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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 K102479
Device Name ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
Applicant
ALARA, INC.
47505 SEABRIDGE DRIVE
FREMONT,  CA  94538
Applicant Contact CHRISTOPHER MITCHELL
Correspondent
ALARA, INC.
47505 SEABRIDGE DRIVE
FREMONT,  CA  94538
Correspondent Contact CHRISTOPHER MITCHELL
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/30/2010
Decision Date 06/02/2011
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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