ECHOSOFT(TM)


Device Classification Name

system, image processing, radiological

510(k) Number K111142
Device Name ECHOSOFT(TM)
Applicant
ECHOMETRIX LLC
2210 woodhill way
waukesha, 
WI 
53189

Applicant Contact larry a kroger
Correspondent
ECHOMETRIX LLC
2210 woodhill way
waukesha, 
WI 
53189

Correspodent Contact larry a kroger
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/22/2011
Decision Date 09/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No