The following data is part of a premarket notification filed by General Robotic Devices, Inc. with the FDA for Imaging Jet System.
| Device ID | K970782 |
| 510k Number | K970782 |
| Device Name: | IMAGING JET SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Non-image-intensified |
| Applicant | GENERAL ROBOTIC DEVICES, INC. 2069 GOLFSIDE DR. Ypsilanti, MI 48197 |
| Contact | Yansong Shan |
| Correspondent | Yansong Shan GENERAL ROBOTIC DEVICES, INC. 2069 GOLFSIDE DR. Ypsilanti, MI 48197 |
| Product Code | JAB |
| CFR Regulation Number | 892.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-11-13 |
| Summary: | summary |