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Viewer, 5.2

by Brainlab SE

Ref 04056481143619

Viewer, 5.2 (04056481143619) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, registered in EUDAMED on 30 Jun 2025 (Basic UDI-DI 4056481ViewerPW), cleared under FDA 510(k) K191014 on 23 Jan 2020 and listed in FDA GUDID since 10 May 2021 (UDI-DI 04056481143619), withdrawn (EUDAMED), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is 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) K191014

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/MDR EUDAMED Number4056481ViewerPW Basic UDI-DI 04056481143619UDI-DIDate30 Jun 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04056481143619 UDI-DI Date10 May 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191014 Date23 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4056481ViewerPW registered 30 Jun 2025 Withdrawn
  • FDA 510(k) K191014 decided 23 Jan 2020 Active
  • FDA GUDID UDI-DI 04056481143619 listed 10 May 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191014
  2. Listed FDA GUDID 04056481143619
  3. Registered EUDAMED 4056481ViewerPW

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Viewer, 5.2 EUDAMED
Elements Viewer GUDID
Generic name
Medical image management system
Device name
Viewer
Model / reference
04056481143619 EUDAMED
5.2 GUDID
Primary DI / UDI-DI
04056481143619
Basic UDI-DI
4056481ViewerPW
Direct marketing DI
04056481143619
510(k) Number
FDA product code
LLZ
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
Medical image management system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481143619
GUDID
5.2
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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
DE-MF-000006183

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)