510(k) K984414
K984414 is an FDA 510(k) premarket notification submitted by Trex Medical Corp. for the device "XRE COLLIMATOR WITH SPECTRAL FILTER". The FDA issued a decision of Substantially Equivalent on December 30, 1998. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610. Trex Medical Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1998
- Date Received
- December 10, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, Automatic, Radiographic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type