The following data is part of a premarket notification filed by Trex Medical Corp. with the FDA for Xre Collimator With Spectral Filter.
| Device ID | K984414 |
| 510k Number | K984414 |
| Device Name: | XRE COLLIMATOR WITH SPECTRAL FILTER |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | TREX MEDICAL CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Contact | Wayne V Loomer |
| Correspondent | Wayne V Loomer TREX MEDICAL CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-10 |
| Decision Date | 1998-12-30 |