(80 days)
Not Found
No
The summary describes a physical coil for MRI and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is described as providing imaging capability for an MR system, facilitating magnetic resonance imaging, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device, a coil for an MRI system, facilitates imaging. There is no information to suggest it processes the images or aids in providing a diagnosis. Its function is limited to image acquisition.
No
The device description explicitly states it is a group of "symmetric transmit/receive surface coils" contained in a "flexible, biocompatible outer covering," indicating it is a hardware component used in magnetic resonance imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic... magnetic resonance imaging." This describes a device used during an imaging procedure on a patient, not a device used to test samples outside the body (in vitro).
- Device Description: The description details "symmetric transmit/receive surface coils" used in an MR system. This aligns with the components of an imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Signa SP Flexible Coil family is a component of a medical imaging system, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging
Anatomical Site
irregular anatomy, joints, spine
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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).