FDA 510(k) Application Details - K244049

Device Classification Name System, X-Ray, Mobile

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510(K) Number K244049
Device Name System, X-Ray, Mobile
Applicant LIVERMORETECH INC
801 north Jupiter rd suite 200
Plano, TX 75074 US
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Contact Casey Lee
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 12/31/2024
Decision Date 05/28/2025
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 K244049


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