510(k) Report

FDA applicant

Burdette Medical Systems, Inc.

Champaign, IL1 decision1999–19991 recall

FDA records 1 decision for Burdette Medical Systems, Inc. (Champaign, IL) in 1999: 1 510(k) clearance. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 Burdette Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burdette Medical Systems, Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Burdette Medical Systems, 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

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K982696InterplantBurdette Medical Systems, Inc. · 19991cites it

What has FDA decided for it lately?

  • K982696InterplantBurdette Medical Systems, Inc. · 19991 recall

The one decision as Burdette Medical Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K982696Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 Used when…Dec 1, 2008