510(k) Report

FDA applicant

Instrumentarium Imaging, Inc.

Milwaukee, WI24 decisions1989–20001 recall

FDA records 24 decisions for Instrumentarium Imaging, Inc. (Milwaukee, WI) from 1989 to 2000: 24 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and IZH (System, X-Ray, Mammographic). 1 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 Instrumentarium Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instrumentarium Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Instrumentarium Imaging, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Instrumentarium”

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