Data / Medical devices / Australia / Voyager Imaging
Voyager Imaging: FDA-registered device maker in Hawthorn East Victoria, Australia, 1 510(k) clearance
Voyager Imaging is registered with the FDA (registration 3007005340) in Hawthorn East Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 11, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007005340
- Address
- L 1 123 Camberwell Road, Hawthorn East Victoria, Australia, 3123
- Owner or operator
- INTELLIRAD SOLUTIONS PTY LTD (9090019)
- Roles
- Manufacturer
- First device listed
- August 16, 2006
- Registered through
- 2026
- Brand names listed
- Voyager PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | 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 11, 2006 | K062062 | VOYAGER PACS SYSTEM | LLZ | Substantially Equivalent | Voyager Imaging | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2006. 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.