Data / Medical devices / Australia / Imaxeon Pty Ltd
Imaxeon Pty Ltd: FDA-registered device maker in Rydalmere New South Wales, Australia, 2 510(k) clearances
Imaxeon Pty Ltd is registered with the FDA (registration 3003786696) in Rydalmere New South Wales, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003786696
- Address
- Unit 1, 38-46 South Street, Rydalmere New South Wales, Australia, 2116
- Owner or operator
- Imaxeon Pty Ltd (10092112)
- Roles
- Specification developer
- First device listed
- December 5, 2024
- Registered through
- 2026
- Brand names listed
- MEDRAD Centargo CT Injection System, MEDRAD Centargo Day Set, MEDRAD Centargo Patient Line, MEDRAD Centargo Replacement Spike, MEDRAD ISI2 Module (ISI2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 2 | Specification developer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Specification developer | 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 24, 2025 | K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | IZQ | Substantially Equivalent | Imaxeon Pty, Ltd. | accessdata.fda.gov |
| November 5, 2024 | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | IZQ | Substantially Equivalent | Imaxeon Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 24, 2025. 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.