Kodak Directview Cr Cassette/Gp/15 X 30 Cm, Catalog# 8418253

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040378 ↗

FDA Product Code

IXA

Device Class

Class II

Regulation

21 CFR Part 892.1850

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• Is this cassette designed for single-use or reusable applications, and what maintenance is required?

  This cassette is explicitly designed for reusable applications in computed radiography (CR) imaging. Since it houses a storage phosphor screen, it must be manually cleaned and handled according to the manufacturer’s guidelines to ensure proper function and image quality. It is not sterile, so it should only be used in a controlled radiology environment where contamination risks are managed.

• What are the key dimensions and compatibility considerations for this cassette, and how does it integrate with Kodak’s systems?

  The cassette measures 15 cm by 30 cm, making it suitable for general radiology and dental panoramic imaging. It is specifically designed for compatibility with Kodak’s CR scanner systems, ensuring seamless digital conversion of X-ray exposures captured by its storage phosphor screen. The catalog number 8418253 helps identify the correct model for ordering and integration.

• How does this device differ from traditional radiographic film cassettes, and what imaging modalities does it support?

  Unlike traditional radiographic film cassettes, this Kodak DirectView CR Cassette uses a storage phosphor screen to capture latent images digitally, eliminating the need for chemical processing. It supports computed radiography (CR) imaging for general radiology and dental panoramic studies, providing high-resolution diagnostic outputs via laser scanning—unlike conventional film-based systems.

• What regulatory pathway was followed for this device, and what does the FDA’s classification mean for its use?

  This device followed the FDA’s 510(k) Traditional pathway, classified as Class II under the Radiology advisory committee (K040378). The