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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 K121800
Device Name POINT 500 HD POINT500C HD
Applicant
Pointnix Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact JIGAR SHAH
Correspondent
Pointnix Co., Ltd.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact JIGAR SHAH
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/19/2012
Decision Date 01/24/2013
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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