Data / Medical devices / United Kingdom / ENVISIONIT DEEP AI Ltd
ENVISIONIT DEEP AI Ltd: FDA-registered device maker in Cobham Surrey, United Kingdom, 1 510(k) clearance
ENVISIONIT DEEP AI Ltd is registered with the FDA (registration 3030491946) in Cobham Surrey, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030491946
- Address
- Coveham House, Downside Bridge Road, Cobham, KT11 3 EP, United Kingdom, Cobham Surrey, United Kingdom, KT11 3 EP
- Owner or operator
- Envisionit Deep AI (10090083)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 13, 2024
- Registered through
- 2026
- Brand names listed
- Pulmira Triage
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 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 |
|---|---|---|---|---|---|---|
| January 17, 2024 | K231871 | Radify Triage | QFM | Substantially Equivalent | Envisionit Deepai, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 17, 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.