DX-D 300

510(k) Number

K103050 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K161061 Active Cleared 22 Jun 2016

See all devices from Agfa Healthcare N.V. →

• Is the DX-D 300 system designed for single-use or can it be reused in a clinical setting?

  The DX-D 300 is explicitly described as a reusable stationary X-ray system. Since it is classified as a Class II medical device and requires proper calibration and maintenance per manufacturer instructions, it is intended for repeated use in radiology departments rather than single-use applications.

• What types of radiographic imaging applications is the DX-D 300 system intended for?

  The DX-D 300 is a multipurpose digital radiography system, meaning it is designed for general radiographic imaging tasks in radiology settings. Its fully motorized detector system ensures consistent visualization and contrast, making it suitable for a broad range of diagnostic purposes, though the exact clinical indications are not specified in the data.

• How is the DX-D 300 system regulated, and what does that mean for its use in hospitals?

  The DX-D 300 holds FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and performance. This means it has undergone evaluation by the FDA as substantially equivalent to a predicate device and is authorized for use in radiology departments in the U.S. under standard medical device regulations. Hospitals must adhere to manufacturer guidelines for installation, calibration, and maintenance.

• Does the DX-D 300 system come in multiple sizes or configurations, or is it available in only one model?

  The DX-D 300 is supplied in a single configuration, identified as Model 300. There are no variations or additional sizes listed in the provided data, indicating it is a unified system designed for standard radiographic imaging needs.

• What safety considerations should be taken into account when using the DX-D 300 in a radiology department?

  The DX-D 300 operates within standard MRI safety guidelines for non-MRI environments, meaning it is not intended for use inside MRI rooms but is safe for general radiology settings. Proper calibration, maintenance, and adherence to manufacturer instructions are required to ensure safe and effective operation, as the system is not self-calibrating or automated beyond its built-in processing capabilities.