Data / Medical devices / Canada / Ka Imaging Inc.
Ka Imaging Inc.: FDA-registered device maker in Waterloo Ontario, Canada, 1 510(k) clearance
Ka Imaging Inc. is registered with the FDA (registration 3016256852) in Waterloo Ontario, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016256852
- Address
- 560 Parkside Drive #3, Waterloo Ontario, Canada, N2L 5Z4
- Owner or operator
- KA Imaging Inc. (10078351)
- Roles
- Manufacturer
- First device listed
- October 19, 2020
- Registered through
- 2026
- Brand names listed
- Flat Panel Detector, Reveal 35C
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 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 3, 2020 | K201591 | Flat Panel Detector | MQB | Substantially Equivalent | Ka Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 3, 2020. 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.