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510(k) K964576

PROFILE MAMMOGRAPHY SYSTEM (M-PRO) by Bennett X-Ray Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
November 14, 1996
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 Bennett X-Ray Corp.

  • K952672 — VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM (July 13, 1995)
  • K944978 — BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI (May 3, 1995)
  • 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)
  • K935068 — RADIOGRAPHIC GENERATOR HFQ-WHIS (December 13, 1993)
  • K925725 — CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR (February 26, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)

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