FDA 510(k) Application Details - K241569

Device Classification Name System, Image Processing, Radiological

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510(K) Number K241569
Device Name System, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc
40 Libertry Boulevard
Malvern, PA 19355 US
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Contact Patricia Jones
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/31/2024
Decision Date 10/11/2024
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 K241569


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