HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
510(k) K192319
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) | NumberK192319 | Date10 Dec 2019 | 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- Withdrawn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 W10 Diagnostic Ultrasound Systems are portable, high-resolution ultrasound devices designed for diagnostic imaging of internal body structures. They utilise advanced transducer technology and real-time imaging to provide clear visualisation of organs, tissues, and vascular systems, supporting clinical assessments in radiology and general diagnostic procedures.
These systems are intended for use in clinical settings such as hospitals, diagnostic centres, and outpatient facilities. Supplied as reusable medical devices, they require proper maintenance and sterilisation protocols where applicable. Both models comply with FDA 510(k) clearance under the Radiology Advisory Committee and EU MDR regulations, ensuring adherence to stringent safety and performance standards. The HERA W9 and W10 are classified under product code IYN.
Other devices from Samsung Medison Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
Are the HERA W9 and W10 ultrasound systems designed for single-use or reusable in clinical settings?
The HERA W9 and W10 Diagnostic Ultrasound Systems are reusable medical devices. Since they are intended for repeated use in clinical settings like hospitals and diagnostic centres, proper maintenance and sterilisation protocols must be followed to ensure safety and performance. The manufacturer, Samsung Medison, explicitly notes this in the device description.
What types of clinical environments are these ultrasound systems intended for?
These systems are designed for clinical settings such as hospitals, diagnostic centres, and outpatient facilities. The description highlights their role in radiology and general diagnostic procedures, where high-resolution imaging of internal structures is required. Their portability and advanced transducer technology make them suitable for diverse environments where mobility and precision are needed.
How do I know if these ultrasound systems meet regulatory standards for safety and performance?
The HERA W9 and W10 comply with FDA 510(k) clearance under the Radiology Advisory Committee and EU MDR regulations. This means they have undergone rigorous evaluation to demonstrate substantial equivalence to predicate devices (for FDA) and meet EU safety, performance, and clinical effectiveness requirements. The clearance type is listed as *Traditional*, indicating a thorough review process.
What is the primary difference between the HERA W9 and W10 models, and how might that affect my purchase decision?
The HERA W9 and W10 are distinct models of the same ultrasound system family, but the data provided does not specify technical differences between them. However, both share key features like portability, high-resolution imaging, and compliance with regulatory standards. Your purchase decision may depend on factors like available funding, specific clinical needs (e.g., imaging depth or resolution requirements), or compatibility with existing workflows—not on inherent differences highlighted in the provided data.