Voluson E6, E8, E10 Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152567 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)
The Voluson E6, E8, and E10 are diagnostic ultrasound systems designed for obstetrics and gynecology imaging. These devices provide high-resolution imaging capabilities, enabling detailed visualization of soft tissues, fetal development, and reproductive organs. They are classified as substantially equivalent diagnostic ultrasound systems under FDA regulations, adhering to radiology standards for medical imaging.
These systems are intended for use in clinical settings such as hospitals, diagnostic centers, and private practices. Supplied as reusable medical equipment, they require proper maintenance and calibration to ensure accurate performance. The Voluson E6, E8, and E10 are authorized under FDA 510(k) clearance (K152567) and are manufactured by GE Healthcare. No specific sterility or MRI safety information is provided in the available data.
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: Voluson™ Ultraschallsysteme für die Frauenheilkunde, Comparison of the GE Voluson E6, E8 and E10 - LBN Medical, Voluson™ S8 Touch - GE HealthCare Ultraschall, Comparison Chart | GE Voluson E6, E8, and E10 - Probo Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152567 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K152567 24 fields · synced Oct 6, 2026