The following data is part of a premarket notification filed by Trex Medical Corp. with the FDA for Trex Tilt C-arm/table Multipurpose Radiographic/fluoroscopic Positioning System, Trex Tilt-c.
| Device ID | K982427 |
| 510k Number | K982427 |
| Device Name: | TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | TREX MEDICAL CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | William T Cousins |
| Correspondent | William T Cousins TREX MEDICAL CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-09-23 |