Axxent Surface Controller 750850
by Icad, Inc.
Axxent Surface Controller 750850 (XP1200) is a Class II device made by Icad, Inc., cleared under FDA 510(k) K153570 on 25 Feb 2016 and listed in FDA GUDID since 20 Oct 2016 (UDI-DI 00858012005526), active as of 22 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 | Number00858012005526 | Date20 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153570 | Date25 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 00858012005526
- FDA 510(k) database K153570
Across registries
- FDA 510(k) K153570 decided 25 Feb 2016 Active
- FDA GUDID UDI-DI 00858012005526 listed 20 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K153570
- Listed FDA GUDID 00858012005526
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Axxent Surface Controller
- Generic name
- General-purpose brachytherapy system applicator, manual
- Model / Ref / Catalog
- 750850, XP1200
- Primary DI / UDI-DI
- 00858012005526
- 510(k) Number
- FDA product code
- JAD
- GMDN term
- General-purpose brachytherapy system applicator, manual
- Device class
- Class II
- Regulation number
- 892.5900
- GUDID distribution status
- In Commercial Distribution
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