510(k) Report

FDA applicant

Permedics, Inc.

Irvine, CA2 decisions2000–20052 recalls

FDA records 2 decisions for Permedics, Inc. (Irvine, CA) from 2000 to 2005: 2 510(k) clearances. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are 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 Permedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Permedics, Inc. since 2007.

Recalls per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K993895OptiradPermedics, Inc. · 20002cite it
  • K042861OdysseyPermedics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K042861OdysseyPermedics, Inc. · 20052 recalls
  • K993895OptiradPermedics, Inc. · 2000

All 2 as Permedics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K042861Odyssey A radiation treatment planning systemNov 4, 2010
  • K042861Odyssey Intended use: Radiation treatment planning systemMar 23, 2010