HERA W9, HERA W10 Diagnostic Ultrasound System
510(k) K211824
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) | NumberK211824 | Date9 Sep 2021 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 18 Sep 2026
The HERA W9 and HERA W10 are diagnostic ultrasound systems designed for medical imaging. They provide real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes.
These systems are intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient facilities. Supplied sterile or non-sterile as per facility requirements, they are regulated under FDA 510(k) clearance (K211824) and EU MDR compliance. The devices are available in two models, W9 and W10, and require proper storage and maintenance as specified by the manufacturer.
Other devices from Samsung Medison Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What clinical settings are the HERA W9 and W10 ultrasound systems approved for use in?
The HERA W9 and W10 are designed for use in clinical environments such as hospitals, diagnostic imaging centers, and outpatient facilities. Their primary purpose is to provide real-time visualization of internal body structures, enabling clinicians to evaluate organs, tissues, and blood flow for diagnostic assessments. The systems are not limited to a single specialty but are particularly relevant in radiology-based workflows, as indicated by their submission to the FDA’s Radiology Advisory Committee.
Are the HERA W9 and W10 systems single-use or reusable, and how should they be handled?
The HERA W9 and W10 are not single-use devices—they are designed for repeated use in clinical settings. Sterility requirements depend on facility protocols, as the systems can be supplied either sterile or non-sterile based on user preference. Proper storage and maintenance, as outlined by Samsung Medison, are critical to ensure device performance and hygiene, particularly in shared environments like hospitals or outpatient clinics.
What distinguishes the W9 model from the W10 model, and which one should I choose?
The HERA W9 and W10 are two distinct models offered by Samsung Medison, but the provided data does not specify technical differences between them beyond their model designation. The choice depends on facility needs, budget, and compatibility with existing workflows. Both models share the same regulatory pathway (FDA 510(k) clearance under K211824) and are intended for general diagnostic ultrasound applications. Consulting the manufacturer’s detailed specifications or a sales representative would clarify any functional or performance distinctions.
How do I know if this device meets regulatory requirements for my region?
The HERA W9 and W10 are cleared under the FDA’s 510(k) pathway (K211824) and comply with the EU Medical Device Regulation (MDR). For U.S. use, the FDA clearance confirms substantial equivalence to a predicate device, while MDR compliance ensures adherence to EU standards. Always verify local regulatory bodies’ requirements (e.g., Health Canada, TGA) if deploying outside the U.S. or EU, as additional approvals may be needed. The manufacturer’s documentation should outline regional compliance details.