510(k) Report

FDA applicant

Radiomed Corporation

Tyngsboro, MA7 decisions2000–20170 recalls

FDA records 7 decisions for Radiomed Corporation (Tyngsboro, MA) from 2000 to 2017: 7 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and IYE (Accelerator, Linear, Medical). Its devices cite 12 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Radiomed Corp.”.

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 Radiomed Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12012: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Radiomed Corporation’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?

  • KXKSource, Brachytherapy, Radionuclide3decisions
  • IYEAccelerator, Linear, Medical2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 6 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.

  • K070305Pre-Loaded VisicoilRadiomed Corporation · 20076cite it
  • K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 20034cite it
  • K013660GenetraRadiomed Corporation · 20012cite it
  • K001070Radiomed SourceRadiomed Corp. · 20002cite it
  • K022326Radiomed MarkerRadiomed Corporation · 20031cites it
  • K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation · 20171cites it

What has FDA decided for it lately?

  • K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Radiomed Corporation · 2017
  • K120859Pre-Loaded Gold Visicoil CK MarkerRadiomed Corporation · 2012
  • K070305Pre-Loaded VisicoilRadiomed Corporation · 2007
  • K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
  • K022326Radiomed MarkerRadiomed Corporation · 2003
  • K013660GenetraRadiomed Corporation · 2001
  • K001070Radiomed SourceRadiomed Corp. · 2000

All 5 as Radiomed Corporation →All 2 as Radiomed Corp. →