FDA applicant

Resonance Health Analysis Services Pty, Ltd.

Perth, AU7 decisions2011–20230 recalls

FDA records 7 decisions for Resonance Health Analysis Services Pty, Ltd. (Perth, AU) from 2011 to 2023: 6 510(k) clearances and 1 De Novo grant. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and PCS (Liver Iron Concentration Imaging Companion…). Its devices cite 10 predicates, 6 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 Resonance Health Analysis Services Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Resonance Health Analysis Services Pty, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Resonance”

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

Resonance Innovations, LLC 8 Resonance Technology, Inc. 1

Resonance Health Analysis Services Pty, 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?

Other applicant names beginning “Resonance”