FDA 510(k) Application Details - K211356

Device Classification Name System, Image Processing, Radiological

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510(K) Number K211356
Device Name System, Image Processing, Radiological
Applicant Motilent Ltd
IDEALondon, 69 Wilson Street
London EC2A 2BB GB
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Contact Ian Knott
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/03/2021
Decision Date 11/08/2021
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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