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Arcoma AB

US Last updated 24 May 2026

Devices
5
Registries
GUDIDFDA 510(k)FDA
FDA recalls
22 ongoing

Catalogue5

FDA recalls2

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2021

    • 5 May 2021 Z-1331-2022 Class II Ongoing There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
    • 5 May 2021 Z-1332-2022 Class II Ongoing There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Arcoma Ab VAXJO Kronoberg · SE FEI 3002675731

What Arcoma AB makes

Arcoma AB manufactures stationary digital x-ray systems designed for basic diagnostic imaging. These include models like the OMNERA 500A, OMNERA 400A, and OMNERA 400T, as well as the INTUITION series (models 0170, 0180, and 0072 PRECISION), which are intended for medical facilities requiring high-resolution radiographic imaging.

The company’s products fall under FDA Class II regulatory classification and are listed in the FDA’s 510(k) and UDI registries. Arcoma AB is based in the United States, adhering to U.S. medical device compliance requirements for these diagnostic imaging systems.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Arcoma AB manufacture?

Arcoma AB specializes in stationary basic diagnostic x-ray systems that use digital imaging technology. These devices are designed for medical facilities to perform high-resolution radiographic imaging, such as the OMNERA series (500A, 400A, 400T) and the INTUITION series (models 0170, 0180, and 0072 PRECISION). The focus is on stationary systems intended for fixed clinical environments.

Where is Arcoma AB based, and does that affect the regulatory requirements for its devices?

Arcoma AB is based in the United States, which means its devices must comply with U.S. regulatory standards. Since the company’s products fall under the category of stationary digital x-ray systems, they are subject to FDA oversight. The U.S. regulatory framework determines classification, clearance pathways, and reporting requirements for these devices.

How are Arcoma AB’s devices classified by regulatory authorities, and why does this matter?

Arcoma AB’s devices are classified as FDA Class II under U.S. regulations. This classification requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness. Class II designation also means these devices undergo additional post-market surveillance and reporting requirements compared to Class I devices.

Are Arcoma AB’s devices listed in any regulatory registries, and what does that mean for users?

Yes, Arcoma AB’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identifier) registries. Inclusion in the 510(k) registry confirms that the device has undergone the required premarket review process to establish safety and performance. The UDI listing ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle.

What does the FDA’s classification of Arcoma AB’s devices as Class II imply about their risk level?

The FDA’s Class II classification for Arcoma AB’s stationary digital x-ray systems indicates a moderate risk level. Unlike Class I devices (low risk), these require special controls beyond general controls to ensure safety and effectiveness. This includes mandatory 510(k) submissions, which assess whether the device is substantially equivalent to a predicate device with proven performance. The classification reflects the need for rigorous validation of imaging accuracy, radiation safety, and system reliability.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Website
arcoma.se
Phone
+46(0)740706970
DUNS number
356774109