Cleared Traditional

Quicktome Software Suite (K222359) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222359 · Omniscient Neurotechnology Pty Ltd (O8t) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
299d
Days
Class 2
Risk

K222359 is an FDA 510(k) clearance for the Quicktome Software Suite. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Omniscient Neurotechnology Pty Ltd (O8t) (Sydney, AU). The FDA issued a Cleared decision on May 30, 2023 after a review of 299 days - an extended review cycle.

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-to-high 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 (O8t) devices

Submission Details

510(k) Number K222359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2022
Decision Date May 30, 2023
Days to Decision 299 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
192d slower than avg
Panel avg: 107d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K222359.
Ambra PACS
K231360 · Dicom Grid Dba Ambra Health · Jun 2023
Olea S.I.A. Neurovascular V1.0
K223532 · Olea Medical · Jun 2023
Brainomix 360 e-CTP
K223555 · Brainomix Limited · Jun 2023
KBA3D
K223841 · S.M.A.I.O · May 2023
Pre-Sure
K230044 · Lazarus 3D · May 2023
Avatar Medical Software V1
K222035 · Avatar Medical · May 2023