Kodak DirectView CR Mammography Feature

• • Terminated Z-0820-2015 FDA Class II ·initiated 30 Oct 2014 ·on shared PMA P080018

  Reduced mammographic image quality when attempting to print true size multi-format images

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Kodak Directview Computed Radiography (Cr) Mammography

Generic Name

Full field digital, system, x-ray, mammographic

PMA Number

P080018 ↗

FDA Product Code

MUE

Device Class

Class II

Regulation

21 CFR Part 892.1715

Advisory Committee

Radiology

FDA Decision

APRL

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• What clinical applications does the Kodak DirectView CR Mammography Feature support, and how does it compare to traditional screen-film systems?

  The Kodak DirectView CR Mammography Feature is designed for breast cancer screening and diagnosis, producing high-resolution digital mammographic images. It replicates the diagnostic capabilities of traditional screen-film systems, allowing images to be interpreted by qualified physicians on either hardcopy film or softcopy workstations. This means it serves the same clinical purposes as conventional mammography but leverages digital technology for enhanced workflow and image analysis.

• Is the Kodak DirectView CR Mammography Feature a standalone device, or does it require integration with other equipment?

  The Kodak DirectView CR Mammography Feature is not a standalone device. It is supplied as a component of the Kodak DirectView CR System and must be used in conjunction with a compatible mammographic X-ray machine to generate digital mammographic images. This integration ensures proper functionality for breast cancer screening and diagnosis.

• How is the Kodak DirectView CR Mammography Feature supplied, and what should I consider regarding its reuse or sterility?

  The Kodak DirectView CR Mammography Feature is part of the Kodak DirectView CR System and is not single-use. The cassettes and imaging plates used with this system may be reusable, but reuse depends on the manufacturer’s guidelines. Since this is a digital imaging feature—not a disposable or sterile component—sterility is not applicable to the device itself, but proper handling and cleaning of reusable parts should follow established protocols.

• What regulatory pathway was followed for the approval of this device, and what classification does it hold?

  The Kodak DirectView CR Mammography Feature was approved under the FDA’s Premarket Approval (PMA) pathway, with the PMA number P080018. It is classified as a Device Class 2 under FDA regulation number 892.1715, indicating it has a moderate level of risk and requires premarket approval to ensure safety and effectiveness.

• Does this device have any specific MRI safety information, or is it safe to use in environments with MRI equipment?

  The provided data does not include any MRI safety information for the Kodak DirectView CR Mammography Feature. If MRI compatibility is a concern in your facility, you should verify whether the device or its components could pose risks in an MRI environment, as this information is not explicitly addressed in the available documentation.