Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009771004

FEI Number

3009771004

Entity Name

Kent Imaging Inc

City/State/Country

Calgary Alberta, CA

Establishment Address

Suite 300, 1210 8th Street SW, Calgary Alberta T2R 1L3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kent Imaging Inc. (Owner Number: 10041732)

Owner / Operator Contact Address

Suite 300, 1210 8th Street SW, Calgary, CA-AB T2R 1L3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163070

PMA Number

N/A

All Registered Proprietary Names

Drape KB100 Series SnapshotNIR (KD205) Kent Camera KD203

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-07-07
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2024-07-23
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2012-08-24
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2017-11-09

Official Correspondent

Hitalo Arume

US Agent Details

ERIC Hirabayashi Email: eric@kentimaging.com Phone: (214) 7697828

Related Public Records

Same Entity

Kent 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
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29
K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	2021-12-05

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3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009771004. Last updated year: 2026. Please use registration number 3009771004 when referencing this establishment in official correspondence.