FDA 510(k) Application Details - K232923

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K232923
Device Name Accelerator, Linear, Medical
Applicant Varian Medical Systems Inc.
3100 Hansen Way
Palo Alto, CA 94304 US
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Contact Lynn Allman
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 09/19/2023
Decision Date 04/30/2024
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 K232923


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