The following data is part of a premarket notification filed by Suni Medical Imaging, Inc. with the FDA for X-ray, Tomography, Computed, Dental.
| Device ID | K083917 |
| 510k Number | K083917 |
| Device Name: | X-RAY, TOMOGRAPHY, COMPUTED, DENTAL |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | SUNI MEDICAL IMAGING, INC. 6840 VIA DEL ORO San Jose, CA 95119 -1379 |
| Contact | Al Bettencourt |
| Correspondent | Al Bettencourt SUNI MEDICAL IMAGING, INC. 6840 VIA DEL ORO San Jose, CA 95119 -1379 |
| Product Code | OAS |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MUH |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-30 |
| Decision Date | 2009-06-02 |