Data / Medical devices / Australia / Incisive Technologies Pty Ltd
Incisive Technologies Pty Ltd: FDA-registered device maker in Ferntree Gully Victoria, Australia, 1 510(k) clearance
Incisive Technologies Pty Ltd is registered with the FDA (registration 3033588343) in Ferntree Gully Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033588343
- Address
- 5 William Street, Ferntree Gully Victoria, Australia, 3156
- Owner or operator
- Incisive Technologies Pty Ltd (10091851)
- Roles
- Manufacturer
- First device listed
- November 7, 2024
- Registered through
- 2026
- Brand names listed
- BlueCheck
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Caries Detection | LFC | 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 |
|---|---|---|---|---|---|---|
| May 16, 2023 | K222560 | BlueCheck Caries Detection & Monitoring | LFC | Substantially Equivalent | Incisive Technologies Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2023. 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.