The following data is part of a premarket notification filed by Mic International with the FDA for Image Works Panoura.
| Device ID | K122806 |
| 510k Number | K122806 |
| Device Name: | IMAGE WORKS PANOURA |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | MIC INTERNATIONAL 4-1-17 HONGO BUNKYO-KU Tokyo, JP 113-0033 |
| Contact | Izumi Maruo |
| Correspondent | Izumi Maruo MIC INTERNATIONAL 4-1-17 HONGO BUNKYO-KU Tokyo, JP 113-0033 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2013-03-08 |
| Summary: | summary |