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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 K032210
Device Name ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
Applicant
Alara, Inc.
2545 Barrington Ct.
Hayward,  CA  94545
Applicant Contact DIANE M KING
Correspondent
Alara, Inc.
2545 Barrington Ct.
Hayward,  CA  94545
Correspondent Contact DIANE M KING
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/21/2003
Decision Date 10/02/2003
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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