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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K222359
Device Name Quicktome Software Suite
Applicant
Omniscient Neurotechnology Pty Ltd (O8t)
Level 10, 580 George St.
Sydney,  AU 2000
Applicant Contact Jennifer Dixon
Correspondent
Omniscient Neurotechnology Pty Ltd (O8t)
Level 10, 580 George St.
Sydney,  AU 2000
Correspondent Contact Jennifer Dixon
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/04/2022
Decision Date 05/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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