Pocket Ultrasound System C10
by Beijing Konted Medical Technology Co., Ltd EUDAMED510(k)
Active
510(k) K231354
Overview
The Pocket Ultrasound System C10 is a handheld, wireless ultrasound device classified under the nomenclature for portable diagnostic ultrasound systems. It provides real-time imaging for diagnostic purposes, enabling clinicians to visualize internal body structures such as organs, tissues, and blood flow without the constraints of traditional wired systems.
This system is designed for use in clinical, emergency, and point-of-care settings, offering portability and connectivity via WiFi to mobile devices or computers. Supplied as a reusable device, it requires proper sterilization or disinfection protocols between uses. Authorized under FDA 510(k) and MDR compliance, the C10 adheres to regulatory standards for diagnostic ultrasound equipment, ensuring safety and performance in medical environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231354 | Date20 Dec 2023 | StatusActive |
| European Union | CE/MDR 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- Withdrawn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
- FDA applicant
- Beijing Konted Medical Technology Co.,Ltd
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
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Questions
Is the Pocket Ultrasound System (C10) designed for single-use or can it be reused in a clinical setting?
The Pocket Ultrasound System (C10) is supplied as a reusable device, meaning it is intended for multiple uses in clinical settings. However, proper sterilization or disinfection protocols must be followed between uses to ensure patient safety and device performance, as outlined in the manufacturer’s guidelines for reusable medical devices.
How does the Pocket Ultrasound System (C10) differ from traditional wired ultrasound systems in terms of usability?
Unlike traditional wired ultrasound systems, the Pocket Ultrasound System (C10) is handheld and wireless, eliminating the need for cables. This design enhances portability and allows clinicians to perform real-time imaging in clinical, emergency, or point-of-care settings without being tethered to a fixed station. It also supports connectivity via WiFi to mobile devices or computers for added flexibility.
What types of internal structures can the Pocket Ultrasound System (C10) visualize, and where is it typically used?
The Pocket Ultrasound System (C10) is designed to visualize internal body structures, including organs, tissues, and blood flow, enabling diagnostic imaging. It is particularly suited for clinical, emergency, and point-of-care environments, where portability and quick access to imaging results are critical—such as in emergency rooms, outpatient clinics, or remote medical settings.
How is the regulatory approval process for the Pocket Ultrasound System (C10) structured, and what does it entail?
The Pocket Ultrasound System (C10) has been authorized through FDA 510(k) clearance and MDR compliance, meaning its safety and performance were evaluated against existing regulatory standards for portable diagnostic ultrasound systems. The FDA process involved a Traditional 510(k) review by the Radiology (RA) Advisory Committee, determining it is substantially equivalent to legally marketed predecessors, ensuring it meets necessary requirements for medical use.