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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K261795
Device Name Quicktome Software Suite
Applicant
Omniscient Neurotechnology Pty, Ltd.
Suite L1.108, 477 Pitt St.
Haymarket,  AU 2000
Applicant Contact Arie Henkin
Correspondent
Omniscient Neurotechnology Pty, Ltd.
Suite L1.108, 477 Pitt St.
Haymarket,  AU 2000
Correspondent Contact Arie Henkin
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received05/29/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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