FDA 510(k) Application Details - K242463

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K242463
Device Name System,Planning,Radiation Therapy Treatment
Applicant Varian Medical Systems, Inc
3100 Hansen Way
Palo Alto, CA 64304 US
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Contact Dr. Lynn Allman
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 08/19/2024
Decision Date 12/13/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242463


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