(70 days)
Signa Contour System
Not Found
No
The summary describes a standard MRI system and its imaging capabilities, with no mention of AI or ML features for image analysis, processing, or interpretation.
No
The device is indicated for diagnostic imaging to provide information useful in determining a diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device" and that the images "provide information that can be useful in determining a diagnosis."
No
The device description clearly outlines hardware components like a superconducting magnet and discusses imaging options and system configurations (stationary or mobile), indicating it is a hardware-based imaging system, not software-only.
Based on the provided information, the Signa Contour 2 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body." This describes an in-vivo imaging system, not a device used to examine specimens taken from the body (which is the definition of in-vitro).
- Device Description: The description details a Magnetic Resonance (MR) system, which is used to image the inside of a living body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in-vitro diagnostics.
Therefore, the Signa Contour 2 System is an in-vivo diagnostic imaging device.
N/A
Intended Use / Indications for Use
The Signa Contour 2 System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes
Not Found
Device Description
The Signa Contour 2 System utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. A wide variety of pulse sequences is provided to the operator, including inversion recovery, spin echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fathwater suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
The Signa Contour 2 System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Contour 2 System is comparable to the Signa Contour MR System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Signa Contour System
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
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
JAN | 0 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, November 1, 1996
- o Identification of the Product Signa Contour 2 Magnetic Resonance System
Manufactured by:
GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-shi Tokyo, 191 Japan
- Marketed Devices The Signa Contour 2 MR System with new 0.5T magnet is substantially equivalent to the currently marketed Signa Contour System (software and electronics).
o Device Description
o
o
The Signa Contour 2 System utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. A wide variety of pulse sequences is provided to the operator, including inversion recovery, spin echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fathwater suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile system.
Indications for Use
The Signa Contour 2 System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Image /page/0/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, contrasting with the white background.
page 1 of 2
1
GE Medical Systems
page 2 of 2
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
o Comparison with Predicate
The magnets used with the Signa Contour 2 System are 45 Kg lighter and has a zero cryogen boil off rate as compared to 0.075 liters per hour for the Signa Contour System.
o Summary of Studies
The Signa Contour 2 System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Contour 2 System is comparable to the Signa Contour MR System.
o Conclusions
It is the opinion of GE that the Signa Contour 2 System is substantially equivalent to the Signa Contour MR Systems. The Signa Contour 2 does not include any new indications for use, nor does use of this device result in any new potential hazards.