SONON Ultrasound Imaging System Model 300L
by Healcerion Co., Ltd. South Korea EUDAMED510(k)
510(k) K170085 Product code IYN
Overview
The SONON Ultrasound Imaging System Model 300L is a diagnostic ultrasound device designed for real-time imaging of internal body structures using high-frequency sound waves. It provides visualisation of organs, tissues, and blood flow, aiding in the diagnosis and monitoring of various medical conditions such as cardiovascular, obstetric, and abdominal assessments.
This system is intended for use in clinical settings, including hospitals and diagnostic centres, and is supplied as a reusable medical device. It is authorised under FDA 510K clearance and MDD compliance, ensuring adherence to regulatory standards for safety and performance. The device requires proper maintenance and calibration to ensure accurate imaging results, with no specific sterility requirements stated for its reusable components.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK170085 | Date12 Oct 2017 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Healcerion Co., Ltd.
Questions
What types of medical assessments is the SONON Ultrasound Imaging System, Model 300L, primarily used for in clinical settings?
The SONON Ultrasound Imaging System, Model 300L, is designed for real-time imaging of internal structures like organs, tissues, and blood flow. Clinically, it supports assessments in areas such as cardiovascular, obstetric, and abdominal evaluations, helping diagnose and monitor medical conditions in those fields.
Is the SONON Ultrasound Imaging System, Model 300L, intended for single-use or reusable applications, and what does that mean for maintenance?
The SONON Ultrasound Imaging System, Model 300L, is supplied as a reusable medical device. This means it is built for repeated use in clinical settings, but it requires proper maintenance and calibration to ensure consistent accuracy and performance over time, as outlined in the manufacturer’s guidelines.
What regulatory pathways has the SONON Ultrasound Imaging System, Model 300L, followed, and what does that imply for its compliance?
The SONON Ultrasound Imaging System, Model 300L, has been authorized under both FDA 510(k) clearance and MDD compliance. This implies the device meets regulatory standards for safety and performance in the United States and aligns with European medical device directives, ensuring it adheres to strict quality and safety requirements.
Does the SONON Ultrasound Imaging System, Model 300L, require any special handling for sterility, given it is a reusable device?
Since the SONON Ultrasound Imaging System, Model 300L, is a reusable device, no specific sterility requirements for its components are mentioned in the provided data. However, standard clinical protocols for cleaning, disinfection, and maintenance should be followed to prevent contamination and ensure safe, repeated use.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K170085
- EUDAMED