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510(k) K070344

LIV BREAST SELF EXAMINATION AID by Liv International USA, Inc. — Product Code IZH

K070344 is an FDA 510(k) premarket notification submitted by Liv International USA, Inc. for the device "LIV BREAST SELF EXAMINATION AID". The FDA issued a decision of Substantially Equivalent on March 8, 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
March 8, 2007
Date Received
February 6, 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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  • 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