Image Scanning Type Sonolay SAL-10A

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

510(k) Number

K771291 ↗

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 type of medical facility or department would typically use this device, and why is it suited for that environment?

  This device, the IMAGE SCANNING TYPE SONOLAY SAL-10A, is designed for radiology departments within hospitals or diagnostic imaging centers. It is a pulsed-echo ultrasonic imaging system, meaning it generates high-frequency sound waves to create real-time visual images of internal body structures, such as organs, tissues, and blood flow. Its primary purpose is diagnostic evaluation, making it ideal for environments where internal imaging is routinely performed, such as musculoskeletal assessments, obstetrics, or abdominal scans.

• Is this device single-use or reusable, and what does that mean for maintenance and cleaning?

  This device is reusable, as explicitly stated in the regulatory records. Since it is classified as a Class II reusable medical system, it requires proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality. Hospitals or clinics using this device must follow established protocols for reprocessing to prevent contamination and maintain performance, as it is intended for repeated use in radiology settings.

• How was the regulatory approval process for this device structured, and what does the ‘SESE’ decision mean?

  The IMAGE SCANNING TYPE SONOLAY SAL-10A received FDA 510(k) clearance under the traditional review pathway, meaning the manufacturer demonstrated that it was substantially equivalent (SESE) to a legally marketed device already on the market. The ‘SESE’ decision (Substantially Equivalent in Safety and Effectiveness) was issued in 1977, confirming that this ultrasound imaging system met the same performance criteria as its predicate device. This approval pathway is common for devices that build upon existing technology rather than introducing entirely new innovations.

• What kind of imaging capabilities does this device provide, and what internal structures can it visualize?

  As a pulsed-echo ultrasonic imaging system, the SAL-10A generates high-frequency sound waves to create visual images of internal body structures. While the exact capabilities aren’t detailed beyond its classification as a diagnostic ultrasound imaging device, such systems are typically used to visualize soft tissues, organs, blood vessels, and other anatomical features. Common applications include obstetric imaging, musculoskeletal assessments, abdominal scans, and vascular studies, though the specific use cases would depend on clinical practice and additional software/firmware configurations.