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510(k) K984091

CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 by Trex Medical Corp. — Product Code IZH

K984091 is an FDA 510(k) premarket notification submitted by Trex Medical Corp. for the device "CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000". The FDA issued a decision of Substantially Equivalent on February 5, 1999. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Trex Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1999
Date Received
November 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
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)
  • 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)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources