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FDA 510(k)

MR 5300 and MR 7700 R11 MR Systems

K-Number: K223442 · 2022-12-23

ApplicantPhilips Medical Systems Nederlands B.V.
Decision Date2022-12-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR 5300 and MR 7700 R11 MR Systems is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K223442. 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 MR 5300 and MR 7700 R11 MR Systems?

MR 5300 and MR 7700 R11 MR Systems is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K223442.

When did MR 5300 and MR 7700 R11 MR Systems receive FDA 510(k) clearance?

MR 5300 and MR 7700 R11 MR Systems received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223442.

Who is the listed applicant for MR 5300 and MR 7700 R11 MR Systems?

The FDA 510(k) record lists Philips Medical Systems Nederlands B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MR 5300 and MR 7700 R11 MR Systems?

The FDA product code for MR 5300 and MR 7700 R11 MR Systems is LNH.

Other records listing Philips Medical Systems Nederlands B.V. as applicant

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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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