FDA 510(k) Application Details - K222361

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K222361
Device Name System, X-Ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern, PA 19355 US
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Contact Kira Kuzmenchuk
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 08/04/2022
Decision Date 10/20/2022
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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