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Sectra Workstation 28.1

by Sectra AB

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350092810654 UDI-DI Date12 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sectra Workstation
Generic Name
Radiology picture archiving and communication system workstation
Model / Reference
28.1
Primary DI / UDI-DI
07350092810654
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiology picture archiving and communication system workstation
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K081469)

Show all (12)

Other devices from Sectra AB

See all devices from Sectra AB →

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No