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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 K071682
Device Name CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
Applicant
ALARA, INC.
47505 SEABRIDGE DRIVE
FREMONT,  CA  94538
Applicant Contact ROBERT LUNDBERG
Correspondent
ALARA, INC.
47505 SEABRIDGE DRIVE
FREMONT,  CA  94538
Correspondent Contact ROBERT LUNDBERG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/19/2007
Decision Date 08/15/2007
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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