The following data is part of a premarket notification filed by Ceevra, Inc. with the FDA for Clarity Reveal.
| Device ID | K171356 |
| 510k Number | K171356 |
| Device Name: | Clarity Reveal |
| Classification | System, Image Processing, Radiological |
| Applicant | Ceevra, Inc. 3960 Franke Ln. Lafayette, CA 94549 |
| Contact | Russ Yoshinaka |
| Correspondent | Russ Yoshinaka Ceevra, Inc. 3960 Franke Ln. Lafayette, CA 94549 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00086162500046 | K171356 | 000 |