The following data is part of a premarket notification filed by Qynapse with the FDA for Qyscore Software.
| Device ID | K192531 |
| 510k Number | K192531 |
| Device Name: | QyScore Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Qynapse 67 Rue Saint Jacques Paris, FR 75005 |
| Contact | Olivier Courreges |
| Correspondent | Michael Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03770016198004 | K192531 | 000 |