510(k) Report

FDA applicant

Activiews, Ltd.

Washington, DC3 decisions2011–20120 recalls

FDA records 3 decisions for Activiews, Ltd. (Washington, DC) from 2011 to 2012: 3 510(k) clearances. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 5 predicates, 3 of them its own earlier devices. No 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 Activiews, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 22012: 1
2011high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Activiews, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Activiews, Ltd.’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, Computed3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110812CT-Guide Needle Guidance SystemActiviews, Ltd. · 20112cite it
  • K113063CT-Guide Needle Guidance SystemActiviews, Ltd. · 20111cites it

What has FDA decided for it lately?

  • K120300CT-Guide Needle Guidance SystemActiviews, Ltd. · 2012
  • K113063CT-Guide Needle Guidance SystemActiviews, Ltd. · 2011
  • K110812CT-Guide Needle Guidance SystemActiviews, Ltd. · 2011

All 3 as Activiews, Ltd. →