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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K000209
Device Name DOSE 1
Applicant
Scanditronix Wellhofer North America
3111 Stage Post Dr., Suite 105
Bartlett,  TN  38133
Applicant Contact CHUCK LINDLEY
Correspondent
Scanditronix Wellhofer North America
3111 Stage Post Dr., Suite 105
Bartlett,  TN  38133
Correspondent Contact CHUCK LINDLEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/24/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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