Pocket Ultrasound System
by GuangDong Youkey Medical Co., Ltd.
510(k) K211746
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211746 | Date18 Feb 2022 | 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- Withdrawn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 Pocket Ultrasound System D8 is a handheld, portable ultrasound device designed for point-of-care imaging. It provides real-time visualization of internal anatomical structures, enabling rapid diagnostic assessment across clinical environments. This system is classified as a portable ultrasound machine, offering compact and wireless functionality for enhanced accessibility in various healthcare settings.
The device is supplied as a reusable, non-sterile medical instrument intended for use in clinical settings. It is cleared by the FDA under 510(k) number K211746, with a decision classification of Substantially Equivalent to a predicate device. The system is manufactured by Guangdong Youkey Medical Co., Ltd., and its compact design supports mobility for on-site diagnostic evaluations.
Other devices from GuangDong Youkey Medical Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Is this ultrasound device meant for single-use or can it be reused in a clinical setting?
The Pocket Ultrasound System D8 is designed as a reusable medical instrument, not for single-use. Since it is classified as a non-sterile device, it must be properly cleaned, disinfected, and maintained between uses in accordance with clinical protocols to ensure safety and functionality.
How portable is this device, and what kind of clinical environments is it best suited for?
The Pocket Ultrasound System D8 is explicitly described as handheld and portable, with a compact, wireless design. This makes it ideal for point-of-care imaging in diverse settings like emergency rooms, outpatient clinics, or mobile healthcare units where mobility and quick diagnostic assessments are critical.
What does the FDA clearance classification (Substantially Equivalent) mean for this device’s intended use?
The Substantially Equivalent (SESE) classification under FDA 510(k) clearance (K211746) indicates that the Pocket Ultrasound System D8 is deemed comparable to a previously approved predicate device in terms of technology and safety. This does not define its clinical indications but confirms regulatory equivalence for marketing in the U.S. under the Radiology advisory committee’s review.
How should I store this device when not in use, and are there any special considerations?
As a reusable, non-sterile device, the Pocket Ultrasound System D8 should be stored in a clean, dry environment to prevent damage or contamination. Since it’s portable and wireless, ensure it’s protected from physical impacts (e.g., drops) and extreme temperatures. Follow manufacturer guidelines for battery care if applicable, as storage conditions may affect device performance.