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510(k) K920938

VJW2919 PNEUMATIC COMPRESSION UPGRADE by Varian Canada, Inc. — Product Code IZH

K920938 is an FDA 510(k) premarket notification submitted by Varian Canada, Inc. for the device "VJW2919 PNEUMATIC COMPRESSION UPGRADE". The FDA issued a decision of Substantially Equivalent on June 17, 1992. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Varian Canada, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1992
Date Received
February 27, 1992
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 Varian Canada, Inc.

  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 1995)
  • K923455 — HFG 350, 650, 1050 (December 28, 1992)
  • K913234 — VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY (September 23, 1991)
  • K910820 — VPW 2877E6 X-RAY POWER SUPPLY (March 7, 1991)
  • K904169 — VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY (February 19, 1991)
  • K905855 — VPW2877E7 X RAY POWER SUPPLY (February 13, 1991)

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