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FDA 510(k) Application Details - K223532
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K223532
Device Name
System, Image Processing, Radiological
Applicant
Olea Medical
93 Avenue des Sorbiers, ZI ATHELIA IV
La Ciotat 13600 FR
Other 510(k) Applications for this Company
Contact
Nathalie Palumbo
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2022
Decision Date
06/06/2023
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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