Ge 8CH Foot Ankle Coil
by Ge Hangwei Medical Systems Co., Ltd. 510(k)
Active
510(k) K122694
Overview
The GE 8-Channel Foot Ankle Coil is a receive-only radiofrequency (RF) surface coil designed specifically for magnetic resonance imaging (MRI). It is classified as a specialty MRI coil and is intended for high-resolution imaging of the foot and ankle, enhancing signal reception for improved diagnostic clarity in radiology applications.
This coil is supplied for use with 1.5 Tesla (1.5T) MRI systems manufactured by GE Healthcare and is classified as a Class II medical device under FDA regulations. It is intended for single-patient use and requires proper handling and storage to maintain sterility and performance. The device holds an FDA 510(k) clearance (K122694) and is regulated under the Medical Specialty category for radiology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122694 | Date25 Oct 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MOS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ge Hangwei Medical Systems Co., Ltd.
Questions
What MRI systems is this coil compatible with, and why is this important for my facility?
The GE 8-Channel Foot Ankle Coil is designed exclusively for use with 1.5 Tesla (1.5T) MRI systems manufactured by GE Healthcare. This compatibility ensures optimal signal reception and imaging performance for foot and ankle scans, as the coil is engineered to work seamlessly with GE’s 1.5T hardware. If your facility uses a different MRI manufacturer or field strength, this coil may not function as intended, potentially compromising diagnostic clarity.
Is this coil intended for reuse or single-patient use, and how should it be handled to maintain performance?
The coil is intended for single-patient use only, meaning it should not be reused across multiple patients. Proper handling and storage are critical to preserve sterility and performance. Since it is a Class II medical device, adherence to manufacturer guidelines for cleaning, storage, and disposal (if applicable) is essential to prevent contamination and ensure reliable imaging results.
Are there multiple sizes or models of this coil, or is it a single unified design?
The provided data does not specify distinct sizes or models for the GE 8-Channel Foot Ankle Coil, implying it is likely a single unified design optimized for general foot and ankle imaging. However, the coil is listed under multiple FEI numbers (Foreign Entity Identification numbers), which may reflect variations in regulatory tracking rather than physical differences. Always verify compatibility with your specific MRI system before use.
How should this coil be stored to ensure it remains sterile and functional for future use?
Since the coil is single-use, storage instructions focus on maintaining its condition until first use. It should be stored in a clean, dry, and protected environment (e.g., original packaging) away from direct sunlight, moisture, or extreme temperatures. If the coil is part of a sterile kit (as implied by single-patient use), follow the manufacturer’s packaging guidelines to preserve sterility until deployment. Reuse is not permitted, so storage is only relevant for inventory management.
What regulatory pathway was followed for this device’s approval, and what does that mean for my facility?
The coil holds an FDA 510(k) clearance (K122694) under the Traditional 510(k) Review pathway, determined to be *substantially equivalent* to a legally marketed predicate device. This means the FDA reviewed it as a Class II medical device under the Radiology specialty category and confirmed it meets performance and safety standards for MRI coils. For your facility, this indicates the device has undergone regulatory scrutiny for compatibility with MRI systems and clinical safety, but you should still verify compatibility with your specific GE 1.5T system before purchase.