Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142472 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems are diagnostic ultrasound systems designed for medical imaging. These systems are used to generate ultrasound images for clinical evaluation.
The devices are supplied as non-sterile, reusable ultrasound systems intended for use in clinical settings such as radiology and women's health examinations. They are not MRI safe unless otherwise specified, and storage and handling should follow manufacturer guidelines. Authorization for marketing in the United States was granted via FDA 510(k) clearance under K142472.
Frequently asked questions
What is the Voluson E6/E8/E10 diagnostic ultrasound system used for?
The Voluson E6, E8, and E10 diagnostic ultrasound systems are designed to generate ultrasound images for clinical evaluation, particularly in radiology and women's health examinations, as stated in the device description.
Are the Voluson E6/E8/E10 systems sterile or single-use?
The Voluson E6, E8, and E10 systems are supplied as non-sterile, reusable ultrasound systems intended for repeated use in clinical settings, not as single-use or sterile devices.
How were the Voluson E6/E8/E10 systems authorized for marketing in the United States?
The Voluson E6, E8, and E10 diagnostic ultrasound systems received marketing authorization in the United States through FDA 510(k) clearance under submission number K142472, as indicated in the authorizations and specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Comparison Chart | GE Voluson E6, E8, and E10 - Probo Medical, GE Voluson E10, E8, E6 Ultrasound Comparison - Scribd, Comparison of the GE Voluson E10, E8, and E6 (Which One to Get)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142472 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K142472 24 fields · synced Sep 28, 2026