510(k) Report

FDA applicant

Medic Vision - Imaging Solutions, Ltd.

Tirat Carmel, IL2 decisions2016–20180 recalls

FDA records 2 decisions for Medic Vision - Imaging Solutions, Ltd. (Tirat Carmel, IL) from 2016 to 2018: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medic Vision Imaging Solutions”.

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 Medic Vision - Imaging Solutions, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Medic Vision - Imaging Solutions, Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medic Vision - Imaging Solutions, 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?

  • LLZSystem, Image Processing, Radiological1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision

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 1 time; 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.

  • K153331SafeCT-29Medic Vision Imaging Solutions · 20161cites it

What has FDA decided for it lately?

  • K173605iQMRMedic Vision - Imaging Solutions, Ltd. · 2018
  • K153331SafeCT-29Medic Vision Imaging Solutions · 2016

The one decision as Medic Vision - Imaging Solutions, Ltd. →The one decision as Medic Vision Imaging Solutions →

Other applicant names beginning “Medic”

FDA records each applicant name separately; these may or may not be the same firm.

Medic, Inc. 12Medic-Aid, Ltd. 9Medic Sharplight, Ltd. 1Medic One 1Medic Vision Brain Technologies, Ltd. 1Medic Group of Scandinavia, Inc. 1Medic Evaluation Devices & Instruments Corp. 1