Data / Medical devices / Canada / Limbus Ai
Limbus Ai: FDA-registered device maker in Toronto Ontario, Canada, 3 510(k) clearances
Limbus Ai is registered with the FDA (registration 3017927156) in Toronto Ontario, Canada. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 9, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017927156
- Address
- 30 Adelaide St. East - 12th Floor, Toronto Ontario, Canada, M5C 3G8
- Owner or operator
- Limbus AI (10080198)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 18, 2021
- Registered through
- 2027
- Brand names listed
- Limbus Contour
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Image Processing Software For Radiation Therapy | QKB | 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 |
|---|---|---|---|---|---|---|
| October 9, 2024 | K241837 | Limbus Contour | QKB | Substantially Equivalent | Limbus Ai, Inc. | accessdata.fda.gov |
| April 7, 2023 | K230575 | Limbus Contour | LLZ | Substantially Equivalent | Limbus Ai, Inc. | accessdata.fda.gov |
| August 13, 2020 | K201232 | Limbus Contour | LLZ | Substantially Equivalent | Limbus Ai, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Radiological Image Processing Software For Radiation Therapy
Updated October 9, 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.