510(k) Report

FDA applicant

Ml Strategies, Inc.

Boston, MA4 decisions1995–19981 recall

FDA records 4 decisions for Ml Strategies, Inc. (Boston, MA) from 1995 to 1998: 4 510(k) clearances. Most are in product codes IWI (Source, Isotope, Sealed, Gold, Titanium…) and KXK (Source, Brachytherapy, Radionuclide). 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 Ml Strategies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ml Strategies, Inc. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ml Strategies, 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?

  • IWISource, Isotope, Sealed, Gold, Titanium, Platinum1decision
  • KXKSource, Brachytherapy, Radionuclide1decision
  • LLZSystem, Image Processing, Radiological1decision
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K972271North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-aMl Strategies, Inc. · 19975cite it

What has FDA decided for it lately?

  • K983401Framewave WebMl Strategies, Inc. · 19981 recall
  • K973363North American Scientific (Nasi)PD-103 Radionuclide Brachytherapy Source-Model MED3633Ml Strategies, Inc. · 1998
  • K972271North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-aMl Strategies, Inc. · 1997
  • K950354Human Chorionic Gonadotropin (HCG) Test System for the Early Detection of PregnancyMl Strategies, Inc. · 1995

All 4 as Ml Strategies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K983401Fusion Workstation.; Indicated for the transmission and review of radiological images.Oct 28, 2011Class II