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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 K141329
Device Name RADSPA
Applicant
TELERAD TECH PRIVATE LIMITED
2871 COASTAL DR.
AURORA,  IL  60503
Applicant Contact MANOJ ZACHARIAS
Correspondent
TELERAD TECH PRIVATE LIMITED
2871 COASTAL DR.
AURORA,  IL  60503
Correspondent Contact MANOJ ZACHARIAS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/21/2014
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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