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510(k) K071787

BEMITT, MODEL 0001 by Dja Distributors, LLC — Product Code IZH

K071787 is an FDA 510(k) premarket notification submitted by Dja Distributors, LLC for the device "BEMITT, MODEL 0001". The FDA issued a decision of Substantially Equivalent on October 26, 2007. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2007
Date Received
July 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

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  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources