The following data is part of a premarket notification filed by Suni Medical Imaging, Inc with the FDA for Suniiq Digital Radiography System.
| Device ID | K162585 |
| 510k Number | K162585 |
| Device Name: | SuniIQ Digital Radiography System |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Suni Medical Imaging, Inc 6840 Via Del Oro Suite 160 San Jose, CA 95119 |
| Contact | Al Bettencourt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851067007057 | K162585 | 000 |