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Table

by Anatomage, Inc.

Ref SW-TST-902Model 9

Table (SW-TST-902) is a device classified as Class IIa in the EU and Class II in the US made by Anatomage, Inc., registered in EUDAMED on 27 Dec 2023 (Basic UDI-DI 0852060007Table9G3), cleared under FDA 510(k) K140093 on 7 Mar 2014 and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 00852060007259), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140093↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0852060007Table9G3 Basic UDI-DI 00852060007259UDI-DIDate27 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00852060007259 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK140093 Date7 Mar 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0852060007Table9G3 registered 27 Dec 2023 Active
  • FDA 510(k) K140093 decided 7 Mar 2014 Active
  • FDA GUDID UDI-DI 00852060007259 listed 25 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140093
  2. Listed FDA GUDID 00852060007259
  3. Registered EUDAMED 0852060007Table9G3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Radiology information system application software
Model / reference
9 EUDAMED
SW-TST-902 EUDAMED
9.0 GUDID
Primary DI / UDI-DI
00852060007259
Basic UDI-DI
0852060007Table9G3
Direct marketing DI
00852060007259
510(k) Number
FDA product code
LLZ
EMDN code
Z12040182 General medicine diagnosis and monitoring instruments - software accessories
GMDN term
Radiology information system application software
Device class
Class IIa 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
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
9
SW-TST-902
GUDID
9.0
Device classEUDAMED
Class IIa
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000027423
Authorised representative
Freyr Regulatory GmbH DE-AR-000047121

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Anatomage, Inc.

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    Class II

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    Class II

  • TxStudio 7.0

    Class II

See all devices from Anatomage, Inc. →

Properties

  • Measuring function
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)