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Anatomage Table 5.0.1

by Anatomage, Inc.

Anatomage Table 5.0.1 is a Class II device made by Anatomage, Inc., cleared under FDA 510(k) K140093 on 7 Mar 2014, registered in EUDAMED and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 00852060007013), active as of 22 Oct 2026.

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

CE MDR 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) K140093

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00852060007013 UDI-DI Date30 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK140093 Date7 Mar 2014IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K140093 decided 7 Mar 2014 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00852060007013 listed 30 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140093
  2. Listed FDA GUDID 00852060007013

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  • Withdrawn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 · GUDID

Trade name
Anatomage Table
Generic name
Radiology information system application software
Model / reference
5.0.1
Primary DI / UDI-DI
00852060007013
510(k) Number
FDA product code
LLZ
GMDN term
Radiology information system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiology information system application software

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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Properties

  • Lot / batch number
Other properties (14, all answered No)