Cr 12-X Digitizer

510(k) Number

K131408 ↗

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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See all devices from Agfa Healthcare N.V. →

• What is the primary purpose of the CR 12-X Digitzer in a clinical setting?

  The CR 12-X Digitzer is a Solid State X-Ray Imager (Flat Panel/Digital Imager) designed to capture and digitize radiographic images for diagnostic radiology. It converts X-ray exposure into electronic signals, enabling immediate visualization of internal structures for medical assessment, which is essential for accurate diagnosis and treatment planning.

• Is the CR 12-X Digitzer reusable or single-use, and what does this mean for maintenance?

  The CR 12-X Digitzer is reusable, meaning it is intended for repeated use in radiology settings. Since it is not single-use, proper calibration, maintenance, and storage as outlined by the manufacturer are required to ensure consistent imaging performance and prevent degradation over time.

• What regulatory pathways has the CR 12-X Digitzer followed, and what does this indicate about its compliance?

  The CR 12-X Digitzer holds FDA 510K clearance and complies with the MDD (Medical Device Directive). These pathways confirm that the device meets regulatory standards for safety and effectiveness in its intended use as a Solid State X-Ray Imager, ensuring it can be legally marketed and used in radiology environments.

• Are there different models or sizes available for the CR 12-X Digitzer, or is it a fixed configuration?

  The CR 12-X Digitzer is supplied as a fixed model configuration, meaning there is only one version (CR 12-X) available. No additional sizes or variants are mentioned in the provided data, so it is designed for general radiographic imaging without customization options.

• Can the CR 12-X Digitzer be used in an MRI environment, or are there any safety concerns?

  The CR 12-X Digitzer is not classified as MRI-safe, meaning it should not be used in or near an MRI environment. This is explicitly stated in the device description, as its design is tailored for standard radiographic settings rather than magnetic resonance compatibility.