TxStudio 7.0
TxStudio 7.0 is a Class II device made by Anatomage, Inc., cleared under FDA 510(k) K123519 on 1 Feb 2013 and listed in FDA GUDID since 17 Nov 2023 (UDI-DI 00852060007266), 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 | Number00852060007266 | Date17 Nov 2023 | StatusListed |
| United States | FDA 510(k) | NumberK123519 | Date1 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 00852060007266
- FDA 510(k) database K123519
Across registries
- FDA 510(k) K123519 decided 1 Feb 2013 Active
- FDA GUDID UDI-DI 00852060007266 listed 17 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K123519
- Listed FDA GUDID 00852060007266
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TxStudio
- Generic name
- Radiology information system application software
- Model / reference
- 7.0
- Primary DI / UDI-DI
- 00852060007266
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology information system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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