(183 days)
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No
The document describes a standard MRI system and its capabilities, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as a "diagnostic imaging device" used to "produce images" that "provide information that can be useful in determining a diagnosis," not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa Horizon Cx System is indicated for use as a diagnostic imaging device".
No
The device description explicitly mentions a superconducting magnet and other hardware components necessary for acquiring magnetic resonance images, indicating it is a hardware-based system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Signa Horizon Cx System Function: The description clearly states that the Signa Horizon Cx System is a diagnostic imaging device that produces images of the internal structures of the head or body. It uses magnetic resonance to acquire these images directly from the patient's body (in vivo).
The device's function is to create images of internal structures, not to analyze samples taken from the body. Therefore, it falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagital, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System 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
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Device Description
The Signa Horizon Cx System utilizes a superconducting maanet 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 echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile svstem.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures of the head or body
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Signa Horizon Cx System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Horizon Cx System is comparable to the Signa Horizon MR Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
NOV 2 7 1996
296206|
GE Medical Systems
P.O. Box 414. W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- 0 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, May 24, 1996
- o Identification of the Product Signa Horizon Cx Magnetic Resonance System
| Manufactured by: | GE Medical Systems
3200 N. Grandview Blvd.
Waukesha, WI 53188 |
| ------------------ | --------------------------------------------------------------------- |
|---|
- o Marketed Devices
The Signa Horizon Cx MR System with new 1.5T and 1.0T magnets is substantially equivalent to the currently marketed Signa Horizon System (software and electronics).
o Device Description
The Signa Horizon Cx System utilizes a superconducting maanet 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 echo, gradient recalled, and steady state, free precession acquisitions. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system can be used as a stationary or mobile svstem.
Indications for Use
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, sagital, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Horizon Cx System 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.
ge 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
0 Comparison with Predicate
The magnets used with the Signa Horizon Cx System are 2 Tons lighter and have a lower cryogen boil off rate than the Signa Horizon magnets. The new magnets are also 68 cm shorter that the Horizon magnets.
0 Summary of Studies
The Signa Horizon Cx System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. The Signa Horizon Cx System is comparable to the Signa Horizon MR Systems.
Conclusions
o
It is the opinion of GE that the Signa Horizon Cx System is substantially equivalent to the Signa Horizon MR Systems. The Signa Horizon Cx does not include any new indications for use, nor does use of this device result in any new potential hazards.