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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K053221
Device Name CDMX-H
Applicant
Camsight Co., Inc.
3380 San Fernando Rd.
Los Angeles,  CA  90065
Applicant Contact JAY CHOI
Correspondent
Camsight Co., Inc.
3380 San Fernando Rd.
Los Angeles,  CA  90065
Correspondent Contact JAY CHOI
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/17/2005
Decision Date 01/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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