The following data is part of a premarket notification filed by Trex Medical Corp. with the FDA for Digital Imaging System, Models Digitrex-1000 And Digitrex-2000 (digitrex-x000 Family).
| Device ID | K982120 |
| 510k Number | K982120 |
| Device Name: | DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-16 |
| Decision Date | 1998-09-10 |