The following data is part of a premarket notification filed by Trex Medical Corp. with the FDA for Contour 2000 Mammography System, Model Ctr- 2000.
| Device ID | K984091 |
| 510k Number | K984091 |
| Device Name: | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 |
| Classification | System, X-ray, Mammographic |
| Applicant | TREX MEDICAL CORP. 445 OAK ST. Copiague, NY 11726 -2719 |
| Contact | Walter F Schneider |
| Correspondent | Walter F Schneider TREX MEDICAL CORP. 445 OAK ST. Copiague, NY 11726 -2719 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 1999-02-05 |
| Summary: | summary |