Identifiers
- 510(k) Number
- K160185 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 Wrist 3 MRI System is a Class II medical device designed for nuclear magnetic resonance imaging (MRI). It is a compact MRI scanner intended for radiology applications, enabling detailed imaging of small anatomical structures, including the wrist.
This system is supplied as a reusable device and is intended for use in MRI-compatible environments. It has received FDA 510(k) clearance under the classification code LNH, with a decision date of March 1, 2016, and is regulated under the regulation number 892.1000. The device is intended for research, scientific, and educational purposes, as well as patient care.
Frequently asked questions
What is the primary use case for the Wrist 3 MRI System in clinical settings?
The Wrist 3 MRI System is specifically designed for detailed nuclear magnetic resonance imaging (MRI) of small anatomical structures, particularly the wrist. Its compact design makes it suitable for radiology applications where high-resolution imaging of wrist anatomy is required, supporting both patient care and research purposes.
Is the Wrist 3 MRI System intended for single-use or reusable applications?
The Wrist 3 MRI System is supplied as a reusable device, meaning it is engineered for repeated use in MRI-compatible environments. This design aligns with its intended use for clinical, research, and educational settings where durability and long-term reliability are essential.
What regulatory pathway was followed for the FDA clearance of the Wrist 3 MRI System?
The Wrist 3 MRI System received FDA 510(k) clearance through a traditional review process, classified under product code LNH. The decision was made by the Radiology (RA) advisory committee, and the clearance was granted on March 1, 2016, under regulation number 892.1000. This pathway confirms its compliance with U.S. regulatory standards for Class II medical devices.
How would you describe the intended scope of use for the Wrist 3 MRI System beyond clinical patient care?
Beyond patient care, the Wrist 3 MRI System is explicitly intended for research, scientific, and educational purposes. This broader scope ensures its utility in academic settings, medical training, and specialized studies where wrist imaging is critical, such as biomechanical or anatomical research.
What type of environment is the Wrist 3 MRI System designed to operate in?
The Wrist 3 MRI System is designed for use in MRI-compatible environments, meaning it must be operated within facilities equipped to handle electromagnetic interference and safety protocols required for MRI technology. This ensures compatibility with existing MRI infrastructure while maintaining imaging accuracy and patient safety.
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: Aspect Wrist 3 - allmed.wiki, Wrist 3 | Aspect Imaging, Ltd. | Aletia Index, MRI Solutions - Compact MRI Systems for Preclinical Imaging, Wrist 3 (K160185) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160185 | Class II | Active |
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Manufacturer
- Manufacturer
- Aspect Imaging, Ltd.
Sources (1)
- FDA 510(k) K160185 24 fields · synced Sep 19, 2026