Xmaru Pro
Xmaru Pro is a Class II device made by Rayence Co., Ltd., cleared under FDA 510(k) K190866 on 30 Apr 2019 and listed in FDA GUDID since 24 Jul 2020 (UDI-DI 08800018600580), 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 | Number08800018600580 | Date24 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190866 | Date30 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 08800018600580
- FDA 510(k) database K190866
Across registries
- FDA 510(k) K190866 decided 30 Apr 2019 Active
- FDA GUDID UDI-DI 08800018600580 listed 24 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K190866
- Listed FDA GUDID 08800018600580
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Basic x-ray clinical assessment support software
- Model / reference
- Xmaru Pro
- Primary DI / UDI-DI
- 08800018600580
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Basic x-ray clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Basic diagnostic x-ray system application software.