ISCHEMA VIEW RAPID


Device Classification Name

system, image processing, radiological

510(k) Number K121447
Device Name ISCHEMA VIEW RAPID
Applicant
ISCHEMA VIEW, INC.
5405 alton parkway 5a, #530
irvine, 
CA 
92604

Applicant Contact marc goodman
Correspondent
ISCHEMA VIEW, INC.
5405 alton parkway 5a, #530
irvine, 
CA 
92604

Correspodent Contact marc goodman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/15/2012
Decision Date 10/04/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No