Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016256852

FEI Number

3016256852

Entity Name

KA IMAGING INC.

City/State/Country

Waterloo Ontario, CA

Establishment Address

560 Parkside Drive #3, Waterloo Ontario N2L 5Z4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KA Imaging Inc. (Owner Number: 10078351)

Owner / Operator Contact Address

560 Parkside Drive #3, Waterloo, CA-ON N2L 5Z4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201591

PMA Number

N/A

All Registered Proprietary Names

Reveal 35C Flat Panel Detector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2020-10-19

Official Correspondent

Amol Karnick

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

KA Imaging Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number	Establishment Name	Location
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP
1000181430	CANON INC.	Kawasaki Kanagawa, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016256852. Last updated year: 2026. Please use registration number 3016256852 when referencing this establishment in official correspondence.