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FDA 510(k) Application Details - K172418
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K172418
Device Name
System, Image Processing, Radiological
Applicant
Novarad Corporation
752 East 1180 South #200
American Fork, UT 84003 US
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Contact
Doug Merrill
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Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
08/10/2017
Decision Date
09/21/2018
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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