Data / Medical devices / Australia / See-Mode Technologies Pty Ltd
See-Mode Technologies Pty Ltd: FDA-registered device maker in Melbourne Victoria, Australia, 3 510(k) clearances
See-Mode Technologies Pty Ltd is registered with the FDA (registration 3042248552) in Melbourne Victoria, Australia. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042248552
- Address
- 3/162 Collins St, Melbourne Victoria, Australia, 3000
- Owner or operator
- See-Mode Technologies Pty Ltd (10082266)
- Roles
- Manufacturer
- First device listed
- July 8, 2021
- Registered through
- 2026
- Brand names listed
- AVA (Augmented Vascular Analysis), See-Mode Augmented Reporting Tool, Breast (SMART-B), See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | QDQ | 2 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| July 28, 2026 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | QDQ | Substantially Equivalent | See-Mode Technologies Pty, Ltd. | accessdata.fda.gov |
| September 9, 2024 | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | QDQ | Substantially Equivalent | See-Mode Technologies Pte, Ltd. | accessdata.fda.gov |
| September 16, 2020 | K201369 | AVA (Augmented Vascular Analysis) | LLZ | Substantially Equivalent | See-Mode Technologies Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- All makers of System, Image Processing, Radiological
Updated July 28, 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.