WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261795

510(k) cleared

Quicktome Software Suite

Omniscient Neurotechnology Pty, Ltd. · Sep 10, 2026 · K261795 · In the directory

FDA cleared the Quicktome Software Suite from Omniscient Neurotechnology Pty, Ltd. on Sep 10, 2026 under K261795, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 29, 2026. The decision came 104 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Omniscient Neurotechnology Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261795?

K261795 is the FDA 510(k) for Quicktome Software Suite, submitted by Omniscient Neurotechnology Pty, Ltd.. FDA's decision date was Sep 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Quicktome Software Suite?

Omniscient Neurotechnology Pty, Ltd., based in Haymarket, is the applicant of record for K261795. The company is listed in the MedDevice Startups directory.

How long did the K261795 review take?

FDA received the submission on May 29, 2026 and issued its decision on Sep 10, 2026, 104 days later.

← All decisions in September 2026

Sources

In the startup directory

Omniscient Neurotechnology

Neurology & Neurotech · Sydney, Australia