Identifiers
- 510(k) Number
- K113758 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Voluson E6/E8/E8Expert/E10 is a medical device categorized under radiology. It is designed to function as a diagnostic ultrasound system for clinical imaging applications.
This device is manufactured by GE Healthcare and has received FDA 510(k) clearance. It is intended for use in professional medical settings by trained healthcare personnel.
Frequently asked questions
What is the primary purpose of the Voluson E6/E8/E8Expert/E10?
This device is designed to function as a diagnostic ultrasound system. It is intended for use in professional medical settings to perform clinical imaging applications.
Who is authorized to operate this ultrasound system?
The system is intended for use exclusively by trained healthcare personnel. This ensures that the diagnostic imaging is performed by individuals with the necessary clinical expertise.
Has this device received regulatory clearance?
Yes, the Voluson E6/E8/E8Expert/E10 series has received FDA 510(k) clearance. This indicates that the device has been reviewed and cleared for use in accordance with regulatory standards.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113758 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K113758 24 fields · synced Oct 6, 2026