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510(k) K984414

XRE COLLIMATOR WITH SPECTRAL FILTER by Trex Medical Corp. — Product Code IZW

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

Other clearances by Trex Medical Corp.

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  • K982427 — TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM (September 23, 1998)
  • K982120 — DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FA (September 10, 1998)

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  • K031597 — DUNLEE FORMAT COLLIMATOR FAMILY (July 21, 2003)
  • K990423 — PHILIPS NICOL COLLIMATOR FAMILY (March 15, 1999)