FDA applicant

Imex Medical Systems, Inc.

Golden, CO19 decisions1983–19980 recalls

FDA records 19 decisions for Imex Medical Systems, Inc. (Golden, CO) from 1983 to 1998: 19 510(k) clearances. Most are in product codes JOP (Transducer, Ultrasonic) and JAF (Monitor, Ultrasonic, Nonfetal). 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 Imex Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Imex Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Imex Medical Systems, 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 “Imex”

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

Imex Health, Inc. 1 Imex 1

Imex Medical Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Imex”