The following data is part of a premarket notification filed by Suni Medical Imaging, Inc. with the FDA for Suniray Ii Digital Radiography System.
| Device ID | K070219 |
| 510k Number | K070219 |
| Device Name: | SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SUNI MEDICAL IMAGING, INC. 38 MILLER AVE, PMB 170 Mill Valley, CA 94941 |
| Contact | David Stark |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-23 |
| Decision Date | 2007-02-07 |
| Summary: | summary |