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LiverMultiScan

by Perspectum Ltd

Model v6.1, v3.5.0Ref 3.5.0, LiverMultiScan v5510(k) K253413

LiverMultiScan (v6.1) is a device classified as Class IIa in the EU and Class II in the US made by Perspectum, Ltd., registered in EUDAMED on 12 Dec 2025 (Basic UDI-DI 5056849LMSGV) with CE/MDR certificate SCAR-22.2.1.1 valid until 21 May 2029, cleared under FDA 510(k) K253413 on 9 Mar 2026 (1 earlier submission) and listed in FDA GUDID since 12 Sep 2026 (UDI-DI 05056849000010), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

21 May 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Scarlet NB B.V.

510(k) K253413↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05056849000010 UDI-DI Date12 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberSCAR-22.2.1.1 Date28 Jul 2026IssuedStatusActive expires 21 May 2029
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253413 Date9 Mar 2026ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5056849LMSGV registered 12 Dec 2025 Active· +1 more in the status table
  • FDA 510(k) K253413 decided 9 Mar 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05056849000010 listed 12 Sep 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-22.2.1.1 Restricted

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    28 Jul 2026
    Expires
    21 May 2029
    Reason
    Not on market

Timeline

6 dated events

  1. Cleared FDA 510(k) K202170
  2. Registered EUDAMED 5056849LMSGV
  3. Cleared FDA 510(k) K253413
  4. Certificate issued EUDAMED SCAR-22.2.1.1
  5. Listed FDA GUDID 05056849000010
  6. Certificate expires EUDAMED SCAR-22.2.1.1

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Abdominal organ CT/MRI clinical assessment support software
Device name
LiverMultiScan v5
Model / reference
v6.1 EUDAMED
v3.5.0 EUDAMED
3.5.0 EUDAMED
LiverMultiScan v5 EUDAMED
v6.x GUDID
Primary DI / UDI-DI
05056849000010, *+B554LMS30B*, +B554LMS50D
Basic UDI-DI
5056849LMSGV, B-*+B554LMS30B*, ++B554LMSST
510(k) Number
FDA product code
LNH
EMDN code
Z11059082 Various magnetic resonance imaging instruments - software accessories
GMDN term
Abdominal organ CT/MRI clinical assessment support software
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1000
Special device type
Software
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Netherlands
Portugal
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / referenceEUDAMED
v6.1
v3.5.0
3.5.0
LiverMultiScan v5
510(k)
—
GUDID
v6.x
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
GB-MF-000016685
Authorised representative
Perspectum Unipessoal Lda PT-AR-000009160

Similar devices in this category

Other devices filed under VARIOUS MAGNETIC RESONANCE IMAGING (MRI) INSTRUMENTS.

Other devices from Perspectum, Ltd.

  • CoverScan v1

    Class II

  • VitruvianScan (v1.0)

    Class II

  • Mrcp+

    Class I

Properties

  • Measuring function YesEUDAMEDNoEUDAMED
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)