Data / Medical devices / Australia / 4dmedical Limited
4dmedical Limited: FDA-registered device maker in Carlton Victoria, Australia, 9 510(k) clearances
4dmedical Limited is registered with the FDA (registration 3017426576) in Carlton Victoria, Australia. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017426576
- Address
- Level 7 Melbourne Connect, 700 Swanston Street, Carlton Victoria, Australia, 3053
- Owner or operator
- 4DMedical Limited (10077775)
- Roles
- Manufacturer
- First device listed
- September 21, 2020
- Registered through
- 2026
- Brand names listed
- CT LVAS, CT Lung Ventilation Analysis Software, CT:V, CT:VQ, IQ - UIP, Imbio CAC Software, Imbio Segmentation Editing Tool: Imbio SET, LDA Lung Density Analysis and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | QWO | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| August 28, 2025 | K251484 | CT:VQ | JAK | Substantially Equivalent | 4Dmedical Limited | accessdata.fda.gov |
| December 19, 2024 | K242467 | IQ-UIP | QWO | Substantially Equivalent | Imbio, Inc. | accessdata.fda.gov |
| August 30, 2024 | K241847 | Imbio PHA (4.0.0) | QIH | Substantially Equivalent | Imbio, Inc. | accessdata.fda.gov |
| November 16, 2023 | K232392 | CT Lung Ventilation Analysis Software (CT:V) | JAK | Substantially Equivalent | 4Dmedical Limited | accessdata.fda.gov |
| June 13, 2023 | K230112 | CAC Software | JAK | Substantially Equivalent | Imbio, Inc. | accessdata.fda.gov |
| March 9, 2021 | K203256 | Imbio RV/LV Software | QIH | Substantially Equivalent | Imbio, LLC | accessdata.fda.gov |
| May 14, 2020 | K193293 | XV Lung Ventilation Analysis Software | JAK | Substantially Equivalent | 4Dx Limited | accessdata.fda.gov |
| March 16, 2018 | K180129 | Imbio Segmentation Editing Tool software | LLZ | Substantially Equivalent | Imbio, LLC | accessdata.fda.gov |
| September 17, 2014 | K141069 | Lung Density Analysis | JAK | Substantially Equivalent | Imbio, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated August 28, 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.