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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K112539
Device Name CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
Applicant
Leiker Regulatory & Quality Consulting
7263 Cronin Cir.
Dublin,  CA  94568
Applicant Contact BOB LEIKER
Correspondent
Leiker Regulatory & Quality Consulting
7263 Cronin Cir.
Dublin,  CA  94568
Correspondent Contact BOB LEIKER
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received09/01/2011
Decision Date 01/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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