(207 days)
No
The summary describes a physical coil for MR imaging and does not mention any software or processing capabilities that would suggest AI/ML.
No
The device is described as an imaging coil for MR imaging, which is used for diagnostic purposes, not for treatment or therapy.
No
The device is described as an imaging coil that expands the capability of an MR imaging system for imaging anatomical structures. It facilitates image acquisition but does not itself perform diagnosis or provide diagnostic information.
No
The device description explicitly states it is a physical coil contained in a shell with an adjustable base and comfort pads, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for imaging of anatomical structures (cervical spine, neck, shoulder). IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description details a coil used in an MR imaging system, which is a medical imaging modality, not a laboratory diagnostic tool.
- Input Imaging Modality: The input is MR imaging, which is an in-vivo imaging technique, not an in-vitro diagnostic test.
The device is a component of an MR imaging system, which is used for diagnostic imaging in vivo.
N/A
Intended Use / Indications for Use
The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accomodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.
Product codes
Not Found
Device Description
The 0.2T GP Neck/Shoulder Coil is a receive-only, linear, circular solencidal coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and comfort pads for support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
cervical spine, neck, shoulder and surrounding structures
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 a circular logo with a stylized design. The logo appears to be a dark color, possibly black, against a lighter background. The design within the circle is intricate and abstract, with curved lines and shapes that create a sense of movement and complexity.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '5', '4', '3', '5', and '4'. The digits are written in a cursive style, with some of them connected to each other. The overall appearance suggests that the sequence was written quickly and informally.
GE Medical Systems
Commit Electric Company
O Box 414, Milwaukee, WT 53201
APR 1 2 1996
0.2T GP Neck/Shoulder 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:
- 0.2T GP Neck/Shoulder Coll Product: Manufactured by GE Yokogawa Medical System, Ltd. Tokyo, Japan
1) Indications for Use
The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accomodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.
2) Device Description
The 0.2T GP Neck/Shoulder Coil is a receive-only, linear, circular solencidal coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and comfort pads for support.
3) Marketing History
The 0.2T GP Neck/Shoulder Coil has not been previously marketed by GE Medical Systems.
4) Potential Adverse Effects on Health
The use of the 0.2T GP Neck/Shoulder Coil does not result in any additional potential hazards compared to previously marketed receive-only surface coils.
5) Conclusions
It is the opinion of GE Medical Systems that the 0.2T GP Neck/Shoulder Coil is substantially equivalent to the presently marketed GE Shoulder Surface Coll (#K892235).