510(k) Report

FDA applicant

Emi Therapy Systems, Inc.

Mchenry, IL5 decisions1977–19780 recalls

FDA records 5 decisions for Emi Therapy Systems, Inc. (Mchenry, IL) from 1977 to 1978: 5 510(k) clearances. Most are in product codes JAD (System, Therapeutic, X-Ray) and IYE (Accelerator, Linear, Medical). 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 Emi Therapy Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emi Therapy Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JADSystem, Therapeutic, X-Ray2decisions
  • IYEAccelerator, Linear, Medical2decisions
  • IWBSystem, Radiation Therapy, Radionuclide1decision

What has FDA decided for it lately?

  • K781084Therapax 150AEmi Therapy Systems, Inc. · 1978
  • K780948System, Planning, TreatmentEmi Therapy Systems, Inc. · 1978
  • K780027Accelerator, Linear, Med.Emi Therapy Systems, Inc. · 1978
  • K771817Emi Therapy SimulatorEmi Therapy Systems, Inc. · 1978
  • K771902Emi FourEmi Therapy Systems, Inc. · 1977

All 5 as Emi Therapy Systems, Inc. →