Data / Medical devices / United States / Leo Cancer Care Incorporated
Leo Cancer Care Incorporated: FDA-registered device maker in Middleton, WI, United States, 1 510(k) clearance
Leo Cancer Care Incorporated is registered with the FDA (registration 3017500061) in Middleton, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017500061
- Address
- 7921 UW Health Court, Middleton, WI, United States, 53562
- Owner or operator
- Leo Cancer Care Incorporated (10077979)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 7, 2020
- Registered through
- 2026
- Brand names listed
- FLASHQ, Marie, PINQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 25, 2025 | K250970 | Marie | JAK | Substantially Equivalent | Leo Cancer Care | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of System, X-Ray, Tomography, Computed
Updated July 25, 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.