CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE


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 circle
dublin, 
CA 
94568

Applicant Contact bob leiker
Correspondent
LEIKER REGULATORY & QUALITY CONSULTING
7263 cronin circle
dublin, 
CA 
94568

Correspodent Contact bob leiker
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 09/01/2011
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