Catalyst SP002
Catalyst SP002 is a Class II device made by C-Rad Positioning AB, cleared under FDA 510(k) K113276 on 27 Feb 2012 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 07350005280024), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07350005280024 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK113276 | Date27 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 07350005280024
- FDA 510(k) database K113276
Across registries
- FDA 510(k) K113276 decided 27 Feb 2012 Active
- FDA GUDID UDI-DI 07350005280024 listed 22 Sep 2016 Listed
Recalls
-
- Terminated Z-2075-2021
PC Application Software c4D not changing Site upon synchronization during the Setup workflow step
Timeline
- Cleared FDA 510(k) K113276
- Listed FDA GUDID 07350005280024
- Recall initiated FDA recalls Z-2075-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Catalyst
- Generic name
- Laser patient positioning system
- Model / reference
- SP002
- Primary DI / UDI-DI
- 07350005280024
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Laser patient positioning system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Laser patient positioning system.