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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 K862294
Device Name THE IMAGE/R
Applicant
Quantum Diagnostics, Ltd.
77 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact WARREN BLAKER,PHD
Correspondent
Quantum Diagnostics, Ltd.
77 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact WARREN BLAKER,PHD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/17/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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