3.0 MHz Linear Array Probe Model UST 5031

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

510(k) Number

K860313 ↗

FDA Product Code

HGL

Device Class

Class II

Regulation

21 CFR Part 884.2960

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the 3.0 MHz Linear Array Probe Model UST 5031?

  The 3.0 MHz Linear Array Probe Model UST 5031 is designed specifically for obstetric and gynecological ultrasound imaging. It provides real-time, rectangular-field visualization of soft tissues and organs in the pelvic region, allowing clinicians to assess fetal development, placental positioning, and maternal anatomy during diagnostic ultrasound examinations.

• Is the UST 5031 probe supplied sterile, and how should it be handled?

  The UST 5031 probe is not sterile at the time of shipment. It is intended for reuse in clinical settings such as hospitals and obstetrics/gynecology clinics. Proper cleaning and reprocessing must be performed according to established infection control protocols to ensure safe and effective use.

• What type of device classification does the UST 5031 hold under FDA regulations?

  The 3.0 MHz Linear Array Probe Model UST 5031 is classified as a Class II medical device under FDA regulations (21 CFR 884.2960). This classification reflects its moderate risk level, requiring special controls to ensure safety and performance. It holds an FDA 510(k) clearance (K860313) for substantial equivalence.

• Are there any specific safety considerations for using this probe near MRI environments?

  The manufacturer does not provide specific MRI safety information for the UST 5031 probe. If used near MRI environments, users must follow the manufacturer’s guidelines for safe operation to avoid potential risks associated with magnetic fields.

• What frequency does the UST 5031 probe operate at, and why is this important?

  The UST 5031 probe operates at a frequency of 3.0 MHz, which is optimized for obstetric and gynecological imaging. This frequency provides a balance between image resolution and tissue penetration, allowing for detailed visualization of fetal structures and maternal anatomy during ultrasound examinations.