(63 days)
Not Found
No
The description focuses on hardware modifications and states performance specifications are identical to the predicate device, with no mention of AI/ML.
No
The device is described as an upgrade to a Magnetic Resonance (MR) system, which is an imaging modality used for diagnosis, not therapy.
No
The device description states it is an upgrade to an existing MRI system, which is an imaging device and not a diagnostic device in itself.
No
The device description explicitly mentions hardware components (magnet, gradient coils, Body Coil) and describes it as a modification of an existing system, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a modification to an existing Magnetic Resonance (MR) system, which is an in vivo imaging modality. There is no mention of analyzing samples outside the body (in vitro).
- Focus on hardware components: The description details changes to the magnet, gradient coils, and body coil, all of which are components of an MR scanner used for imaging the human body.
- Intended Use/Indications for Use is "Not Found": While this field is missing, the context of the device description strongly suggests an imaging system, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device description clearly points to an imaging system used directly on a patient.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Gyrex V-EP is a modification of the Gyrex Privilege system that enables current owners of the Gyrex V-Dlx to upgrade to the Gyrex Privilege without having to replace their existing magnet. The differences between the Gyrex V-EP and the Standard Gyrex Privilege are the size of the magnet, the size of the gradient coils, and the size of the Body Coil. All performance specifications are identical in the two systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Not Found
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)
The performance specifications of the Gyrex V-EP are identical to those of the predicate device.
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
- Device Name: Gyrex V-EP:
K962618
SEP - 4 1996
සු ප
1.2 Classification Name: Magnetic Resonance Diagnostic Device
1.3 Submitter: Elscint, Inc., 505 Main St., Hackensack, NJ 07601
1.4 510(k) Number:_
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Identification of Predicate Device: The predicate device is the Elscint Gyrex Privilege system (K954039).
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Comparison to Predicate Device
The Gyrex V-EP is a modification of the Gyrex Privilege system that enables current owners of the Gyrex V-Dlx to upgrade to the Gyrex Privilege without having to replace their existing magnet. The differences between the Gyrex V-EP and the Standard Gyrex Privilege are the size of the magnet, the size of the gradient coils, and the size of the Body Coil. All performance specifications are identical in the two systems.
- Safety Analysis
The Bo is the same as in the predicate device, and the SAR, dB/dt, and acoustic noise have changed, but remain below the levels of concern defined by the IEC 601-2-33 final draft. The gradient coils and Body Coil comply with appropriate safety standards.
All patient contacting materials in the Gyrex V-EP are identical to those in the predicate device, and no new safety hazards related to Site Planning, Installation, and Service, or requirements for safety related labeling were introduced.
- Effectiveness Comparison
The performance specifications of the Gyrex V-EP are identical to those of the predicate device.
- Substantial Equivalency Statement
· It is Elscint's opinion that the Gyrex V-EP is substantially equivalent in safety and effectiveness to its predicate device.