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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 K092537
Device Name DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
Applicant
Toshiba America Electronic Components, Inc.
2150 E. Lake Cook Rd.,
Suite 310
Buffalo Grove,  IL  60089
Applicant Contact JOHN KURZYDLO
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.1800
Classification Product Code
MUH  
Date Received08/19/2009
Decision Date 08/27/2009
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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