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Sectra Workstation 27.1

by Sectra AB

Part of a family of 6 devices: see the family page

Ref 101

Sectra Workstation 27.1 is a device classified as Class IIa in the EU and Class II in the US made by Sectra AB, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 735009281Radiology_App7J), cleared under FDA 510(k) K081469 on 12 Jun 2008 and listed in FDA GUDID since 8 Apr 2025 (UDI-DI 07350092810579), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081469

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735009281Radiology_App7J Basic UDI-DI 07350092810579UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350092810579 UDI-DI Date8 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK081469 Date12 Jun 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735009281Radiology_App7J registered 26 Oct 2026 Active
  • FDA 510(k) K081469 decided 12 Jun 2008 Active
  • FDA GUDID UDI-DI 07350092810579 listed 8 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081469
  2. Listed FDA GUDID 07350092810579
  3. Registered EUDAMED 735009281Radiology_App7J

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  • Withdrawn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
Sectra Workstation 27.1 EUDAMED
Sectra Workstation GUDID
Generic name
Radiology picture archiving and communication system workstation
Model / reference
101 EUDAMED
27.1 GUDID
Primary DI / UDI-DI
07350092810579
Basic UDI-DI
735009281Radiology_App7J
Direct marketing DI
07350092810579
510(k) Number
FDA product code
LLZ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiology picture archiving and communication system workstation
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
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
101
GUDID
27.1
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.

Related devices

Category: Radiology picture archiving and communication system workstation

Cleared under the same submission (K081469)

and 8 more cleared under K081469

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Sectra AB

See all devices from Sectra AB →

Properties

  • Measuring function
  • Prescription use
Other properties (23, all answered No)