(85 days)
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No
The document describes accessories for an existing MR system, focusing on physical features and patient positioning. There is no mention of AI, ML, or advanced image processing that would typically indicate the use of such technologies.
No
The provided text describes a system used for MR imaging, localization of scanning planes, and patient positioning for diagnostic purposes. It does not mention any therapeutic claims or functions.
Yes
Explanation: The device is an MR imaging system used to acquire images of anatomical sites, which are then displayed to an operator. This process of acquiring and displaying images for an operator to interpret is characteristic of diagnostic devices. Although it does not mention 'image processing', 'AI', 'DNN', or 'ML', the core function of imaging and displaying for evaluation places it in the diagnostic category.
No
The device description explicitly mentions "optional accessories" including a "Scan Plane Pointer accessory" and a "Patient Imaging Chair," which are physical hardware components. The performance studies also refer to evaluating the "Signa SP optional accessories" to hardware performance and safety standards (NEMA and IEC 601-1).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as facilitating localization of scanning planes, allowing multiple patient positions for imaging exams, and enabling MR imaging during interventional procedures. These are all related to in vivo imaging (imaging within a living organism).
- Device Description: The description focuses on the physical configuration of the MR system and the function of the accessories in relation to patient positioning and image acquisition. This aligns with an in vivo imaging device.
- Input Imaging Modality: The input modality is MR Imaging, which is an in vivo imaging technique.
- Anatomical Site: The anatomical sites mentioned are dynamic joints and the spine, which are parts of the human body being imaged directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis, which are hallmarks of IVD devices.
Therefore, the Signa SP System optional accessories, as described, are intended for use in in vivo medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Signa SP System optional accessories are indicated for use as follows:
- The Scan Plane Pointer facilitates localization of the scanning planes.
- . The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies.
- . The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.
Product codes
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Device Description
The Signa SP System employs an open magnet configuration which helps to reduce patient anxiety. increases patient positioning options and allows easy access to the patient. The Scan Plane Pointer accessory is useful in acquiring MR images relative to the physical orientation of the patient. The images may then be displayed to the operator and on a screen at table side.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MR Imaging
Anatomical Site
knees, shoulders, spine
Indicated Patient Age Range
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Intended User / Care Setting
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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 SP optional accessories was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Evaluation testing confirmed accuracy statements in the User Manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
0
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 circle. There are decorative swirls or flourishes around the letters and within the circle, giving the logo a classic and recognizable appearance. The logo is in black and white.
GE Medical Systems
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P.O. Box 414, W-709 Milwaukee, Wi 53201 USA
NOV - 7 1996
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, August 2, 1996
- o Identification of the Product Signa SP Magnetic Resonance System - Optional Accessories
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
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0 Marketed Devices
The Signa SP Magnetic Resonance System with optional accessories is substantially equivalent to the currently marketed Signa SP System. -
o Device Description
The Signa SP System employs an open magnet configuration which helps to reduce patient anxiety. increases patient positioning options and allows easy access to the patient. The Scan Plane Pointer accessory is useful in acquiring MR images relative to the physical orientation of the patient. The images may then be displayed to the operator and on a screen at table side. -
o Indications for Use
The Signa SP System optional accessories are indicated for use as follows: -
The Scan Plane Pointer facilitates localization of the scanning planes. .
-
. The side entry patient support access feature and the Patient Imaging Chair allows multiple patient positions enabling imaging exams of dynamic joints (such as knees and shoulders) and loaded spine studies.
-
. The use of MR Imaging during interventional procedures using common devices such as fine needles and suction.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The letters are stylized and connected in a cursive-like manner. The logo is black and white, with the letters and the inner part of the circle being black, and the background being white.
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
o Comparison with Predicate
The Signa SP Magnetic Resonance System with optional accessories, namely the Patient Support Chair, side docking of the patient support table and the Scan Plane Pointer give more imaging functionality.
o Summary of Studies
The Signa SP optional accessories was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard. Evaluation testing confirmed accuracy statements in the User Manual.
o Conclusions
It is the opinion of GE that the Signa SP optional accessories is substantially equivalent to the Signa SP Systems. The optional accessories do not result in any new potential hazards.
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