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Volpara Scorecard

by Lunit International Limited 2 variants

Ref 4.4

Volpara Scorecard (4.4) is a radiological PACS-dedicated management software (EU MDD Class I; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Lunit International Limited, registered in EUDAMED on 22 Sep 2025 (Basic UDI-DI B-09421904268241), cleared under FDA 510(k) K153427 on 7 Jan 2016 and listed in FDA GUDID since 1 Oct 2020 (UDI-DI 09421904268241), active as of 22 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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) K153427

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-09421904268241 Basic UDI-DI 09421904268241UDI-DIDate22 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number09421904268241 UDI-DI Date1 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153427 Date7 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-09421904268241 registered 22 Sep 2025 Active
  • FDA 510(k) K153427 decided 7 Jan 2016 Active
  • FDA GUDID UDI-DI 09421904268241 listed 1 Oct 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153427
  2. Listed FDA GUDID 09421904268241
  3. Registered EUDAMED B-09421904268241

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Volpara Scorecard EUDAMED
VolparaDensity GUDID
Generic name
Radiological PACS-dedicated management software
Device name
Volpara Imaging Software
Model / reference
4.4 EUDAMED
4.0 GUDID
Primary DI / UDI-DI
09421904268241
Basic UDI-DI
B-09421904268241
510(k) Number
FDA product code
LLZ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4.4
GUDID
4.0
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
NZ-MF-000004537
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Lunit International Limited

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)