Rayvolve
Radiological Computer Assisted Detection/diagnosis Software For Fracture
AZmed SAS
The following data is part of a premarket notification filed by Azmed Sas with the FDA for Rayvolve.
Pre-market Notification Details
| Device ID | K220164 |
| 510k Number | K220164 |
| Device Name: | Rayvolve |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Applicant | AZmed SAS 6 Rue Leonard De Vinci Laval, FR 53000 |
| Contact | Patricia Massako |
| Correspondent | Patricia Massako AZmed SAS 6 Rue Leonard De Vinci Laval, FR 53000 |
| Product Code | QBS |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-20 |
| Decision Date | 2022-06-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03770018071022 | K220164 | 000 |
| 03770018071015 | K220164 | 000 |
| 03770018071008 | K220164 | 000 |
Trademark Results [Rayvolve]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAYVOLVE 74103937 1657407 Live/Registered |
TE CONNECTIVITY CORPORATION 1990-10-09 |
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