Data / Medical devices / Canada / Kent Imaging Inc

Kent Imaging Inc: FDA-registered device maker in Calgary Alberta, Canada, 5 510(k) clearances

Name: Kent Imaging Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kent Imaging Inc is registered with the FDA (registration 3009771004) in Calgary Alberta, Canada. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 26, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009771004
Address: Suite 300, 1210 8th Street SW, Calgary Alberta, Canada, T2R 1L3
Owner or operator: Kent Imaging Inc. (10041732)
Roles: Manufacturer, Specification developer
First device listed: August 24, 2012
Registered through: 2026
Brand names listed: Drape KB100 Series, KD203, Kent Camera, SnapshotGLO, SnapshotNIR, SnapshotNIR (KD205)

Devices it lists

Device	Product code	Class	Role	Source
Autofluorescence Imaging Adjunct Tool For Wounds	QJF	2	Specification developer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Specification developer	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Manufacturer	accessdata.fda.gov
Tape, Camera, Surgical	FXN	1	Specification developer	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
March 26, 2025	K242669	SnapshotGLO (KB100)	QJF	Substantially Equivalent	Kent Imaging, Inc.	accessdata.fda.gov
April 2, 2024	K240601	SnapshotNIR model KD205	MUD	Substantially Equivalent	Kent Imaging, Inc.	accessdata.fda.gov
November 10, 2020	K201976	SnapshotNIR	MUD	Substantially Equivalent	Kent Imaging	accessdata.fda.gov
May 5, 2017	K163070	Kent Camera	MUD	Substantially Equivalent	Kent Imaging, Inc.	accessdata.fda.gov
August 8, 2012	K113507	KENT CAMERA	MUD	Substantially Equivalent	Kent Imaging, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 30, 2026	99406	Class II	Ongoing	SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.	The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.	accessdata.fda.gov
October 30, 2023	93624	Class II	Ongoing	Snapshot NIR, REF: KD204	Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.	accessdata.fda.gov

Compare with other makers

Updated July 22, 2026. 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.