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FDA 510(k) Application Details - K222359
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K222359
Device Name
System, Image Processing, Radiological
Applicant
Omniscient Neurotechnology Pty Ltd (O8t)
Level 10, 580 George Street
Sydney 2000 AU
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Contact
Jennifer Dixon
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
08/04/2022
Decision Date
05/30/2023
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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