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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 K103348
Device Name DIGIVIEW 250
Applicant
Kub Technologies, Inc.
270 Rowe Ave.
Suite E
Milford,  CT  06460
Applicant Contact VIKRAM BUTANI
Correspondent
Kub Technologies, Inc.
270 Rowe Ave.
Suite E
Milford,  CT  06460
Correspondent Contact VIKRAM BUTANI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/15/2010
Decision Date 10/20/2011
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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