Voluson E6, Voluson E8, Voluson E10
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162269 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 device is an ultrasound system designed for imaging applications. It is substantially equivalent to previously cleared devices and falls under the radiology advisory committee classification.
The device was cleared via the FDA 510(k) process under special clearance type. It is manufactured by GE Healthcare and identified by K-number K162269 and product code IYN. The system is intended for use in clinical imaging settings as part of radiology practice.
Frequently asked questions
What is the Voluson E6, E8, E10 ultrasound system intended for?
The Voluson E6, E8, and E10 ultrasound systems are intended for use in clinical imaging settings as part of radiology practice, designed for general imaging applications based on their substantial equivalence to previously cleared devices.
How was the Voluson E6, E8, E10 ultrasound system cleared for market?
The device was cleared via the FDA 510(k) process under a special clearance type, determined to be substantially equivalent to previously cleared devices, with K-number K162269 and product code IYN assigned by GE Healthcare.
Who manufactures the Voluson E6, E8, E10 ultrasound system and where is it located?
The Voluson E6, E8, and E10 ultrasound systems are manufactured by GE Healthcare, located at 9900 Innovation Dr., Milwaukee County Research Park, Wauwatosa, WI 53226, United States.
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 | GE HealthCare (United States), Voluson™ Expert 20 Ultraschallsystem | GE HealthCare, Voluson Solution Store | GE HealthCare (Germany), Voluson™ E8 | Women's Health Ultrasound - GE Healthcare, Voluson Women's Health Ultrasound Machines - GE Healthcare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162269 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K162269 24 fields · synced Oct 6, 2026