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FDA 510(k) Application Details - K212523
Device Classification Name
More FDA Info for this Device
510(K) Number
K212523
Device Name
VFSS Pro Mobile Digital Imaging System
Applicant
IMAGExRAY, LLC
160 Park Avenue
Nutley, NJ 07110 US
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Contact
Gary Korkola
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Regulation Number
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Classification Product Code
OWB
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Date Received
08/11/2021
Decision Date
11/05/2021
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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