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FDA 510(k) Application Details - K222884
Device Classification Name
More FDA Info for this Device
510(K) Number
K222884
Device Name
Rapid NCCT Stroke
Applicant
iSchemaView, Inc.
1120 Washington Ave., Ste 200
Golden, CO 80401 US
Other 510(k) Applications for this Company
Contact
James Rosa
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAS
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More FDA Info for this Product Code
Date Received
09/22/2022
Decision Date
03/02/2023
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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