FDA 510(k) Application Details - K242874

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K242874
Device Name System, X-Ray, Tomography, Computed
Applicant Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304 US
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Contact Allman Lynn
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 09/23/2024
Decision Date 11/21/2024
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 K242874


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