Electronic Ultrasound Scanner EUB-315, Modified

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

510(k) Number

K912364 ↗

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 EUB-315 Modified Ultrasound Scanner used for?

  The EUB-315 Modified Ultrasound Scanner is designed for diagnostic imaging in clinical settings. It generates real-time ultrasound images using high-frequency sound waves to visualize internal body structures, such as organs and tissues. This aids radiologists and sonographers in assessing potential abnormalities during evaluations, making it a key tool in radiology for conditions requiring cross-sectional imaging.

• Is the EUB-315 Modified a single-use or reusable device?

  The EUB-315 Modified is a reusable medical device. Since it is not sterile, it must be thoroughly cleaned and disinfected between uses following established infection control protocols to maintain safety and performance. Regular maintenance and calibration are also required to ensure accurate imaging results.

• What type of maintenance does the EUB-315 Modified require?

  As a reusable diagnostic imaging device, the EUB-315 Modified requires proper maintenance and calibration to sustain its imaging accuracy. This includes routine cleaning, disinfection, and technical checks to prevent degradation of performance. The manufacturer’s guidelines should be followed to ensure compliance with regulatory standards and optimal functionality.

• Does the EUB-315 Modified have any specific safety considerations for MRI environments?

  The available data does not specify an MRI safety classification for the EUB-315 Modified. If used in proximity to MRI equipment, caution should be exercised, and the device should be handled according to MRI-safe protocols to avoid interference or safety hazards. Always verify compatibility with the specific MRI system in use.

• What regulatory approval does the EUB-315 Modified hold in the United States?

  The EUB-315 Modified holds FDA 510(k) clearance (K912364) in the United States. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device under the Radiology advisory committee. It adheres to Class II imaging system regulations, ensuring it meets the necessary safety and performance standards for clinical use.