Identifiers
- 510(k) Number
- K221619 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ECHELON Oval V6.2 MRI System is a nuclear magnetic resonance imaging system designed for radiology applications. It is a 1.5T magnetic resonance imaging system with an oval wide-bore configuration intended to accommodate a broad patient spectrum while maintaining image quality.
The system is supplied as a reusable medical device for use in clinical imaging settings. It has received FDA 510(k) clearance under K221619 and is classified as a Class II device under regulation number 892.1000 with product code LNH. The device is manufactured by Fujifilm Healthcare Corporation and is intended for use in radiology departments for diagnostic imaging procedures.
Frequently asked questions
What is the ECHELON Oval V6.2 MRI System used for?
The ECHELON Oval V6.2 MRI System is designed for radiology applications and intended for diagnostic imaging procedures in clinical imaging settings, providing 1.5T magnetic resonance imaging with an oval wide-bore configuration to accommodate a broad patient spectrum while maintaining image quality.
Is the ECHELON Oval V6.2 MRI System reusable or single-use?
The ECHELON Oval V6.2 MRI System is supplied as a reusable medical device, meaning it is intended for multiple uses in clinical imaging settings after appropriate cleaning and maintenance between procedures, as indicated in the device description.
What regulatory clearance does the ECHELON Oval V6.2 MRI System have?
The ECHELON Oval V6.2 MRI System has received FDA 510(k) clearance under submission number K221619, which is explicitly stated in the device data as its authorization pathway.
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: Closed MRI Machines with Wide Openings | Fujifilm Healthcare, K221619 FDA 510(k) - ECHELON Oval V6.2 MRI System, PDF SPECIFICATION DATA - FUJIFILM Healthcare Americas Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221619 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Healthcare Corporation
Sources (1)
- FDA 510(k) K221619 24 fields · synced Oct 6, 2026