The following data is part of a premarket notification filed by Jazz Imaging Llc with the FDA for Jazz Solo Sensor.
| Device ID | K163224 |
| 510k Number | K163224 |
| Device Name: | JAZZ SOLO Sensor |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Jazz Imaging LLC 800 Charcot Avenue, Suite 100 San Jose, CA 95131 |
| Contact | Todd C. Miller |
| Correspondent | W. Edward Johansen W. Edward Johansen 395 14th Street, NE Salem, OR 97301 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-16 |
| Decision Date | 2017-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867359000309 | K163224 | 000 |