Quicktome Software Suite
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222359 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quicktome Software Suite is a connectomic analysis platform designed for advanced brain mapping and functional imaging analysis. It leverages AI-enabled post-processing to analyze MRI and resting-state functional MRI (rs-fMRI) data, generating detailed insights into patient-specific brain networks and connectivity patterns. This software supports neurosurgical planning by providing precise, actionable visualizations of brain structures and pathways.
The Quicktome Software Suite is supplied as a digital platform for use in clinical settings, including neurosurgical planning environments. It is intended for single-use per patient analysis, with no specified sterility requirements as it is non-invasive software. The system operates under FDA 510(k) clearance (K222359) and EU MDR compliance, with no restrictions on MRI safety as it is not a physical device. No physical storage or disposal requirements apply beyond standard IT infrastructure protocols.
Frequently asked questions
What clinical applications is the Quicktome Software Suite primarily designed for, and how does it support neurosurgical planning?
The Quicktome Software Suite is specifically designed for advanced brain mapping and functional imaging analysis, particularly leveraging MRI and resting-state functional MRI (rs-fMRI) data. It uses AI-enabled post-processing to generate detailed, patient-specific insights into brain networks and connectivity patterns. This helps clinicians visualize critical brain structures and pathways, making it a valuable tool for neurosurgical planning by providing precise, actionable visualizations to inform surgical strategies.
Is the Quicktome Software Suite intended for reuse or single-use, and what are the implications for its use in a clinical setting?
The Quicktome Software Suite is intended for single-use per patient analysis, meaning each analysis session is dedicated to one patient’s data. Since it is a digital platform with no physical components, there are no sterility requirements or disposal considerations beyond standard IT protocols. This ensures a clean, patient-specific workflow without the need for reprocessing or sterilization.
How is the Quicktome Software Suite supplied, and are there any special handling or storage requirements beyond standard IT infrastructure?
The Quicktome Software Suite is supplied exclusively as a digital platform, requiring no physical storage or disposal beyond standard IT infrastructure protocols. Since it is non-invasive software, there are no sterility or environmental handling requirements. It operates entirely within clinical IT systems, making deployment straightforward as long as the necessary hardware and software compatibility are met.
What regulatory pathways does the Quicktome Software Suite follow, and how does this affect its use in the U.S. and EU markets?
The Quicktome Software Suite has obtained FDA 510(k) clearance under the reference number K222359, confirming it is deemed substantially equivalent to a predicate device. It also complies with EU Medical Device Regulation (MDR). These approvals ensure its use is authorized in both the U.S. and EU markets, though clinicians should confirm local compliance and IT integration requirements with their institution’s regulatory and IT teams.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Quicktome by Omniscient Neurotechnology | SDV Medical, o8t - Hyperpersonalized Brain Care | Omniscient Neurotechnology, Omniscient Neurotechnology Pty Quicktome Software…
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222359 | Class II | Active |
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Manufacturer
- Manufacturer
- Omniscient Neurotechnology Pty Ltd (O8t)
Sources (2)
- FDA 510(k) K222359 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026