The following data is part of a premarket notification filed by Neo Imagery Technologies, Inc. with the FDA for Insight Diagnostic Imaging Workstation Nit-du0-zoo.
| Device ID | K965179 |
| 510k Number | K965179 |
| Device Name: | INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO |
| Classification | System, Image Processing, Radiological |
| Applicant | NEO IMAGERY TECHNOLOGIES, INC. 2315 S. BIRCH LOG WAY Hacienda Heights, CA 91745 |
| Contact | Tina Young |
| Correspondent | Tina Young NEO IMAGERY TECHNOLOGIES, INC. 2315 S. BIRCH LOG WAY Hacienda Heights, CA 91745 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-07-03 |
| Summary: | summary |