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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K103579
Device Name INTRA SKAN DC
Applicant
Skanray Technologies
78 A&B, Hootagalli Industrial
Area
Mysore,  IN 570017
Applicant Contact PARASURAMAPPA BELUR
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/06/2010
Decision Date 03/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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