Lateral Angulating Fluoro Suspension System

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

Full name

Lateral Angulating Fluoro Suspension Sys

510(k) Number

K812561 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Lateral Angulating Fluoro Suspension System used for?

  The Lateral Angulating Fluoro Suspension System is a Class II fluoroscopy system designed for use in radiology procedures. It functions as an X-ray, fluoroscopic, image-intensified system that allows for lateral angulation during fluoroscopic imaging procedures.

• How is the Lateral Angulating Fluoro Suspension System supplied?

  The device is supplied as a complete system. The device data does not specify whether it is single-use or reusable, indicating it should be used according to the manufacturer's instructions and facility protocols.

• What is the regulatory status of the Lateral Angulating Fluoro Suspension System?

  The system has FDA 510(k) clearance with K-number K812561 and product code JAA. It is regulated under 21 CFR 892.1650 and was first cleared on October 13, 1981. The device is classified as substantially equivalent.

• Are there different models or sizes of the Lateral Angulating Fluoro Suspension System?

  The device data lists multiple FEI numbers associated with this device model, suggesting there may be different configurations or variations of the system available. However, specific size information or model distinctions are not provided in the device data.