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510(k) K854510

MINXRAY 500M MAMMOGRAPHIC SYSTEM by Minxray, Inc. — Product Code IZH

K854510 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "MINXRAY 500M MAMMOGRAPHIC SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 1, 1986. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Minxray, Inc. has 17 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 1, 1986
Date Received
Nov 12, 1985
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
510(k)

Other clearances by Minxray, Inc.

  • K210479 — IMPACT and X-Ranger (Mar 19, 2021)
  • K201575 — CMDR 2C (Multiple Models) (Jul 8, 2020)
  • K191451 — CMDR 2CW (Multiple models) (Jul 3, 2019)
  • K182207 — TR90BH (Dec 14, 2018)
  • K171353 — CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (Jun 7, 2017)
  • K153059 — HF1202H PowerPlus Portable X-ray Equipment (Feb 2, 2016)
  • K141885 — CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY (Sep 18, 2014)
  • K091255 — MINXRAY, MODEL: BPD60 (May 12, 2010)
  • K100449 — MINXRAY MODEL CMDR-2S (Apr 23, 2010)
  • K082627 — MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL (Nov 7, 2008)

Other clearances for product code IZH

  • K203509 — SMART FINDER (Jul 14, 2021)
  • K202294 — Affirm Contrast Biopsy (Oct 5, 2020)
  • K191495 — Biopsy Positioner (Jul 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (Aug 10, 2016)
  • K161920 — Comfort Cover (Jul 15, 2016)
  • K153486 — Affirm Prone Biopsy System (Apr 1, 2016)
  • K152038 — MammoGRIP (Dec 22, 2015)
  • K123414 — SPECBOARD JR. (Jan 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (Jan 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (Aug 10, 2012)

FDA data resources