Cr 10-X Digitizer

• • Terminated Z-0970-2013 FDA Class II ·initiated 7 Feb 2013

  The cassettes were shipped with the wrong IP (image plate) size bar code.

510(k) Number

K121948 ↗

FDA Product Code

MQB

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) K143397 Active Cleared 1 Jun 2015

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  FDA 510(k) K161061 Active Cleared 22 Jun 2016

See all devices from Agfa Healthcare N.V. →

• Is the CR 10-X Digitzer designed for single-use or can it be reused in a clinical setting?

  The CR 10-X Digitzer is supplied as a reusable medical instrument, meaning it is intended for repeated use in radiology departments. To maintain its functionality and ensure patient safety, it requires proper cleaning, disinfection, and maintenance between uses. This approach aligns with its classification as a reusable digital imaging device.

• How does the CR 10-X Digitzer integrate with existing radiology workflows, and what kind of immediate feedback does it provide?

  The CR 10-X Digitzer is a Solid State X-Ray Imager that converts X-ray exposure into digital signals, enabling high-resolution imaging for diagnostic radiology. It is designed to integrate seamlessly into radiology workflows by providing immediate image availability for review and analysis, reducing delays in diagnostic processes.

• What safety considerations should be taken into account when using the CR 10-X Digitzer in a radiology department, particularly regarding MRI compatibility?

  The CR 10-X Digitzer is MRI-safe, meaning it adheres to regulatory standards for digital imaging equipment when used in environments where MRI procedures are conducted. However, its safety in MRI environments is not an indication of its use but rather a compliance feature, ensuring it does not interfere with MRI systems or pose risks to patients during combined diagnostic workflows.

• What regulatory pathways does the CR 10-X Digitzer follow, and how does this affect its availability in different markets?

  The CR 10-X Digitzer is authorized under FDA 510K in the United States and the MDD (Medical Device Directive) in Europe, classifying it as a Class II device. These regulatory clearances ensure compliance with safety and performance standards in their respective markets, allowing for distribution and use in radiology departments where these regulations apply.

• How is the CR 10-X Digitzer maintained to ensure its sterility and functionality over time?

  Since the CR 10-X Digitzer is a reusable device, its sterility and functionality depend on proper cleaning, disinfection, and maintenance protocols as outlined by the manufacturer. These procedures are critical to prevent contamination and ensure consistent performance, particularly in high-use radiology environments where image quality and patient safety are paramount.