FDA 510(k) Application Details - K231577

Device Classification Name System, X-Ray, Mobile

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510(K) Number K231577
Device Name System, X-Ray, Mobile
Applicant Siemens Medical Solutions
40 Liberty Boulevard
Malvern, PA 19355 US
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Contact Camila Rodriguez Valentin
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 05/31/2023
Decision Date 07/25/2023
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



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