The following data is part of a premarket notification filed by J.morita Usa, Inc. with the FDA for Veraview X800.
| Device ID | K171012 |
| 510k Number | K171012 |
| Device Name: | Veraview X800 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | J.Morita USA, Inc. 9 Mason Irvine, CA 92618 |
| Contact | Keisuke Mori |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washingon Dc, DC 20005 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213030798 | K171012 | 000 |