FDA 510(k) Application Details - K233622

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K233622
Device Name Accelerator, Linear, Medical
Applicant Vision RT Ltd
Dove House, Arcadia Avenue
London N3 2JU GB
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Contact Ludlow Chelsey
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 11/13/2023
Decision Date 03/29/2024
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 K233622


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