FDA 510(k) Application Details - K191493

Device Classification Name System, Image Processing, Radiological

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510(K) Number K191493
Device Name System, Image Processing, Radiological
Applicant Ventripoint Diagnostics, Ltd.
2 Sheppard Avenue East, Suite 605
Toronto M2N 5Y7 CA
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Contact Desmond Hirson
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/05/2019
Decision Date 10/16/2019
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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