RTx 1.6
RTx 1.6 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Mirada Medical, Ltd., cleared under FDA 510(k) K130393 on 20 Mar 2013 and listed in FDA GUDID since 28 Mar 2017 (UDI-DI B334RTX1P60), 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 | NumberB334RTX1P60 | Date28 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130393 | Date20 Mar 2013 | StatusActive |
Official records
- FDA 510(k) database K130393
Across registries
- FDA 510(k) K130393 decided 20 Mar 2013 Active
- FDA GUDID UDI-DI B334RTX1P60 listed 28 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K130393
- Listed FDA GUDID B334RTX1P60
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RTx
- Generic name
- Radiology picture archiving and communication system workstation
- Model / reference
- 1.6
- Primary DI / UDI-DI
- B334RTX1P60
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology picture archiving and communication system workstation
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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