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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 K060149
FOIA Releasable 510(k) K060149
Device Name SUNIPAN IMAGING SYSTEM & ACCESSORIES
Applicant
Suni Medical Imaging, Inc.
6840 Via Del Oro Suite 160
San Jose,  CA  95119
Applicant Contact F. A BETTENCOURT
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/20/2006
Decision Date 02/03/2006
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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