510(k) Report

FDA applicant

Mri Devices Corp.

Waukesha, WI76 decisions1991–20059 recalls

FDA records 76 decisions for Mri Devices Corp. (Waukesha, WI) from 1991 to 2005: 76 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 19 predicates, 3 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “Mri Devices Corporation”.

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 Mri Devices Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mri Devices Corp. since 2007.

Recalls per year

7in 2024

2020: 22024: 7
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Mri Devices Corp.’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?

  • MOSCoil, Magnetic Resonance, Specialty65decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging10decisions
  • NEUMarker, Radiographic, Implantable1decision

Whose devices does it build on?

Its devices cite 19 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 60 times; 3 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.

  • K041286Dynacad V1.0Mri Devices Corp. · 20046cite it
  • K010570Breast Immobiization and Biopsy Device MR-Biopsy 160Mri Devices Corp. · 20016cite it
  • K013159HRH-63-8 Head Array CoilMri Devices Corp. · 20014cite it
  • K041481Model BBC-127 Biopsy Breast CoilMri Devices Corp. · 20044cite it
  • K032576Biopsy Breast Coil, Model BBCMri Devices Corp. · 20034cite it
  • K050622HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array CoilMri Devices Corporation · 20054cite it

What has FDA decided for it lately?

  • K050622HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array CoilMri Devices Corporation · 2005
  • K050621Nva-127-8-a Neurovascular Array CoilMri Devices Corporation · 2005
  • K050514Models Fac-63 and Fac-127 Foot and Ankle CoilsMri Devices Corporation · 2005
  • K050299HRK-123 Knee Array CoilMri Devices Corporation · 2005
  • K042103Nva-63-8-a and Nva-63-16-a Neurovascular Array CoilMri Devices Corporation · 2004
  • K041286Dynacad V1.0Mri Devices Corp. · 2004
  • K041481Model BBC-127 Biopsy Breast CoilMri Devices Corp. · 20041 recall
  • K040348Modification to HNC-127-Int Neurovascular Array CoilMri Devices Corp. · 2004

All 71 as Mri Devices Corp. →All 5 as Mri Devices Corporation →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K032576Achieva TX Interventional Coil 3.0TNov 4, 2024Class II
  • K032576dS Breast 7ch 1.5TNov 4, 2024Class II
  • K022488SENSE Breast CoilNov 4, 2024Class II
  • K032576Mammotrak Interventional Coil 1.5TNov 4, 2024Class II
  • K041481SENSE Breast Coil 3.0T 7chNov 4, 2024Class II
  • K024208ST SENSE Breast CoilNov 4, 2024Class II