Quicktome Software Suite

FDA 510(k) K222359 · Omniscient Neurotechnology Pty Ltd (O8t)

Substantially Equivalent

510(k) numberK222359

Submission

Device name
Quicktome Software Suite
Applicant
Omniscient Neurotechnology Pty Ltd (O8t)
Sydney, AU
Received
August 4, 2022
Decision date
May 30, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Quicktome Software Suite cleared by the FDA?

Quicktome Software Suite (K222359) received a 510(k) decision of Substantially Equivalent on May 30, 2023, 299 days after the submission was received.

What is the product code of K222359?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.