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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 K992303
Device Name SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
Applicant
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact RALPH E SHUPING
Correspondent
Nucletron Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact RALPH E SHUPING
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/08/1999
Decision Date 03/27/2000
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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