Cleared Traditional

K261795 - Quicktome Software Suite

K261795 is an FDA 510(k) clearance for Quicktome Software Suite, manufactured by Omniscient Neurotechnology Pty, Ltd.. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K261795 · Omniscient Neurotechnology Pty, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
104d
Days
Class 2
Risk

K261795 is an FDA 510(k) clearance for the Quicktome Software Suite. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Omniscient Neurotechnology Pty, Ltd. (Haymarket, AU). The FDA issued a Cleared decision on September 10, 2026 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Omniscient Neurotechnology Pty, Ltd. devices

FDA 510(k) Submission Details - K261795

510(k) Number K261795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date September 10, 2026
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 329
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K261795.
EchoPAC Software Only / EchoPAC Plug-in (v211)
K261623 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2026
Artificial Intelligence Renal Assessment (AIRA) Version 1
K261677 · Aramis Global AI Consultancies, LLC · Sep 2026
4DM
K260879 · INVIA, LLC · Sep 2026
ReVISION 2
K251417 · Argus Cognitive, Inc. · Sep 2026
NextMR Spine
K260525 · MRI2CT, Inc. · Sep 2026
Heartvue.Proton
K260811 · Heartvue.ai, Inc. · Aug 2026