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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 K031801
Device Name PANTOS, MODELS: PANTOS 16, AND PANTOS DG
Applicant
Blue X Imaging Srl
251 E. Dundee Rd. Suite #6
Wheeling,  IL  60090
Applicant Contact AL SOSA
Correspondent
Blue X Imaging Srl
251 E. Dundee Rd. Suite #6
Wheeling,  IL  60090
Correspondent Contact AL SOSA
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Codes
EHD   MQB  
Date Received06/11/2003
Decision Date 09/11/2003
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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