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LiverMultiScan 2.0

by Perspectum

LiverMultiScan 2.0 is a Class II device made by Perspectum, cleared under FDA 510(k) K172685 on 21 Nov 2017 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI B554LMS2000), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K172685

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB554LMS2000 UDI-DI Date26 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172685 Date21 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172685 decided 21 Nov 2017 Active
  • FDA GUDID UDI-DI B554LMS2000 listed 26 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172685
  2. Listed FDA GUDID B554LMS2000

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LiverMultiScan
Generic name
MRI system application software
Model / reference
2.0
Primary DI / UDI-DI
B554LMS2000
510(k) Number
FDA product code
LNH
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

Cleared under the same submission (K172685)

Similar devices in this category

Other devices filed under MRI system application software.

Other devices from Perspectum

See all devices from Perspectum →

Properties

  • Serial number
Other properties (14, all answered No)