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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 K010784
Device Name PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
Applicant
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact ROBERT APPLEBAUM
Correspondent
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact ROBERT APPLEBAUM
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/15/2001
Decision Date 04/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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