510(k) Report

FDA applicant

Inner Vision Biometrics Pty, Ltd.

Claremont, Perth, AU1 decision2005–20050 recalls

FDA records 1 decision for Inner Vision Biometrics Pty, Ltd. (Claremont, Perth, AU) in 2005: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 0 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 Inner Vision Biometrics Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inner Vision Biometrics Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inner Vision Biometrics Pty, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inner Vision Biometrics Pty, 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

Other applicant names beginning “Inner”

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