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Elements Viewer

by Brainlab SE 3 variants

Ref 04056481139070

Elements Viewer (04056481139070), a medical image management system (EU MDD Class I; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab SE, was registered in EUDAMED on 24 Apr 2024 (Basic UDI-DI B-04056481139070), cleared under FDA 510(k) K153653 on 13 Apr 2016 and listed in FDA GUDID on 2 Aug 2018 (UDI-DI 04056481139070); the registry lists it as withdrawn (EUDAMED), not in commercial distribution (GUDID) as of 24 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153653

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04056481139070 Basic UDI-DI 04056481139070UDI-DIDate24 Apr 2024RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04056481139070 UDI-DI Date2 Aug 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153653 Date13 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04056481139070 registered 24 Apr 2024 Withdrawn
  • FDA 510(k) K153653 decided 13 Apr 2016 Active
  • FDA GUDID UDI-DI 04056481139070 listed 2 Aug 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153653
  2. Listed FDA GUDID 04056481139070
  3. Registered EUDAMED B-04056481139070

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Elements Viewer EUDAMED
Viewer GUDID
Generic name
Medical image management system
Model / reference
04056481139070 EUDAMED
4.0 GUDID
Primary DI / UDI-DI
04056481139070
Basic UDI-DI
B-04056481139070
FDA product code
LLZ
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
Medical image management system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04056481139070
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
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

  • Lot / batch number
Other properties (22, all answered No)