Data / Medical devices / United States / Valkyrie Bioscience, Inc
Valkyrie Bioscience, Inc: FDA-registered device maker in Lindon, UT, United States, 1 510(k) clearance
Valkyrie Bioscience, Inc is registered with the FDA (registration 3045366281) in Lindon, UT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045366281
- Address
- 1453 West 40 South Suite 200, Lindon, UT, United States, 84042
- Owner or operator
- Valkyrie BioScience, Inc (10095698)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 15, 2026
- Registered through
- 2026
- Brand names listed
- Lumos 3DX, Lumos Vue
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Complaint file establishment, Specification developer | 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 6, 2023 | K223780 | Lumos 3DX | EHD | Substantially Equivalent | 3Dio | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Unit, X-Ray, Extraoral With Timer
Updated July 6, 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.