510(k) Report

FDA applicant

Intelligent Images Srl

Genova (Ge), IT2 decisions2002–20040 recalls

FDA records 2 decisions for Intelligent Images Srl (Genova (Ge), IT) from 2002 to 2004: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 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 Intelligent Images Srl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intelligent Images Srl since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intelligent Images Srl 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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K022940IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 20022cite it
  • K041581Compacs, Version 1.0Intelligent Images Srl · 20041cites it

What has FDA decided for it lately?

  • K041581Compacs, Version 1.0Intelligent Images Srl · 2004
  • K022940IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl · 2002

All 2 as Intelligent Images Srl →

Other applicant names beginning “Intelligent”

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

Intelligent Hearing Systems 13Intelligent Implant Systems, LLC 6Intelligent Medical Devices, Inc. 4Intelligent Medicine, Inc. 4Intelligent Orthopaedics, Ltd. 3Intelligent Medical Systems 2Intelligent Ultrasound Limited 2Intelligent Surgical Lasers, Inc. 2Intelligent Product Limited Co. 2Intelligent Software Systems, Inc. 1Intelligent Sensory Concept SA 1Intelligent Medica Imaging, Inc. 1