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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K920506
Device Name CONTOURING DEVICE
Applicant
X-Icon Medical Systems
124h Blossom Hill Rd.
Suite 401
San Jose,  CA  95123
Applicant Contact CHET HEFLIN
Correspondent
X-Icon Medical Systems
124h Blossom Hill Rd.
Suite 401
San Jose,  CA  95123
Correspondent Contact CHET HEFLIN
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received02/05/1992
Decision Date 10/14/1992
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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