The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Versaview Panoramic-cephalometric Dental X-ray Sys..
| Device ID | K974077 |
| 510k Number | K974077 |
| Device Name: | VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS. |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-29 |
| Decision Date | 1998-01-20 |
| Summary: | summary |