Home / 510(k) Clearances / K843437

510(k) K843437

MEI MAMMOGRAPHY SYS MX-2049 by Moti Enterprises, Inc. — Product Code IZH

K843437 is an FDA 510(k) premarket notification submitted by Moti Enterprises, Inc. for the device "MEI MAMMOGRAPHY SYS MX-2049". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Moti Enterprises, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1984
Date Received
September 4, 1984
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 Moti Enterprises, Inc.

  • K810095 — MOTI APRON (February 12, 1981)
  • K802377 — MOTI PROTECTIVE X-RAY MASK (October 31, 1980)

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