CTXA Hip Extended Reference Data K030330
CTXA Hip Extended Reference Data K030330 (DI_CTXAHIPEXTDB) is a Class II device made by Mindways Software, Inc., cleared under FDA 510(k) K030330 on 20 Jun 2003 and listed in FDA GUDID since 31 Mar 2017 (UDI-DI B052DICTXAHIPEXTDB0), 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 | NumberB052DICTXAHIPEXTDB0 | Date31 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030330 | Date20 Jun 2003 | StatusActive |
Official records
- FDA 510(k) database K030330
Across registries
- FDA 510(k) K030330 decided 20 Jun 2003 Active
- FDA GUDID UDI-DI B052DICTXAHIPEXTDB0 listed 31 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K030330
- Listed FDA GUDID B052DICTXAHIPEXTDB0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CTXA Hip Extended Reference Data
- Generic name
- CT system application software
- Model / Ref / Catalog
- K030330, DI_CTXAHIPEXTDB
- Primary DI / UDI-DI
- B052DICTXAHIPEXTDB0
- 510(k) Number
- FDA product code
- KGI
- GMDN term
- CT system application software
- Device class
- Class II
- Regulation number
- 892.1170
- GUDID distribution status
- In Commercial Distribution