Data / Medical devices / United States / Elucid Bioimaging
Elucid Bioimaging: FDA-registered device maker in Boston, MA, United States, 2 510(k) clearances
Elucid Bioimaging is registered with the FDA (registration 3013660213) in Boston, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013660213
- Address
- 399 Boylston Street Suite 400, Boston, MA, United States, 02116
- Owner or operator
- Elucid Bioimaging, Inc. (10055068)
- Roles
- Manufacturer
- First device listed
- October 22, 2026
- Registered through
- 2027
- Brand names listed
- Elucid FFR-IQ, Elucid PlaqueIQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coronary Vascular Physiologic Simulation Software | PJA | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| September 29, 2026 | K262015 | Elucid FFR-IQ (B.1) | PJA | Substantially Equivalent | Elucid Bioimaging, Inc. | accessdata.fda.gov |
| September 18, 2026 | K261855 | Elucid PlaqueIQ | LLZ | Substantially Equivalent | Elucid Bioimaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Coronary Vascular Physiologic Simulation Software
Updated September 29, 2026. 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.