Interson USB Ultrasound Probe System
by Regulatory Management Services
510(k) K070907
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK070907 | Date17 Apr 2007 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Interson USB Ultrasound Probe System is a Class II ultrasound probe designed for use with Windows-based devices. It functions as a handheld diagnostic tool for imaging internal body structures, enabling real-time visualization of organs, tissues, and fluids through ultrasound technology. This device is categorized under radiology equipment and is intended for medical and veterinary applications.
The system is supplied as a reusable probe intended for use in clinical settings, including radiology departments and veterinary practices. It connects via USB to compatible devices, requiring no additional power source beyond the host system. The device is cleared under FDA 510(k) (K070907) and complies with the Medical Device Directive (MDD). No specific sterility or single-use designation is stated in the regulatory data.
Other devices from Regulatory Management Services
Questions
AI-generated answers, 18 Sep 2026
Is the Interson USB Ultrasound Probe System designed for single-use or can it be reused in clinical settings?
The Interson USB Ultrasound Probe System is explicitly described as a reusable probe intended for use in clinical settings, including radiology departments and veterinary practices. Since no sterility or single-use designation is mentioned in the regulatory data, it implies the device is meant for repeated use with appropriate cleaning and maintenance between patients or procedures.
What types of devices can the Interson USB Ultrasound Probe System connect to, and does it require any additional power source?
The Interson USB Ultrasound Probe System is designed to connect via USB to Windows-based devices. Unlike traditional ultrasound systems, it does not require an external power source—it draws power directly from the host system through the USB connection, making it a plug-and-play solution for compatible computers.
Can this device be used for both human and veterinary medical imaging, and if so, what applications are it cleared for?
Yes, the Interson USB Ultrasound Probe System is cleared for both medical and veterinary applications. While the regulatory data categorizes it under radiology equipment, it is not intended for any specific clinical use beyond enabling real-time ultrasound imaging of internal body structures, organs, tissues, and fluids. The clearance (FDA 510(k) K070907) and compliance with the Medical Device Directive (MDD) support its use in these broad settings.
How is the device powered, and what kind of setup is required for use in a clinical environment?
The Interson USB Ultrasound Probe System operates by connecting directly to a Windows-based device via USB, eliminating the need for a separate power adapter. This means the only required setup is ensuring the host computer meets compatibility requirements and that the probe is properly connected. No additional hardware or power source is specified, making it a straightforward addition to existing diagnostic workflows.