FDA 510(k) Application Details - K242300

Device Classification Name

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510(K) Number K242300
Device Name MI View&GO
Applicant Siemens Medical Solutions USA, Inc.
2501 North Barrington Road
Hoffman Estates, IL 60192 US
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Contact Brian Wui
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Regulation Number

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Classification Product Code QIH
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Date Received 08/02/2024
Decision Date 08/30/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242300


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