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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K133620
Device Name CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
Applicant
Imaging Sciences International
1910 N. Penn Rd.
Hatfield,  PA  19454
Applicant Contact RUTH PUI
Correspondent
Imaging Sciences International
1910 N. Penn Rd.
Hatfield,  PA  19454
Correspondent Contact RUTH PUI
Regulation Number892.1750
Classification Product Code
OAS  
Date Received11/25/2013
Decision Date 05/14/2014
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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