Elite R/F Spot Film Drive

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K902403 ↗

FDA Product Code

IXL

Device Class

Class II

Regulation

21 CFR Part 892.1670

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Elite R/F Spot Film Drive used for in a clinical setting?

  The Elite R/F Spot Film Drive is an electromechanical component designed specifically for fluoroscopic X-ray systems. It positions radiographic film cassettes to capture high-contrast spot radiographs during fluoroscopic procedures, allowing clinicians to focus on and clearly image targeted anatomical regions for improved diagnostic accuracy.

• Is the Elite R/F Spot Film Drive intended for single-use or can it be reused?

  The Elite R/F Spot Film Drive is supplied as a reusable component for fluoroscopic systems. Since it is not sterile, proper cleaning and maintenance per manufacturer guidelines are required to ensure safe and effective reuse in radiology settings.

• How is the Elite R/F Spot Film Drive regulated and what does that mean for integration into existing systems?

  The Elite R/F Spot Film Drive holds an FDA 510(k) clearance (K902403) under the Spot-Film Device classification (product code: IXL). This means it has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safe integration into existing fluoroscopic X-ray systems.

• What types of fluoroscopic systems is the Elite R/F Spot Film Drive compatible with?

  The Elite R/F Spot Film Drive is designed as an electromechanical component for general fluoroscopic X-ray systems used in radiology. While the exact compatibility depends on system specifications, its classification as a Spot-Film Device (Class II) and regulatory clearance indicate it is intended for integration into standard fluoroscopic workflows to enhance targeted imaging.