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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 K112132
Device Name KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
Applicant
MEDICATECH USA
8870 RAVELLO COURT
NAPLES,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
MEDICATECH USA
8870 RAVELLO COURT
NAPLES,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/26/2011
Decision Date 11/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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