510(k) Report

FDA applicant

Shai Syg Motion and Innovations, Ltd.

Efrat, IL2 decisions1996–19970 recalls

FDA records 2 decisions for Shai Syg Motion and Innovations, Ltd. (Efrat, IL) from 1996 to 1997: 2 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and JQP (Calculator/Data Processing Module, For…). 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 Shai Syg Motion and Innovations, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shai Syg Motion and Innovations, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic1decision
  • JQPCalculator/Data Processing Module, For Clinical Use1decision

What has FDA decided for it lately?

  • K964460The RoboliteShai Syg Motion and Innovations, Ltd. · 1997
  • K961849The RoboguideShai Syg Motion and Innovations, Ltd. · 1996

All 2 as Shai Syg Motion and Innovations, Ltd. →