The following data is part of a premarket notification filed by O.n. Diagnostics, Llc. with the FDA for Virtuost Vertebral Fracture Assessment.
| Device ID | K171435 |
| 510k Number | K171435 |
| Device Name: | VirtuOst Vertebral Fracture Assessment |
| Classification | System, Image Processing, Radiological |
| Applicant | O.N. Diagnostics, LLC. 2150 Shattuck Ave. Suite 610 Berkeley, CA 94704 |
| Contact | David Kopperdahl |
| Correspondent | David Kopperdahl O.N. Diagnostics, LLC. 2150 Shattuck Ave. Suite 610 Berkeley, CA 94704 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-15 |
| Decision Date | 2018-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000233118 | K171435 | 000 |