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InnoSight Diagnostic Ultrasound System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172056

by Qisda Corporation

Identifiers

510(k) Number
K172056 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The InnoSight Diagnostic Ultrasound System is a diagnostic ultrasound device designed for imaging internal body structures using high-frequency sound waves. It provides real-time visualization of organs, tissues, and blood flow, aiding in the diagnosis and monitoring of various medical conditions such as cardiovascular, abdominal, and obstetric assessments.

This system is intended for use in clinical settings, including hospitals, diagnostic imaging centers, and outpatient facilities. Supplied as a reusable medical device, it requires proper maintenance and sterilization protocols as per manufacturer guidelines. The device adheres to FDA 510(k) clearance under the Radiology Advisory Committee and is also authorized under the EU Medical Device Regulation (MDR). Its design and functionality are governed by regulatory standards to ensure safety and performance in diagnostic imaging applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Qisda Corporation

Sources (2)

  • FDA 510(k) K172056 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026