Identifiers
- 510(k) Number
- K240571 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 OASIS MRI System is a nuclear magnetic resonance imaging device designed for high-field open MRI applications. It provides detailed imaging of internal body structures without the confining space of traditional closed-bore systems, enhancing patient comfort and accessibility for a broader range of patients.
This system is intended for use in radiology settings and is supplied as a reusable medical device. It operates under FDA clearance (510K) and is classified as a Class II device. The OASIS MRI System is not single-use and requires proper MRI-safe storage and handling to maintain performance and safety standards.
Frequently asked questions
What types of patients can benefit from using the OASIS MRI System compared to traditional closed-bore MRI machines?
The OASIS MRI System is designed for high-field open MRI applications, which means it provides a more spacious and less confining environment than traditional closed-bore MRI machines. This makes it particularly beneficial for patients who experience claustrophobia, obesity, or other conditions that make fitting into a closed bore difficult. The open design also enhances accessibility for a broader range of patients, improving comfort and reducing anxiety during imaging.
Is the OASIS MRI System intended for single-use or can it be reused in clinical settings?
The OASIS MRI System is explicitly described as a reusable medical device. This means it is engineered for repeated use in radiology settings, provided it undergoes proper maintenance, cleaning, and MRI-safe storage to ensure performance and safety standards are maintained.
What regulatory pathway was followed for the OASIS MRI System’s FDA clearance?
The OASIS MRI System received FDA clearance through a 510(k) Traditional pathway, classified as a Class II device under the Radiology advisory committee (RA). The decision was based on a determination of substantial equivalence (SESE) to a predicate device, as indicated by the clearance type and decision code.
How should the OASIS MRI System be stored to ensure safety and functionality?
The OASIS MRI System requires MRI-safe storage and handling to maintain performance and safety. Since it is a reusable device, proper maintenance protocols—including cleaning, calibration, and adherence to manufacturer guidelines—are essential. Storage must comply with MRI safety standards to prevent interference or damage to the system.
What is the primary medical specialty or clinical setting where the OASIS MRI System is intended for use?
The OASIS MRI System is intended for use in radiology settings, as explicitly stated in its description and regulatory filings. It is not tied to a specific clinical indication but rather serves as a versatile imaging tool for detailed visualization of internal body structures in an open-bore configuration.
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: MRI Solutions for All Sizes & Budgets | Fujifilm Healthcare, High-Field Open MRI Machines | Fujifilm Healthcare Solutions, Velocity Oasis | Fujifilm Healthcare
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240571 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Healthcare Corporation
Sources (1)
- FDA 510(k) K240571 24 fields · synced Oct 6, 2026