510(k) Report

FDA applicant

Fmi Medical Systems, Inc.

Solon, OH2 decisions2018–20200 recalls

FDA records 2 decisions for Fmi Medical Systems, Inc. (Solon, OH) from 2018 to 2020: 2 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 3 predicates, 1 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 Fmi Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Fmi Medical Systems, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173076CURA 16; ScintCare CT16Fmi Medical Systems, Inc. · 20181cites it

What has FDA decided for it lately?

  • K192590CURA 778Fmi Medical Systems, Inc. · 2020
  • K173076CURA 16; ScintCare CT16Fmi Medical Systems, Inc. · 2018

All 2 as Fmi Medical Systems, Inc. →