510(k) Report

FDA applicant

Theta Systems, Inc.

Melbourne, FL2 decisions1991–19910 recalls

FDA records 2 decisions for Theta Systems, Inc. (Melbourne, FL) in 1991: 2 510(k) clearances. Most are in product codes IWB (System, Radiation Therapy, Radionuclide) and KPZ (Generator, High Voltage, X-Ray, Therapeutic). 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 Theta Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Theta Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Theta 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?

  • IWBSystem, Radiation Therapy, Radionuclide1decision
  • KPZGenerator, High Voltage, X-Ray, Therapeutic1decision

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K912250Isorad (TM) Integral Buildup Photon DiodesTheta Systems, Inc. · 19912cite it
  • K912249Patient Dose MonitorTheta Systems, Inc. · 19912cite it

What has FDA decided for it lately?

  • K912250Isorad (TM) Integral Buildup Photon DiodesTheta Systems, Inc. · 1991
  • K912249Patient Dose MonitorTheta Systems, Inc. · 1991

All 2 as Theta Systems, Inc. →