The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for 3d Accuitomo 150n.
| Device ID | K201378 |
| 510k Number | K201378 |
| Device Name: | 3D Accuitomo 150N |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | J. Morita USA, INC. 9 Mason Irvine, CA 92618 |
| Contact | Fujio Zushi |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W., Suite 1000 Washington Dc, DC 20005 |
| Product Code | OAS |
| Subsequent Product Code | JAK |
| Subsequent Product Code | MUH |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2021-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213053261 | K201378 | 000 |