EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
510(k) K234153
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK234153 | Date18 Sep 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 19 Sep 2026
The EdgeLife Handheld Wireless Ultrasound System (E8200; E8220) is a handheld, wireless, portable diagnostic imaging device classified as a pulsed Doppler and ultrasound imaging system under the IYN product code. It employs pulsed-echo technology to generate real-time ultrasound images in B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) modes, enabling comprehensive soft-tissue and vascular assessments.
This system is designed for use in clinical, emergency, and point-of-care settings, where its wireless and portable form factor facilitates rapid deployment. Supplied as a reusable device, it requires proper sterilization and maintenance per manufacturer guidelines. The EdgeLife Handheld Wireless Ultrasound System holds FDA 510(k) clearance (K234153) and is intended for use in environments where MRI safety considerations may apply, though specific compatibility details should be verified with the manufacturer.
Other devices from Edgelife Technologies, LLC
Questions
AI-generated answers, 19 Sep 2026
What clinical imaging modes does the EdgeLife Handheld Wireless Ultrasound System support, and how might this benefit point-of-care settings?
The EdgeLife Handheld Wireless Ultrasound System supports B-Mode, M-Mode, Color Doppler, and Pulse-Wave Doppler (PW) imaging modes. These modes enable comprehensive assessments of both soft tissues and blood flow, making it versatile for rapid diagnostics in emergency, clinical, or point-of-care environments where quick, wireless imaging is critical. The wireless capability also allows for flexible deployment without tethering to fixed equipment.
Is the EdgeLife Handheld Wireless Ultrasound System designed for single-use, or does it require sterilization between patients?
The device is not single-use—it is classified as a reusable system. Proper sterilization and maintenance are required between uses, following the manufacturer’s guidelines to ensure safety and functionality. This design supports long-term clinical use in settings where portability and durability are priorities.
What types of settings is this device intended for, and why is its wireless feature significant?
The EdgeLife Handheld Wireless Ultrasound System is designed for clinical, emergency, and point-of-care settings, where its wireless and portable form factor enables rapid deployment without the need for stationary equipment. The wireless feature is particularly significant in dynamic environments (e.g., ERs, ambulances, or remote clinics) where mobility and ease of use are essential for timely diagnostics.
Are there any MRI safety considerations for this device, and how should users verify compatibility?
The device is intended for use in environments where MRI safety considerations may apply, though specific compatibility details are not detailed in the provided data. Users should consult the manufacturer’s documentation or contact Edgelife Technologies directly to confirm whether the system meets safety standards for use near MRI equipment, as improper placement could pose risks.