(207 days)
No
The summary describes a passive hardware component (an MR coil) and makes no mention of software, algorithms, or AI/ML terms.
No
The device is described as an "Extremity Coil" for an "MR imaging system" used to "improve imaging of the knee and surrounding structures" and other extremity body parts. Its intended use is to aid in imaging, which is a diagnostic function, not a therapeutic one. The description focuses on its role in capturing images for diagnosis, not in treating a condition.
No
The device is described as an "extremity coil" for an MR imaging system, used to "accommodate and improve imaging." This indicates it is a component of an imaging system designed to acquire images, not to interpret or diagnose from those images. Diagnostic devices typically analyze data to provide a diagnosis or aid in diagnosis.
No
The device description explicitly states it is a "quadrature receive-only coil contained in a biocompatible outer shell" and includes physical components like an "adjustable positioning base and patient comfort pads," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is an extremity coil for an MR imaging system. Its purpose is to improve the quality of MR images of extremities. It is a component used during the imaging process, not a test performed on a biological sample outside the body.
- Intended Use: The intended use clearly states it "expands the capability of the 0.2T MR imaging system" and "accommodates and improves imaging." This is about image acquisition, not diagnostic testing of biological samples.
Therefore, based on the provided information, this device is a medical imaging accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 0.2T Extremity Coil expands the capability of the 0.2T MR imaging system. lt accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.
Product codes
Not Found
Device Description
The 0.2T Extremity coil is a quadrature receive-only coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed specifically for use with a vertical magnetic field MR imaging system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging system
Anatomical Site
knee and surrounding structures, ankle, wrist, other extremity body parts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The intertwined letters are enclosed within a circular shape, which is surrounded by a decorative, swirling pattern.
K954353
GE Medical Systems
"I'm sorry,"
"I can't."
1 2 1996
0.2T Extremity Coil
September 14, 1995
General Electric Medical Systems
SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
- Contact: Larry A. Kroger Phone: 414-544-3894 414-544-3863 Fax:
- Product: 0.2T Extremity Coil Manufactured by GE Yokogawa Medical System. Ltd. Tokyo, Japan
1) Indications for Use
The 0.2T Extremity Coil expands the capability of the 0.2T MR imaging system. lt accommodates and improves imaging of the knee and surrounding structures. It can also be used to image other extremity body parts such as the ankle and wrist.
2) Device Description
The 0.2T Extremity coil is a quadrature receive-only coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and patient comfort pads for support. It is designed specifically for use with a vertical magnetic field MR imaging system.
-
- Marketing History
The 0.2T Extremity Coil has not been previously marketed by GE Medical Systems.
- Marketing History
4) Potential Adverse Effects on Health
The use of the 0.2T Extremity Coil does not result in any additional potential hazards compared to previously marketed receive-only surface coils.
- ર) Conclusions
It is the opinion of GE Medical Systems that the () 2T Extremity Coil is substantially equivalent to the presently marketed GE MR Max Plus Extremity Coil (#K895794).
Image /page/0/Picture/22 description: The image shows a logo with a stylized wave and a small boat on top. Below the wave and boat, there is some text, but it is too blurry to read. The logo appears to be for a company or organization related to water or maritime activities. The overall design is simple and modern.