Acuson V714OR Transducer

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

510(k) Number

K921341 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Acuson V714OR Transducer used for?

  The Acuson V714OR Transducer is a diagnostic ultrasonic device intended for use in radiology imaging systems. It converts electrical signals into ultrasonic waves and vice versa, enabling clinicians to visualize internal body structures through ultrasound technology. This transducer is specifically designed for integration with ultrasound machines to support diagnostic imaging procedures in clinical settings.

• Is the Acuson V714OR Transducer single-use or reusable?

  The Acuson V714OR Transducer is supplied as a reusable component for ultrasound machines. Unlike single-use devices, this transducer is intended for repeated use in clinical radiology settings, provided it undergoes proper handling, maintenance, and cleaning to ensure optimal performance and imaging quality.

• What regulatory clearance does the Acuson V714OR Transducer hold?

  The Acuson V714OR Transducer holds an FDA 510(k) clearance (K921341), granted in 1992 under the Radiology advisory committee. It is classified as Class II with special controls and is determined to be substantially equivalent to a legally marketed predicate device. The clearance was issued through a traditional review process.

• How should the Acuson V714OR Transducer be stored?

  While the provided data does not specify storage conditions explicitly, reusable medical devices like the Acuson V714OR Transducer generally require clean, dry storage in a protected environment to prevent damage or contamination. Manufacturers typically recommend following their guidelines for maintenance, cleaning, and storage to ensure longevity and optimal performance.

• What product code category does the Acuson V714OR Transducer fall under?

  The Acuson V714OR Transducer is classified under product code ITX in the FDA’s regulatory framework. This classification is used for diagnostic ultrasound imaging devices, distinguishing it from other categories of medical imaging equipment.