Sectra Digital Pathology Module 2.2

Sectra Digital Pathology Module 2.2 is a Class II device made by Sectra AB, cleared under FDA 510(k) K193054 on 31 Mar 2020 and listed in FDA GUDID since 20 Apr 2020 (UDI-DI 07350092810197), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07350092810197 UDI-DI	Date20 Apr 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK193054	Date31 Mar 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07350092810197
FDA 510(k) database 510(k) number K193054

Across registries

2 registries list this device

FDA 510(k) K193054 decided 31 Mar 2020 Active
FDA GUDID UDI-DI 07350092810197 listed 20 Apr 2020 Listed

Timeline

2 dated events

31 Mar 2020 Cleared FDA 510(k) K193054
20 Apr 2020 Listed FDA GUDID 07350092810197

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Sectra Digital Pathology Module
Generic name: Pathology information system
Model / reference: 2.2

Primary DI / UDI-DI: 07350092810197
510(k) Number: K193054
FDA product code: QKQ
GMDN term: Pathology information system

Device class: Class II
Regulation number: 864.3700
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use

Other properties (14, all answered No)