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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Neutron, Medical
510(k) Number K811778
Device Name MODEL 4100 14 MEV NEUTRON GEN. THERAPY
Applicant
The Cyclotron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Cyclotron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.5300
Classification Product Code
IWL  
Date Received06/23/1981
Decision Date 07/23/1981
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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