FDA applicant

Kent Imaging, Inc.

Calgary, CA5 decisions2012–20252 recalls

FDA records 5 decisions for Kent Imaging, Inc. (Calgary, CA) from 2012 to 2025: 5 510(k) clearances. Most are in product codes MUD (Oximeter, Tissue Saturation) and QJF (Autofluorescence Imaging Adjunct Tool For Wounds). Its devices cite 5 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Kent Imaging”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Kent Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2026

2012high 1 (2023) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Kent Imaging, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kent Imaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Kent”

FDA records each applicant name separately; these may or may not be the same firm.

Kent Laboratories, Inc. 40 Kent Design & Manufacturing, Inc. 6 Kent Barker & Assoc. 1 Kent J. Toone, D.D.S. 1 Kent Medical Devices, Inc. 1

Kent Imaging, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Kent”