KA Imaging Inc
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000030642 FEI 3016256852
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.
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 2
- EUDAMED 1
- FDA 510(k) 1
- Device classes
- FDA Class II 2
- EU Class IIa 1
- Top EMDN categories
- Sites and related companies
- Qualrep Services B.V. authorised representative
- Identifiers
- EUDAMED SRN CA-MF-000030642
- FDA FEI 3016256852
- DUNS 203337746
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Qualrep Services B.V.NL
What KA Imaging Inc makes
KA Imaging Inc manufactures flat panel detectors for medical imaging, including the Reveal 35C model, which is designed for use in radiographic and fluoroscopic procedures. These devices capture high-resolution X-ray images for diagnostic purposes, supporting applications in radiology and interventional radiology.
The company’s portfolio includes devices classified as Class II and Class IIa under EU and FDA regulations, with listings in the EUDAQS database (eudamed) and the FDA’s 510(k) clearance registry. The manufacturer is based in Canada.
Catalogue
- Regimes: CE MDR 510(k) Registry: GUDID
Flat Panel Detector Ref K201591
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CA-MF-000030642
- FDA FEI number
- 3016256852
- DUNS number
- 203337746
- EUDAMED status
- Active
- EUDAMED registered name
- KA Imaging Inc.
- EUDAMED abbreviated name
- KAI
- Registered address
- 560, Parkside Drive, N2L 5Z4, Waterloo, Canada
- raqa@kaimaging.com
- PRRC contact
- Sandy Hong
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 23 Aug 2027
Intertek Medical Notified Body AB 2862 1 certificate
- 28620131494-01 Expiring
Quality management system EU MDR
- Issued
- 17 Nov 2022
- Expires
- 23 Aug 2027
Frequently asked questions
How many devices does KA Imaging Inc have in the registry?
The registry currently lists 3 devices for KA Imaging Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list KA Imaging Inc's devices?
Among its 3 most recently registered devices, KA Imaging Inc has devices listed in EUDAMED (1 device), FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do KA Imaging Inc's devices fall under?
Among its 3 most recently registered devices, the classes recorded for KA Imaging Inc's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for KA Imaging Inc?
EUDAMED lists 1 certificate for KA Imaging Inc (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 17 Nov 2022.
What are the newest devices from KA Imaging Inc in the registry?
The most recently registered devices listed for KA Imaging Inc include Reveal 35C 1, Flat Panel Detector and Reveal 35C.