VirtuOst A
VirtuOst A is a medical device (FDA Class II; FDA product code KGI, Densitometer, Bone) made by O.N. Diagnostics, cleared under FDA 510(k) K113725 on 13 Sep 2012 and listed in FDA GUDID since 15 Aug 2018 (UDI-DI 00860000233101), 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 | Number00860000233101 | Date15 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113725 | Date13 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 00860000233101
- FDA 510(k) database K113725
Across registries
- FDA 510(k) K113725 decided 13 Sep 2012 Active
- FDA GUDID UDI-DI 00860000233101 listed 15 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K113725
- Listed FDA GUDID 00860000233101
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VirtuOst
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- A
- Primary DI / UDI-DI
- 00860000233101
- 510(k) Number
- FDA product code
- KGI
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.1170
- GUDID distribution status
- In Commercial Distribution
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