510(k) Report

FDA applicant

Our Scientific Intl., Inc.

Pleasanton, CA2 decisions1997–19990 recalls

FDA records 2 decisions for Our Scientific Intl., Inc. (Pleasanton, CA) from 1997 to 1999: 2 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and IWB (System, Radiation Therapy, Radionuclide). Its devices cite 1 predicate, 0 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 Our Scientific Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Our Scientific Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Our Scientific Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment1decision
  • IWBSystem, Radiation Therapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K970647Our Rotating Gamma SystemOur Scientific Intl., Inc. · 19972cite it

What has FDA decided for it lately?

  • K991815Explorer 3DOur Scientific Intl., Inc. · 1999
  • K970647Our Rotating Gamma SystemOur Scientific Intl., Inc. · 1997

All 2 as Our Scientific Intl., Inc. →