Quicktome Software Suite— 510(k) K261795
Substantially EquivalentOmniscient 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 is Omniscient Neurotechnology's brain mapping software. It builds maps of brain networks from standard MRI scans for neurosurgical planning. It's filed under QIH, automated radiological image processing software.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Omniscient Neurotechnology filed from Haymarket, in central Sydney, Australia. Review took 104 days (May 29 to September 10, 2026). Quicktome has earlier clearances, and a "suite" name suggests this one bundles several modules together.
Clearance details
- Applicant
- Omniscient Neurotechnology Pty, Ltd.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haymarket, AU
Recent devices under product code QIH
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