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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 AVENUE, UNIT E
MILFORD,  CT  06461
Applicant Contact VIKRAM BUTANI
Correspondent
KUB TECHNOLOGIES, INC
270 ROWE AVENUE, 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
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