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LiverMultiScan (LMSv3)

by Perspectum Diagnostics, Ltd.

510(k) K190017

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190017↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK190017 Date27 Jun 2019ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LiverMultiScan (LMSv3) is a System, Nuclear Magnetic Resonance Imaging device (product code LNH) designed for non-invasive assessment of liver health. It provides standardized, quantitative metrics to evaluate liver disease by leveraging MRI technology to deliver precise diagnostic insights without invasive procedures.

This device is used in radiology settings and is supplied as a reusable system with MRI-compatible components. Authorized under FDA 510(k) clearance (K190017), MDD, and MDR compliance, it operates within Class II regulatory standards. No sterility or single-use specifications are indicated in the provided data.

Other devices from Perspectum Diagnostics, Ltd.

  • LiverMultiScan

    Class II

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of liver conditions can the LiverMultiScan (LMSv3) help assess, and how does it work?

    The LiverMultiScan (LMSv3) is designed for non-invasive assessment of liver health, providing standardized, quantitative metrics to evaluate liver disease. It leverages MRI technology to deliver precise diagnostic insights without invasive procedures, making it useful for identifying and monitoring conditions like fibrosis, steatosis, or cirrhosis by quantifying liver tissue properties.

  • Is the LiverMultiScan (LMSv3) a single-use device, or can it be reused in clinical settings?

    The LiverMultiScan (LMSv3) is supplied as a reusable system with MRI-compatible components. Since it is not indicated as single-use in the provided data, it is intended for repeated use in radiology settings, provided proper maintenance and cleaning protocols are followed.

  • What regulatory pathways has the LiverMultiScan (LMSv3) undergone, and where is it authorized?

    The LiverMultiScan (LMSv3) has been authorized under FDA 510(k) clearance (K190017), as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). This places it within Class II regulatory standards, ensuring it meets stringent safety and performance requirements for use in radiology settings.

  • How is the LiverMultiScan (LMSv3) integrated into existing MRI systems, and what compatibility considerations should be noted?

    The LiverMultiScan (LMSv3) is designed as a system compatible with MRI technology, meaning it integrates with existing MRI infrastructure in radiology departments. Since it is explicitly labeled as MRI-compatible, no additional hardware modifications are required, but users should ensure proper calibration and adherence to MRI safety protocols for all components.

  • Are there specific storage requirements or handling instructions for the LiverMultiScan (LMSv3) system?

    The provided data does not specify sterility or single-use requirements, but as a reusable system, the LiverMultiScan (LMSv3) should be stored in a clean, controlled environment to prevent contamination. Manufacturer guidelines (available from Perspectum Diagnostics) should be followed for maintenance, calibration, and storage to ensure optimal performance and longevity of MRI-compatible components.