FDA 510(k) Application Details - K233599

Device Classification Name System, Image Processing, Radiological

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510(K) Number K233599
Device Name System, Image Processing, Radiological
Applicant LG Electronics Inc.
71, Magokjungang 8-ro, Gangseo-gu
Seoul 07795 KR
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Contact Hanseul Park
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/09/2023
Decision Date 03/18/2024
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 K233599


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