VirtuOst VFA
VirtuOst VFA is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by O.N. Diagnostics, cleared under FDA 510(k) K171435 on 3 Aug 2018 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI 00860000233118), active as of 21 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 | Number00860000233118 | Date15 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171435 | Date3 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00860000233118
- FDA 510(k) database K171435
Across registries
- FDA 510(k) K171435 decided 3 Aug 2018 Active
- FDA GUDID UDI-DI 00860000233118 listed 15 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K171435
- Listed FDA GUDID 00860000233118
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- A
- Primary DI / UDI-DI
- 00860000233118
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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