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510(k) K982120

DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY) by Trex Medical Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1998
Date Received
June 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Trex Medical Corp.

  • K992229 — MXU-125 OR TMX-125 (August 6, 1999)
  • 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)

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