510(k) Report

FDA applicant

Alltech Medical Systems America, Inc.

Solon, OH4 decisions2008–20171 recall

FDA records 4 decisions for Alltech Medical Systems America, Inc. (Solon, OH) from 2008 to 2017: 4 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 3 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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 Alltech Medical Systems America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12012: 12015: 12017: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1, 1 Class I
2008high 1 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Alltech Medical Systems America, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging4decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082100Alltech Echostar 1.5 T MR SystemAlltech Medical Systems America, Inc. · 20081cites it
  • K113511Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 20121cites it
  • K141945Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 20151cites it

What has FDA decided for it lately?

  • K163192Comfort EC710Alltech Medical Systems America, Inc. · 2017
  • K141945Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc. · 2015
  • K113511Echostar Spica 1.5T MR SystemAlltech Medical Systems America, Inc. · 20121 Class I recall
  • K082100Alltech Echostar 1.5 T MR SystemAlltech Medical Systems America, Inc. · 2008

All 4 as Alltech Medical Systems America, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K113511Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.Jan 9, 2015Class I