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Sectra Digital Pathology Module 3.4

by Sectra AB

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

Ref 155

Sectra Digital Pathology Module 3.4 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 735009281Pathology_AppKK), cleared under FDA 510(k) K193054 on 31 Mar 2020 and listed in FDA GUDID since 13 Nov 2023 (UDI-DI 07350092810487), 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) K193054

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 Number735009281Pathology_AppKK Basic UDI-DI 07350092810487UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350092810487 UDI-DI Date13 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193054 Date31 Mar 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735009281Pathology_AppKK registered 26 Oct 2026 Active
  • FDA 510(k) K193054 decided 31 Mar 2020 Active
  • FDA GUDID UDI-DI 07350092810487 listed 13 Nov 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193054
  2. Listed FDA GUDID 07350092810487
  3. Registered EUDAMED 735009281Pathology_AppKK

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  • Withdrawn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 Digital Pathology Module 3.4 EUDAMED
Sectra Digital Pathology Module GUDID
Generic name
Pathology information system
Model / reference
155 EUDAMED
3.4 GUDID
Primary DI / UDI-DI
07350092810487
Basic UDI-DI
735009281Pathology_AppKK
Direct marketing DI
07350092810487
510(k) Number
FDA product code
QKQ
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Pathology information system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.3700
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
155
GUDID
3.4
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: Pathology information system

Cleared under the same submission (K193054)

and 4 more cleared under K193054

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)