FDA applicant

Perimeter Medical Imaging, Inc.

Toronto, CA3 decisions2016–20190 recalls

FDA records 3 decisions for Perimeter Medical Imaging, Inc. (Toronto, CA) from 2016 to 2019: 3 510(k) clearances. All are in product code NQQ (System, Imaging, Optical Coherence Tomography…). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

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

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

FDA decisions per year

1in 2019

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Perimeter Medical Imaging, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Perimeter Medical 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 “Perimeter”

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

Perimeter Medical, Inc. 5 Perimeter Medical Imaging Ai, Inc. 2

Perimeter Medical 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?

Other applicant names beginning “Perimeter”