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FDA 510(k)

AIR Recon DL

K-Number: K252379 · 2025-12-23

ApplicantGe Medical Systems, LLC
Decision Date2025-12-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIR Recon DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K252379. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR Recon DL?

AIR Recon DL is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K252379.

When did AIR Recon DL receive FDA 510(k) clearance?

AIR Recon DL received FDA 510(k) clearance on 2025-12-23, under 510(k) number K252379.

Who is the listed applicant for AIR Recon DL?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR Recon DL?

The FDA product code for AIR Recon DL is LNH.

Other records listing Ge Medical Systems, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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