The following data is part of a premarket notification filed by Ceevra, Inc. with the FDA for Ceevra Reveal 2.0.
| Device ID | K173274 |
| 510k Number | K173274 |
| Device Name: | Ceevra Reveal 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Ceevra, Inc. 180 Sansome St., 2nd Floor San Francisco, CA 94194 |
| Contact | Russ Yoshinaka |
| Correspondent | Rory A. Carrillo RAC Medical LLC 368 San Carlos St. San Francisco, CA 94104 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-12 |
| Decision Date | 2018-07-10 |
| Summary: | summary |