The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for 3d Accu-i-tomo Xyz Slice View Tomograph, Model Mct-1 Exf.
| Device ID | K052587 |
| 510k Number | K052587 |
| Device Name: | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington, DC 20005 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-12-27 |
| Summary: | summary |