Data / Medical devices / United States / Imvaria
Imvaria: FDA-registered device maker in Berkeley, CA, United States, 1 510(k) clearance
Imvaria is registered with the FDA (registration 3033729853) in Berkeley, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033729853
- Address
- 2930 Domingo Ave #1496, Berkeley, CA, United States, 94705
- Owner or operator
- IMVARIA (10091350)
- Roles
- Manufacturer
- First device listed
- October 10, 2024
- Registered through
- 2026
- Brand names listed
- Fibresolve, ScreenDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | QWO | 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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K241891 | ScreenDx | QWO | Substantially Equivalent | Imvaria, Inc. | accessdata.fda.gov |
Updated January 10, 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.