Catalyst+ SP003
by C-Rad Positioning AB 2 variants
Catalyst+ SP003 (HY-005) is a Class II device made by C-Rad Positioning AB, cleared under FDA 510(k) K200435 on 7 May 2020 and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 17350005280045), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17350005280045 | Date16 Jul 2020 | StatusListed |
| United States | FDA 510(k) | NumberK200435 | Date7 May 2020 | StatusActive |
Official records
- AccessGUDID record 17350005280045
- FDA 510(k) database K200435
Across registries
- FDA 510(k) K200435 decided 7 May 2020 Active
- FDA GUDID UDI-DI 17350005280045 listed 16 Jul 2020 Listed
Recalls
-
- Ongoing Z-1092-2026
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.
-
- Ongoing Z-1858-2025
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Timeline
- Cleared FDA 510(k) K200435
- Listed FDA GUDID 17350005280045
- Recall initiated FDA recalls Z-1858-2025
- Recall initiated FDA recalls Z-1092-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Catalyst+
- Generic name
- Laser patient positioning system
- Model / Ref / Catalog
- SP003, HY-005
- Primary DI / UDI-DI
- 17350005280045
- 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