Radiology AI Directory

FDA-cleared profile

AIR Recon DL

GE Medical Systems,LLC (GE Healthcare)

Optional integrated GE MRI reconstruction removes noise and ringing from supported 1.5T, 3T, and 7T acquisitions across all ages and anatomies, including selected PROPELLER and 3D sequences.

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.

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
Optional integrated GE MRI reconstruction removes noise and ringing from supported 1.5T, 3T, and 7T acquisitions across all ages and anatomies, including selected PROPELLER and 3D sequences.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Qualified MRI technologists and interpreting physicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospital and outpatient MRI departments using compatible GE MRI systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Integrated MR image reconstruction that reduces noise or artifacts before routine professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Raw MRI acquisition data from supported scanners, coils, anatomies, and pulse sequences.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Reconstructed MR image series for review and archival.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
Performance depends on supported scanner, field strength, coil, sequence, anatomy, acceleration, and input quality; reconstructed images remain subject to physician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

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
K213717
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-06-08
  • 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 export; validate reconstruction labels, geometry, quantitative values, PACS display, and downstream compatibility.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Licensed software integrated into supported GE MRI scanner configurations.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
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 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 these product-specific limits: Performance depends on supported scanner, field strength, coil, sequence, anatomy, acceleration, and input quality; reconstructed images remain subject to physician review.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K213717 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 export; validate reconstruction labels, geometry, quantitative values, PACS display, and downstream compatibility.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

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 supported scanner, field strength, coil, sequence, anatomy, acceleration, and input quality; 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

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

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 these product-specific limits: Performance depends on supported scanner, field strength, coil, sequence, anatomy, acceleration, and input quality; reconstructed images remain subject to physician review.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

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
K213717 reports phantom testing and a clinical reader study of 133 cases representing 129 patients from 10 sites, including 51 cases at 1.5T and 82 at 3T.
  • 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 acquisition, 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 acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Clinical reader-study cases

133 cases

  • EndpointAIR Recon DL image-quality evaluation
  • PopulationAIR Recon DL
  • Tested versionAIR Recon DL release cleared in K213717
Source

Patient records

129 patients

  • EndpointClinical reader-study population
  • PopulationAIR Recon DL
  • Tested versionAIR Recon DL release cleared in K213717
Source

K213717 FDA performance package for AIR Recon DL

  • DesignManufacturer phantom testing and multicenter clinical reader study
  • Population133 MRI cases across 1.5T and 3T systems, multiple anatomies, and supported sequences
  • Scopeexact submission
  • Tested versionAIR Recon DL release cleared in K213717
  • Samplen=133
  • Sites10
  • IndependenceSponsor or vendor study

K213717

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

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
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, enabled features, 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 K213717 by exact submission identifier. This does not exclude product-family or later safety 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.

Human reviewedStatus
2026-09-04Last searched
24Fields reviewed
9Source classes checked
12Awaiting 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 materials, available current product-family sources, reimbursement context, and exact-identifier postmarket results were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 12 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, reimbursement policy, fda device recall, 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. K213717 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  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 AIR Recon DL

    GE HealthCare - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

Research history

  1. K213717 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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