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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, Charged-Particle, Medical
510(k) Number K860606
Device Name RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM
Applicant
Bionix Corp.
2140 Old Planke Rd.
Holland,  OH  43528
Applicant Contact HUTTNER, M.D.
Correspondent
Bionix Corp.
2140 Old Planke Rd.
Holland,  OH  43528
Correspondent Contact HUTTNER, M.D.
Regulation Number892.5050
Classification Product Code
LHN  
Date Received02/19/1986
Decision Date 03/20/1986
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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