The following data is part of a premarket notification filed by Ge Healthcare Technologies with the FDA for Amx5 And Amx5d Mobile X-ray Systems.
| Device ID | K042866 |
| 510k Number | K042866 |
| Device Name: | AMX5 AND AMX5D MOBILE X-RAY SYSTEMS |
| Classification | System, X-ray, Mobile |
| Applicant | GE HEALTHCARE TECHNOLOGIES P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | D. Duersteler |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-02 |
| Summary: | summary |