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FDA 510(k) Application Details - K203822
Device Classification Name
More FDA Info for this Device
510(K) Number
K203822
Device Name
ProFound AI Software V3.0
Applicant
iCAD Inc.
98 Spit Brook Rd. Suite 100
Nashua, NH 03062 US
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Contact
Heather Reed
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Regulation Number
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Classification Product Code
QDQ
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More FDA Info for this Product Code
Date Received
12/29/2020
Decision Date
03/12/2021
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
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