backed dossier value: Reconstructed MR images with reduced noise or ringing and phase-corrected combined images.
Prior source-backed dossier value: Acquisition-time savings and image-quality effects depend on sequence, anatomy, field strength, protocol, and workflow. The feature does not itself establish diagnostic accuracy or shorter total room time.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing. Prior source-backed dossier value: Embedded reconstruction on compatible GE MR platforms; validate DICOM appearance, scaling, quantitative maps, protocol transfer, and downstream analysis.
This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence. Prior source-backed dossier value: Licensed reconstruction software on compatible GE 1.5T, 3T, or 7T MR system configurations.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence. 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.
Prior source-backed dossier value: Only mr technologists and trained operators, with reconstructed images interpreted by trained physicians. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service. Prior source-backed dossier value: Monitor by exact hardware, software and model 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 the limits that matter for this product: Acquisition-time savings and image-quality effects depend on sequence, anatomy, field strength, protocol, and workflow. The feature does not itself establish diagnostic accuracy or shorter total room time.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K252379 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Embedded reconstruction on compatible GE MR platforms; validate DICOM appearance, scaling, quantitative maps, protocol transfer, and downstream analysis.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
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. Acquisition-time savings and image-quality effects depend on sequence, anatomy, field strength, protocol, and workflow. The feature does not itself establish diagnostic accuracy or shorter total room time.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model 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 the limits that matter for this product: Acquisition-time savings and image-quality effects depend on sequence, anatomy, field strength, protocol, and workflow. The feature does not itself establish diagnostic accuracy or shorter total room time.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
The FDA material describes software integrated into supported GE MR systems and enabled by an option key; current scanner configuration, service, security, and upgrade boundaries remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Prior source-backed dossier value: K252379 reports phantom and in-vivo brain diffusion testing. Four brain scans with synthetic low-contrast inserts showed significantly improved contrast-to-noise with phase correction while retaining contrast, and ADC testing reduced low-SNR bias. Independent product-family workflow literature should not be treated as exact-version validation.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below. Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below. Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Synthetic-object contrast and contrast-to-noise comparison in AIR Recon DL.
Tested version: AIR Recon DL with phase correction cleared in K252379Manufacturer phantom and in-vivo brain diffusion comparison of deep-learning phase correction and PC-ARDL against the predicate reconstruction · Brain diffusion images at 1.5T across b-values of 50, 400, 800, and 1200 s/mm2, including four scans used for low-contrast insert testing
exact submission · Tested version: AIR Recon DL with phase correction cleared in K252379 · n=4 · Sponsor or vendor studyK252379
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
Prior source-backed dossier value: No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals. Prior source-backed dossier value: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K252379 by exact submission identifier.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 12 PubMed and one ClinicalTrials.gov record. AIR Recon DL records do not link their tested release to the K252379 phase-correction configuration, while the remaining records are generic reconstruction studies; all 13 were quarantined and none was promoted. The current discovery snapshot contains 12 PubMed and 1 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, vendor product page, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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