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Bio-Scan S.A

Country not established

Devices
1

What Bio-Scan S.A makes

Bio-Scan S.A. manufactures solid-state X-ray imaging devices, including the IRIS 20 and IRIS 41 models with the IRIS View software interface. These devices are designed for portable or fixed medical imaging applications, providing digital radiographic capabilities for diagnostic use.

The company’s imaging devices fall under FDA Class II regulation and are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.

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

Catalogue1

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Frequently asked questions

How many devices does Bio-Scan S.A have in the registry?

The registry currently lists 1 device for Bio-Scan S.A. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bio-Scan S.A's devices?

Among its 1 most recently registered device, Bio-Scan S.A has devices listed in FDA 510(k) (1 device).

What risk classes do Bio-Scan S.A's devices fall under?

Among its 1 most recently registered device, the classes recorded for Bio-Scan S.A's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bio-Scan S.A in the registry?

The most recently registered devices listed for Bio-Scan S.A include SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW.

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