The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Amx-4 Plus Mobile X-ray System.
| Device ID | K021016 |
| 510k Number | K021016 |
| Device Name: | AMX-4 PLUS MOBILE X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-17 |
| Summary: | summary |