510(k) Report

FDA applicant

Medicsight

London, GB6 decisions2003–20110 recalls

FDA records 6 decisions for Medicsight (London, GB) from 2003 to 2011: 6 510(k) clearances. Most are in product codes OEB (Lung Computed Tomography System…) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 13 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medicsight Plc”.

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

FDA decisions per year

1in 2011

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medicsight’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?

  • OEBLung Computed Tomography System, Computer-Aided Detection2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • NWEColon Computed Tomography System, Computer Aided Detection2decisions

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K042674Colon Car 1.2Medicsight · 20043cite it
  • K041807Lung Car 1.1Medicsight · 20041cites it
  • K033412Mediclung, Release 1Medicsight · 20031cites it
  • K033102Medic Colon Model, Release 1Medicsight · 20031cites it
  • K083423Coloncad Api 3.1Medicsight Plc · 20111cites it

What has FDA decided for it lately?

  • K083423Coloncad Api 3.1Medicsight Plc · 2011
  • K042674Colon Car 1.2Medicsight · 2004
  • K041807Lung Car 1.1Medicsight · 2004
  • K033412Mediclung, Release 1Medicsight · 2003
  • K032823Medicheart, Model Release 1Medicsight · 2003
  • K033102Medic Colon Model, Release 1Medicsight · 2003

All 5 as Medicsight →The one decision as Medicsight Plc →