(73 days)
No
The summary describes a standard MRI system with updated hardware components (coils and RF channels) and does not mention any software features related to AI or ML for image processing, analysis, or interpretation.
No.
The Elscint Esteem 1.5T MRI system is an imaging device used for diagnosis, surgery planning, or therapy planning, not for providing medical therapy.
Yes
The device produces images that, when interpreted by a trained physician, provide information useful in determining a diagnosis.
No
The device description explicitly lists several hardware components, including coils and system electronics modifications, indicating it is a hardware-based medical device.
Based on the provided text, the Elscint Esteem 1.5T MRI system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Elscint Esteem 1.5T MRI system produces images of the internal structures of the body using magnetic resonance. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to produce images that, when interpreted by a trained physician, can be useful in diagnosis, surgery planning, or therapy planning. This is a direct imaging modality, not an analysis of biological samples.
Therefore, the Elscint Esteem 1.5T MRI system 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 Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
Product codes
Not Found
Device Description
The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
The major components changed or updated over that described in he predicate device submission are:
- A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic imaging.
- A semi-flexible 4-element receive-only phased array body coil for improved imaging of the liver, kidneys and hips.
- Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and temperomandibular joint:
- A circular polarized spine coil to increase image performance . in the thoracic and lumbar spine when compared to the lumbar spine coil.
- A single loop shoulder coil pair for improved patient comfort . and general utility. Large and small coils for patients of different sizes are provided.
- A circular polarized pelvic coil to improve performance in . imaging pelvic anatomy compared to the body coil alone.
- A bilateral TMJ coil for specialized imaging of . the temperomandibular joint.
In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head, body, extremities, pelvic, liver, kidneys, hips, spine, shoulder, temperomandibular joint (TMJ)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
SEP 2 0 1996
Summary of Safety and Effectiveness
The following information is made available pursuant to the requirements of the Safe Medical devices Act of 1990.
| 1. | Submitter: | Elscint MR, Inc.
2555 Midpoint Drive
Fort Collins, CO 80521
Tel: (970) 498-8088
Fax: (970) 498-8098 | |
|----|-------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| | Contact: | Elizabeth F. Lowder, Director of Quality and Programs | |
| | Date: | July 3, 1996 | |
| 2. | Trade/Proprietary Name: | | Esteem 1.5T MRI System |
| | Common Name: | | Magnetic Resonance Imaging System |
| | Classification Name: | | Magnetic Resonance Diagnostic Device |
| 3. | Predicate device: | | Esteem 1.5T MRI System (described in
K942953) |
- Device Description: বঁ
The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density. NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.
The major components changed or updated over that described in he predicate device submission are:
-
A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic imaging.
-
A semi-flexible 4-element receive-only phased array body coil for improved imaging of the liver, kidneys and hips.
-
Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and temperomandibular joint:
1
- A circular polarized spine coil to increase image performance . in the thoracic and lumbar spine when compared to the lumbar spine coil.
- A single loop shoulder coil pair for improved patient comfort . and general utility. Large and small coils for patients of different sizes are provided.
- A circular polarized pelvic coil to improve performance in . imaging pelvic anatomy compared to the body coil alone.
- A bilateral TMJ coil for specialized imaging of . the temperomandibular joint.
In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.
ട. Safety and Performance Parameters
K942953 Safety parameters unchanged from the predicate device described in are as follows:
| Static magnetic field strength: | 1.5T |
|---|---|
| Rate of change or magnetic field (dB/dt): |