510(k) Report

FDA applicant

Marconi Medical Systems, Inc.

Cleveland, OH2 decisions2000–200161 recalls

FDA records 2 decisions for Marconi Medical Systems, Inc. (Cleveland, OH) from 2000 to 2001: 2 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 2 predicates, 0 of them its own earlier devices. 61 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 Marconi Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2025

2007: 12008: 22009: 22010: 22011: 12012: 132013: 32014: 52015: 92016: 52018: 92021: 12025: 1
2007high 13 (2012) · low 0 (2017)2026

Class I Class II/III not classified

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

Planning a device like Marconi 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?

  • JAKSystem, X-Ray, Tomography, Computed2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 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.

  • K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 200111cite it

What has FDA decided for it lately?

  • K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 200161 recalls
  • K002005Boluspro UltraMarconi Medical Systems, Inc. · 2000

All 2 as Marconi Medical Systems, Inc. →

What has been recalled?

61 recalls linked to its devices; the latest:

  • K012009Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number…Aug 13, 2025Class II
  • K012009Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket…May 1, 2021Class II
  • K012009Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems…Oct 18, 2018Class II
  • K012009Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray…Oct 18, 2018Class II
  • K012009Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems…Oct 18, 2018Class II
  • K012009Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems…Oct 18, 2018Class II