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510(k) K050663

TRAXYLOC-1 SYSTEM by Traxyz Medical, Inc. — Product Code IZH

K050663 is an FDA 510(k) premarket notification submitted by Traxyz Medical, Inc. for the device "TRAXYLOC-1 SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 2005. 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
April 8, 2005
Date Received
March 15, 2005
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

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  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
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  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources