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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K121447
Device Name ISCHEMA VIEW RAPID
Applicant
Ischemaview, Inc.
5405 Alton Pkwy. 5a, #530
Irvine,  CA  92604
Applicant Contact MARC GOODMAN
Correspondent
Ischemaview, Inc.
5405 Alton Pkwy. 5a, #530
Irvine,  CA  92604
Correspondent Contact MARC GOODMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/15/2012
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
Predetermined Change
Control Plan Authorized		 No
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