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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K151221
Device Name Kubtec DIGIVIEW 395
Applicant
Kub Technologies, Inc.
270 Rowe Ave., Unit E
Milford,  CT  06461
Applicant Contact VIKRAM BUTANI
Correspondent
Kub Technologies, Inc.
270 Rowe Ave., Unit E
Milford,  CT  06461
Correspondent Contact VIKRAM BUTANI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/07/2015
Decision Date 06/23/2015
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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