(80 days)
The Signa SP Flexible Coll family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.
The Signa SP Flex Colls are a group of symmetric transmit/receive surface colls of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering.
I am sorry, but the provided text is a 510(k) summary for a medical device (Signa SP Flex Coils) from 1997. It describes the device, its intended use, and its substantial equivalence to a predicate device.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot extract the requested information from the given input. The information you are asking for typically comes from a detailed clinical study report, which is not present here.
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JAN 17 1997
GE Medical Systems
General Electric Company
P.O. Box 414, Milwaukee, WI 53201
Signa SP Flex Coils
October 28, 1996
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).
- Larry A. Kroger, Ph.D. Contact: Phone: 414-544-3894 414-544-3863 FAX:
- Signa SP Flex Coils Product: Manufactured by General Electric Medical Systems Waukesha, Wisconsin, USA
1) Indications for Use
The Signa SP Flexible Coll family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.
2) Device Description
The Signa SP Flex Colls are a group of symmetric transmit/receive surface colls of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering.
3) Marketing History
The Signa SP Flex Colls have not been previously marketed by GE Medical Systems.
4) Potential Adverse Effects on Health
The use of the Signa SP Flex Colls does not result in any additional potential hazards compared to previously marketed flexible transmit/receive surface colls.
5) Conclusions
It is the opinion of GE Medical Systems that the Signa SP Flex Colls are substantially equivalent to the presently marketed transmit/receive flexible surface coll contained in the Signa SP MR System (K942604).
§ 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.