Data / Medical devices / Canada / Mach7 Technologies Canada Inc.
Mach7 Technologies Canada Inc.: FDA-registered device maker in Waterloo Ontario, Canada, 1 510(k) clearance
Mach7 Technologies Canada Inc. is registered with the FDA (registration 3009601121) in Waterloo Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009601121
- Address
- 103 Bauer Place Suite 3, Waterloo Ontario, Canada, N2L 6B5
- Owner or operator
- Mach7 Technologies Inc. (10024474)
- Roles
- Manufacturer
- First device listed
- December 16, 2020
- Registered through
- 2026
- Brand names listed
- eUnity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| February 6, 2018 | K172490 | eUnity | LLZ | Substantially Equivalent | Client Outlook, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 6, 2018. 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.