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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 K102148
Device Name CURIEPACS (DICOM PACS SOFTWARE)
Applicant
Moksha Digital Software Pvt Limited
#1611, Janardhana Towers
7th Cross, 19th Main, Sector 1
Hsr Layout, Bangalore,  IN 560034
Applicant Contact DEEPAK SHARMA
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/30/2010
Decision Date 08/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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