TxStudio 6.0
TxStudio 6.0 is a radiology information system application software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Anatomage, Inc., cleared under FDA 510(k) K123519 on 1 Feb 2013 and listed in FDA GUDID since 20 Dec 2017 (UDI-DI 00852060007037), 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 | Number00852060007037 | Date20 Dec 2017 | StatusListed |
| United States | FDA 510(k) | NumberK123519 | Date1 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 00852060007037
- FDA 510(k) database K123519
Across registries
- FDA 510(k) K123519 decided 1 Feb 2013 Active
- FDA GUDID UDI-DI 00852060007037 listed 20 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K123519
- Listed FDA GUDID 00852060007037
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- Withdrawn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
- 6.0
- Primary DI / UDI-DI
- 00852060007037
- 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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