The following data is part of a premarket notification filed by Trex Medical Corp. with the FDA for Mxu-125 Or Tmx-125.
| Device ID | K992229 |
| 510k Number | K992229 |
| Device Name: | MXU-125 OR TMX-125 |
| Classification | System, X-ray, Mobile |
| Applicant | TREX MEDICAL CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Kelvin Burroughs |
| Correspondent | Kelvin Burroughs TREX MEDICAL CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-02 |
| Decision Date | 1999-08-06 |
| Summary: | summary |