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FDA 510(k)

LiverMultiScan v5 (LMSv5)

K-Number: K213960 · 2022-09-06

ApplicantPerspectum
Decision Date2022-09-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LiverMultiScan v5 (LMSv5) is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum. It received FDA 510(k) clearance on 2022-09-06 under 510(k) number K213960. 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 LiverMultiScan v5 (LMSv5)?

LiverMultiScan v5 (LMSv5) is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Perspectum. The 510(k) number is K213960.

When did LiverMultiScan v5 (LMSv5) receive FDA 510(k) clearance?

LiverMultiScan v5 (LMSv5) received FDA 510(k) clearance on 2022-09-06, under 510(k) number K213960.

Who is the listed applicant for LiverMultiScan v5 (LMSv5)?

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

What is the FDA product code for LiverMultiScan v5 (LMSv5)?

The FDA product code for LiverMultiScan v5 (LMSv5) is LNH.

Other records listing Perspectum 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.

K253413LiverMultiScan (v6.0)K241925VitruvianScan (v1.0)K233930MRCP+ version 2 (MRCP+ v2)K230294CoverScan (CoverScan v1.1)K212565CoverScan v1K203280Hepatica v1 (Hepatica v1.0.0)

View all 8 devices →

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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