The following data is part of a premarket notification filed by Neo Imagery Technologies, Inc. with the FDA for Insight Diagnostic Imaging Workstation.
| Device ID | K982535 |
| 510k Number | K982535 |
| Device Name: | INSIGHT DIAGNOSTIC IMAGING WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | NEO IMAGERY TECHNOLOGIES, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook NEO IMAGERY TECHNOLOGIES, INC. 16303 PANORAMIC WAY San Leandro, CA 94578 -1116 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-12-21 |
| Summary: | summary |