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Intl. Remote Imaging Systems

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Devices
14

What Intl. Remote Imaging Systems makes

The company manufactures urine analysis systems, including manual and automated urinalysis workstations with body fluid analysis capabilities, such as the Yellow Iris Urinalysis Workstation and its variants. It also produces urine pathology systems like the 939UDX and 900UDX, as well as urine stain reagents (e.g., IrisStain Formula 2) and cytopathology workstations (e.g., the Purple Iris). Control specimens for urinalysis, such as the IRI Spec Urinalysis Control, are also part of the portfolio.

These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

How many devices does Intl. Remote Imaging Systems have in the registry?

The registry currently lists 14 devices for Intl. Remote Imaging Systems. Devices recorded under merged duplicate company entries are counted once.

Which registries list Intl. Remote Imaging Systems's devices?

Among its 14 most recently registered devices, Intl. Remote Imaging Systems has devices listed in FDA 510(k) (14 devices).

What risk classes do Intl. Remote Imaging Systems's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Intl. Remote Imaging Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Intl. Remote Imaging Systems in the registry?

The most recently registered devices listed for Intl. Remote Imaging Systems include IRIS URINE STAIN, 939UDX URINE PATHOLOGY SYSTEM, THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY and IQ 200 SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.