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510(k) K953582

HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR by Varian Canada, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1995
Date Received
August 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

Other clearances by Varian Canada, Inc.

  • K923455 — HFG 350, 650, 1050 (December 28, 1992)
  • K920938 — VJW2919 PNEUMATIC COMPRESSION UPGRADE (June 17, 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 IZO

  • K954666 — MPH50, MPH65, AND MPH80 (November 24, 1995)
  • K953831 — N 800 HF (September 8, 1995)
  • K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (July 12, 1995)
  • K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X- (July 6, 1995)
  • K950883 — POLYDOROS SX 65 AND 80 (April 3, 1995)
  • K950694 — COMPACT-X (March 31, 1995)
  • K950291 — DIGITAL 625HF (March 23, 1995)
  • K950041 — SII 360 APR (March 21, 1995)
  • K950040 — SII 525 APR (March 21, 1995)
  • K945453 — UD 150L-R II (March 21, 1995)