Data / Medical devices / Australia / Omniscient Neurotechnology Pty Ltd (o8t)
Omniscient Neurotechnology Pty Ltd (o8t): FDA-registered device maker in Haymarket New South Wales, Australia, 3 510(k) clearances
Omniscient Neurotechnology Pty Ltd (o8t) is registered with the FDA (registration 3017102960) in Haymarket New South Wales, Australia. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017102960
- Address
- Suite L1.108, 477 Pitt Street, Haymarket New South Wales, Australia, 2000
- Owner or operator
- Omniscient Neurotechnology Pty Ltd (o8t) (10080969)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 10, 2021
- Registered through
- 2026
- Brand names listed
- Quicktome, Quicktome Software Suite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 10, 2026 | K261795 | Quicktome Software Suite | QIH | Substantially Equivalent | Omniscient Neurotechnology Pty, Ltd. | accessdata.fda.gov |
| May 30, 2023 | K222359 | Quicktome Software Suite | LLZ | Substantially Equivalent | Omniscient Neurotechnology Pty Ltd (O8t) | accessdata.fda.gov |
| March 9, 2021 | K203518 | Quicktome | LLZ | Substantially Equivalent | Omniscient Neurotechnology Pty Ltd (O8t) | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.