The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Veraview Ic 5, Model Xdp1.
| Device ID | K053220 |
| 510k Number | K053220 |
| Device Name: | VERAVIEW IC 5, MODEL XDP1 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K ST. N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2006-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548213026302 | K053220 | 000 |