FDA 510(k) Application Details - K242512

Device Classification Name System, Image Processing, Radiological

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510(K) Number K242512
Device Name System, Image Processing, Radiological
Applicant Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 PC
Best NL
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Contact Rob Vingerhoed
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/23/2024
Decision Date 10/24/2024
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 K242512


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