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510(k) K935068

RADIOGRAPHIC GENERATOR HFQ-WHIS by Bennett X-Ray Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1993
Date Received
October 25, 1993
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

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  • K945962 — BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY (April 3, 1995)
  • K945749 — BENNETT X-RAY TOMOGRAPHY SYSTEM (February 15, 1995)
  • K945731 — HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS (February 15, 1995)
  • K940701 — BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH (April 28, 1994)
  • K935649 — WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY (February 9, 1994)
  • K925725 — CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR (February 26, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)

Other clearances for product code IZO

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  • K953582 — HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (September 26, 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)
  • K945453 — UD 150L-R II (March 21, 1995)