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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K092522
Device Name ACU007S
Applicant
Oncology Systems, Inc.
206 N Randolph St., Suite 301
Champaign,  IL  61820
Applicant Contact JENNIFER WILLIAMS
Correspondent
Oncology Systems, Inc.
206 N Randolph St., Suite 301
Champaign,  IL  61820
Correspondent Contact JENNIFER WILLIAMS
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/18/2009
Decision Date 11/20/2009
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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