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FDA 510(k) Application Details - K182177
Device Classification Name
More FDA Info for this Device
510(K) Number
K182177
Device Name
Accipiolx
Applicant
MaxQ-Al Ltd.
76 Yigal Alon Street, 5th Floor
Tel Aviv 6706701 IL
Other 510(k) Applications for this Company
Contact
Joshua Schulman
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/2018
Decision Date
10/26/2018
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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