Data / Medical devices / United States / Q Bio
Q Bio: FDA-registered device maker in San Carlos, CA, United States, 1 510(k) clearance
Q Bio is registered with the FDA (registration 3036495186) in San Carlos, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036495186
- Address
- 1411 Industrial Rd, San Carlos, CA, United States, 94070
- Owner or operator
- Q Bio (10092965)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 20, 2025
- Registered through
- 2026
- Brand names listed
- Constellation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 12, 2024 | K241280 | Constellation (CON-001) | QIH | Substantially Equivalent | Q Bio, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated September 12, 2024. 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.