The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Ge Definium Amx 700, Model Amx 700.
| Device ID | K052897 |
| 510k Number | K052897 |
| Device Name: | GE DEFINIUM AMX 700, MODEL AMX 700 |
| Classification | System, X-ray, Mobile |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI |
| Contact | Mark Stauffer |
| Correspondent | Mark Stauffer GENERAL ELECTRIC MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2005-11-08 |
| Summary: | summary |