510(k) Report

FDA applicant

Iris Remote Imaging Systems

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Iris Remote Imaging Systems (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code IBJ (Light, Microscope). 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, pathology panel, where it files most

How often FDA has decided Iris Remote Imaging Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iris Remote Imaging Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iris Remote Imaging Systems 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?

  • IBJLight, Microscope1decision

What has FDA decided for it lately?

  • K823040Pathology Instrumentation & AccessoriesIris Remote Imaging Systems · 1983

The one decision as Iris Remote Imaging Systems →

Other applicant names beginning “Iris”

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

Iris International, Inc. 3Iris Diagnostics 2Iris 1Iris International Inc., A Division of Iris Iris I 1Iris USA 1Iris Optical, Inc. 1Iris Molecular Diagnostics 1Iris Surgical, LLC 1Iris Medical Ent., Inc. 1Iris Diagnostics, A Division of Iris International, Inc. 1