Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121063 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 Vivid S5 Diagnostic Ultrasound System and Vivid S6 Diagnostic Ultrasound System are diagnostic ultrasound systems intended for use in radiology applications. These systems are designed to generate and display ultrasound images for diagnostic purposes.
The devices are supplied as non-sterile, reusable systems for use in clinical environments. They are authorized under FDA 510(k) clearance (K121063) and are not indicated for MRI use. No specific sizes, storage conditions, or single-use designations are provided in the data.
Frequently asked questions
What is the Vivid S5 S6 Diagnostic Ultrasound System intended for?
The Vivid S5 and S6 diagnostic ultrasound systems are intended for use in radiology applications to generate and display ultrasound images for diagnostic purposes, as stated in the device description.
How is the Vivid S5 S6 Diagnostic Ultrasound System supplied and is it sterile or single-use?
The system is supplied as a non-sterile, reusable system for use in clinical environments, meaning it is designed for multiple uses after appropriate cleaning and is not provided in a sterile condition.
What regulatory authorization does the Vivid S5 S6 Diagnostic Ultrasound System have?
The Vivid S5 and S6 diagnostic ultrasound systems are authorized under FDA 510(k) clearance with K-number K121063, indicating they were found substantially equivalent to a legally marketed predicate device.
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: GE VIVID S5 USER MANUAL Pdf Download, Vivid Cardiovascular Ultrasound Systems - GE Healthcare, Vivid s5 s6 User Manual | PDF | Medical Ultrasound - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121063 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical System Israel , Ltd.
Sources (1)
- FDA 510(k) K121063 24 fields · synced Oct 6, 2026