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FDA 510(k)

InVision™ 3T Recharge Operating Suite

K-Number: K252239 · 2025-08-06

ApplicantImris Imaging, Inc.
Decision Date2025-08-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

InVision™ 3T Recharge Operating Suite is the device name listed in this FDA 510(k) record. The listed applicant is Imris Imaging, Inc.. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K252239. 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 InVision™ 3T Recharge Operating Suite?

InVision™ 3T Recharge Operating Suite is a medical device that received FDA 510(k) clearance on 2025-08-06. The listed applicant is Imris Imaging, Inc.. The 510(k) number is K252239.

When did InVision™ 3T Recharge Operating Suite receive FDA 510(k) clearance?

InVision™ 3T Recharge Operating Suite received FDA 510(k) clearance on 2025-08-06, under 510(k) number K252239.

Who is the listed applicant for InVision™ 3T Recharge Operating Suite?

The FDA 510(k) record lists Imris Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InVision™ 3T Recharge Operating Suite?

The FDA product code for InVision™ 3T Recharge Operating Suite is LNH.

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

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

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