Omniscient Neurotechnology PTY Ltd (O8t) (manufacturer, Haymarket New South Wales, AU): 2 new FDA device listings, incl. system, image processing, radiological
Omniscient Neurotechnology PTY Ltd (O8t) (Haymarket New South Wales): 2 new FDA device listings, incl. system, image processing, radiological. Its amount of 2 is above the median of 2 (69th percentile). Dated 46 days ago, it serves as a historical benchmark. Score 60/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related AU DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Omniscient Neurotechnology PTY Ltd (O8t) |
| Owner / operator | Omniscient Neurotechnology Pty Ltd (o8t) |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198 |
| Location | Haymarket New South Wales, AU |
| New listings | 2 |
| Devices | System, Image Processing, Radiological; Automated Radiological Image Processing Software |
| Product codes | LLZ, QIH |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Quicktome Software Suite |
| First new listing | 2026-09-21 |
| Latest new listing | 2026-09-21 |
| FDA registration number | 3017102960 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,709 (median 2, 1.0x median) |
| Peer records CSV (25 AU records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Omniscient Neurotechnology PTY Ltd (O8t) and 25 AU peers
- AU DeviceEstablishmentPulse records like this one: 25
- Omniscient Neurotechnology PTY Ltd (O8t)'s amount: 69th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every AU peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Omniscient Neurotechnology PTY Ltd (O8t) in Haymarket New South Wales?
Omniscient Neurotechnology PTY Ltd (O8t) (Haymarket New South Wales, AU), a manufacturer, added 2 FDA device listings on 2026-09-21.
How does Omniscient Neurotechnology PTY Ltd (O8t) compare to other DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 46 days old; check the official source for later updates before acting.
Omniscient Neurotechnology PTY Ltd (O8t) vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Omniscient Neurotechnology PTY Ltd (O8t) | Haymarket New South Wales, AU | 2 | 69th | 2026-09-21 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
Related records
- Applied Medical Resources Corp.
- Inter-Med, Inc.
- Intuitive Surgical, Inc.
- Biomerieux, Inc.
- Intuitive Surgical, Inc.
- Masimo Corporation
- Centerpoint Systems LLC
- Tornier, Inc.
- Treace Medical Concepts, Inc.
- Coopersurgical, Inc.
- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
- Boston Scientific Corporation
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.