Sectra Digital Pathology Module 2.3
by Sectra AB
Sectra Digital Pathology Module 2.3 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 21 Apr 2020 (UDI-DI 07350092810241), 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 | Number07350092810241 | Date21 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193054 | Date31 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 07350092810241
- FDA 510(k) database K193054
Across registries
- FDA 510(k) K193054 decided 31 Mar 2020 Active
- FDA GUDID UDI-DI 07350092810241 listed 21 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K193054
- Listed FDA GUDID 07350092810241
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sectra Digital Pathology Module
- Generic name
- Pathology information system
- Model / reference
- 2.3
- Primary DI / UDI-DI
- 07350092810241
- 510(k) Number
- 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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