Xenon Gas Breathing Circuit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K952223 ↗

FDA Product Code

IYT

Device Class

Class II

Regulation

21 CFR Part 892.1390

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Xenon Gas Breathing Circuit used for?

  The Xenon Gas Breathing Circuit is a system designed for rebreathing radionuclide procedures in radiology, enabling the delivery and recovery of xenon gas during diagnostic imaging studies involving pulmonary function or cerebral blood flow assessments.

• How is the Xenon Gas Breathing Circuit supplied and is it reusable?

  The device is supplied as a complete breathing circuit system intended for use in clinical settings; however, the provided data does not specify whether it is single-use or reusable, so users must consult the manufacturer's labeling for reprocessing instructions and intended use limits.

• What regulatory pathway was used for the Xenon Gas Breathing Circuit?

  The Xenon Gas Breathing Circuit received FDA 510(k) clearance under submission K952223 on August 11, 1995, demonstrating substantial equivalence to a legally marketed predicate device under regulation 892.1390 for Class II radionuclide rebreathing systems.