510(k) Report

FDA applicant

Radiaction, Ltd.

Tel Aviv, IL3 decisions2022–20260 recalls

FDA records 3 decisions for Radiaction, Ltd. (Tel Aviv, IL) from 2022 to 2026: 3 510(k) clearances. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 1 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 Radiaction, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2022: 22026 (partial year): 1
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Radiaction, Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radiaction, 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?

  • OWBInterventional Fluoroscopic X-Ray System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 157 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 2 of its 3 were faster than that.

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222625Shield SystemRadiaction, Ltd. · 20221cites it

What has FDA decided for it lately?

  • K260607Shield System (Siemens 30x40)Radiaction, Ltd. · 2026
  • K222625Shield SystemRadiaction, Ltd. · 2022
  • K212159Shield SystemRadiaction, Ltd. · 2022

All 3 as Radiaction, Ltd. →