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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K123357
Device Name ONQ RTS
Applicant
Oncology Systems, Inc.
14 Longbow Professional Centre
Longbow Close
Shrewsbury, Shropshire,  GB SY1 3GZ
Applicant Contact CARL WALKER
Correspondent
Oncology Systems, Inc.
14 Longbow Professional Centre
Longbow Close
Shrewsbury, Shropshire,  GB SY1 3GZ
Correspondent Contact CARL WALKER
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LLZ  
Date Received10/31/2012
Decision Date 12/28/2012
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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