VIRTUOST
System, X-ray, Tomography, Computed
O.N. DIAGNOSTICS
The following data is part of a premarket notification filed by O.n. Diagnostics with the FDA for Virtuost.
Pre-market Notification Details
| Device ID | K113725 |
| 510k Number | K113725 |
| Device Name: | VIRTUOST |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | O.N. DIAGNOSTICS 2150 SHATTUCK AVE. SUITE 610 Berkeley, CA 94704 |
| Contact | David Kopperdahl |
| Correspondent | David Kopperdahl O.N. DIAGNOSTICS 2150 SHATTUCK AVE. SUITE 610 Berkeley, CA 94704 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-09-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000233101 | K113725 | 000 |
Trademark Results [VIRTUOST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIRTUOST 77956999 3869685 Live/Registered |
O.N. Diagnostics, LLC 2010-03-11 |
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