Deluxe Adjustable Height Ultrasound Table

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

510(k) Number

K922604 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Deluxe Adjustable Height Ultrasound Table designed for?

  This table is specifically engineered to support patients during ultrasound imaging procedures. Its adjustable height and positioning features accommodate various patient sizes and examination needs, ensuring stability and comfort while allowing optimal access for ultrasound transducers and equipment. This design helps reduce operator strain during prolonged procedures, making it ideal for radiology departments and clinical imaging settings.

• Is the Deluxe Adjustable Height Ultrasound Table reusable or single-use?

  The table is designed as a reusable medical device. It is non-sterile and requires routine cleaning and maintenance between uses to maintain hygiene and functionality. This approach aligns with its intended use in clinical settings where multiple patients may be accommodated over time.

• What regulatory clearance does the Deluxe Adjustable Height Ultrasound Table hold?

  The table has received FDA 510(k) clearance under the Radiology Advisory Committee (RA) in 1992, with clearance number K922604. This classification confirms it is substantially equivalent to a legally marketed device and adheres to FDA regulatory standards for ultrasound examination tables.

• How should the Deluxe Adjustable Height Ultrasound Table be stored?

  Storage should follow the manufacturer’s guidelines to preserve the table’s functionality and ensure patient safety. Proper storage conditions will likely include keeping the table in a clean, dry environment, away from direct sunlight or extreme temperatures, and protecting it from physical damage or excessive weight.

• Does the Deluxe Adjustable Height Ultrasound Table have any MRI safety classification?

  The regulatory submission for this device does not specify an MRI safety classification. If MRI compatibility is required for your facility, additional verification or documentation from the manufacturer may be necessary to ensure safe use in an MRI environment.