AX Workstation DR-Viewer Software Option

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

510(k) Number

K992925 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K781286 Active Cleared 11 Sep 1978

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  Class I

  FDA 510(k) K820112 Active Cleared 24 Feb 1982

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• What types of medical images can the AX Workstation DR-Viewer Software Option process and analyze?

  The AX Workstation DR-Viewer Software Option is designed to process radiographic, fluoroscopic, and angiographic X-ray images specifically of the spine, legs, or colon. It reconstructs multiple input images into a single composite format, allowing physicians to view and analyze these combined images for diagnostic purposes.

• How is the AX Workstation DR-Viewer Software Option supplied and integrated into the system?

  The software option is supplied as part of the AX Workstation system and is loaded directly onto it. It is not a standalone device but an accessory that enhances the workstation’s capabilities by enabling image reconstruction and analysis tools for radiographic, fluoroscopic, or angiographic studies.

• What kind of measurement and analysis tools does the software provide for physicians?

  The AX Workstation DR-Viewer Software Option includes post-processing tools that allow physicians to apply measurements and further analyze the reconstructed composite images. These tools help in evaluating the combined radiographic, fluoroscopic, or angiographic data for improved diagnostic accuracy.

• Is the AX Workstation DR-Viewer Software Option intended for single-use or repeated use in clinical settings?

  The AX Workstation DR-Viewer Software Option is not a consumable device like a single-use item. Since it is a software option loaded onto the AX Workstation, it is designed for repeated use in clinical settings, enabling continuous processing and analysis of X-ray images over time.

• What was the regulatory pathway and classification for the FDA clearance of this software option?

  The AX Workstation DR-Viewer Software Option received FDA clearance through a traditional 510(k) review process under the product code LLZ, classified under the Radiology advisory committee (RA). The clearance was granted as substantially equivalent to a predicate device, with the submission filed in 1999 and decided on November 23, 1999.