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510(k) K964576

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

K964576 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "PROFILE MAMMOGRAPHY SYSTEM (M-PRO)". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

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)

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