Quicktome Software Suite— 510(k) K261795

Name: FDA 510(k) clearance K261795
Creator: U.S. Food and Drug Administration
Published: 2026-09-10

Substantially Equivalent

Omniscient Neurotechnology Pty, Ltd.

FDA 510(k) clearance K261795 for Quicktome Software Suite, Substantially Equivalent on 2026-09-10. Applicant: Omniscient Neurotechnology Pty, Ltd.. Device class: 2.

Summary

Quicktome Software Suite from Omniscient Neurotechnology is filed under QIH, automated radiological image processing software. The record doesn't describe what the software does.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Omniscient Neurotechnology filed from Haymarket, Australia. Review took 104 days (May 29 to September 10, 2026).

Clearance details

Applicant: Omniscient Neurotechnology Pty, Ltd.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-29
Decision date: 2026-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haymarket, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.