The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Interventional Mobile Digital Imaging System (herein Called Imdis).
| Device ID | K974355 |
| 510k Number | K974355 |
| Device Name: | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Ted L Parrot |
| Correspondent | Ted L Parrot GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-19 |
| Decision Date | 1998-02-17 |
| Summary: | summary |