# KA Imaging Inc

> Medical device manufacturer record on deviCERTS, compiled from public registries. KA Imaging Inc is a medical device manufacturer based in Canada, with 3 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/ka-imaging-inc>
- Country: Canada (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: CA-MF-000030642
- FDA FEI: 3016256852
- DUNS: 203337746

## Figures

- Devices: 3
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 2, EUDAMED 1, FDA 510(k) 1
- Device classes: FDA Class II 2, EU Class IIa 1
- EMDN [Z11 Bioimaging and radiotherapy instruments](https://devicerts.com/categories/emdn/Z11): 1 devices

## Sites and related companies

- Authorised representative: [Qualrep Services B.V.](https://devicerts.com/representatives/qualrep-services-bv-nl-ar-000000537) (Netherlands)

## Devices

The first 3 of 3, in the order of the canonical page, which lists them all.

- [Reveal 35C 1](https://devicerts.com/devices/reveal-35c-101) · Class II · GUDID · status: Active
- [Flat Panel Detector](https://devicerts.com/devices/flat-panel-detector-mqb-k201591) · ref K201591 · Class II · 510(k) · status: Active · decision 2020-09-03
- [Reveal 35C](https://devicerts.com/devices/reveal-35c-reveal-35c) · Class IIa · EUDAMED, GUDID · status: Expiring

## EU certificates

- 28620131494-01 · Quality management system · MDR · notified body Intertek Medical Notified Body AB · issued 2022-11-17 · expires 2027-08-23 · status: issued

## Source and citation

- Cite as: KA Imaging Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/ka-imaging-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/ka-imaging-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/ka-imaging-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.