Sectra Workstation 21.1
by Sectra AB
Sectra Workstation 21.1 is a Class II device made by Sectra AB, cleared under FDA 510(k) K081469 on 12 Jun 2008 and listed in FDA GUDID since 23 Aug 2019 (UDI-DI 07350092810166), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350092810166 | Date23 Aug 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081469 | Date12 Jun 2008 | StatusActive |
Official records
- AccessGUDID record 07350092810166
- FDA 510(k) database K081469
Across registries
- FDA 510(k) K081469 decided 12 Jun 2008 Active
- FDA GUDID UDI-DI 07350092810166 listed 23 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K081469
- Listed FDA GUDID 07350092810166
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sectra Workstation
- Generic name
- Radiology picture archiving and communication system workstation
- Model / reference
- 21.1
- Primary DI / UDI-DI
- 07350092810166
- 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
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