The following data is part of a premarket notification filed by Suni Medical Imaging, Inc. with the FDA for Sunipan Imaging System & Accessories.
| Device ID | K060149 |
| 510k Number | K060149 |
| Device Name: | SUNIPAN IMAGING SYSTEM & ACCESSORIES |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SUNI MEDICAL IMAGING, INC. 6840 VIA DEL ORO, SUITE 160 San Jose, CA 95119 |
| Contact | F. A Bettencourt |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-20 |
| Decision Date | 2006-02-03 |
| Summary: | summary |