FDA applicant

Micro-X, Ltd.

Tonsley (Clovelly Park), AU2 decisions2020–202110 recalls

FDA records 2 decisions for Micro-X, Ltd. (Tonsley (Clovelly Park), AU) from 2020 to 2021: 2 510(k) clearances. All are in product code IZL (System, X-Ray, Mobile). Its devices cite 2 predicates, 1 of them its own earlier devices. 10 recalls are linked to its devices.

FDA’s records also spell it “Micro-X Limited”.

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 Micro-X, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2026

2020high 4 (2025) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Micro-X, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micro-X, Ltd.’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

Micro-X, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?