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510(k) K992229

MXU-125 OR TMX-125 by Trex Medical Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1999
Date Received
July 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Trex Medical Corp.

  • K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 (February 5, 1999)
  • K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 (February 5, 1999)
  • K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER (December 30, 1998)
  • 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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