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510(k) K161920

Comfort Cover by Precision Dynamics Corporation — Product Code IZH

K161920 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corporation for the device "Comfort Cover". The FDA issued a decision of Substantially Equivalent on July 15, 2016. 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
July 15, 2016
Date Received
July 13, 2016
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

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)
  • 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)
  • K113284 — BIOPSY POSITIONER (March 7, 2012)

FDA data resources