Xd 3.6
Xd 3.6 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) K220779 on 15 Apr 2022 (2 earlier submissions) and listed in FDA GUDID since 14 Oct 2016 (UDI-DI B334XD3P60), 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 | FDA 510(k) 510(k) | NumberK220779 | Date15 Apr 2022 | StatusActive |
| United States | GUDID listing GUDID | NumberB334XD3P60 | Date14 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK102687 | Date4 Oct 2010 | StatusActive |
Official records
- FDA 510(k) database K220779
- FDA 510(k) database K102687
- FDA 510(k) database K101228
Across registries
- FDA 510(k) K220779 decided 15 Apr 2022 Active
- FDA GUDID UDI-DI B334XD3P60 listed 14 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K101228
- Cleared FDA 510(k) K102687
- Listed FDA GUDID B334XD3P60
- Cleared FDA 510(k) K220779
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xd
- Generic name
- Radiology picture archiving and communication system workstation
- Model / reference
- 3.6
- Primary DI / UDI-DI
- B334XD3P60
- 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
Similar devices in this category
Other devices filed under Radiology picture archiving and communication system workstation.