(107 days)
No
The device is a sterile cover for an MRI coil, designed to protect it from fluids. There is no mention of any computational or analytical functions, let alone AI/ML.
No
The device is described as a protective cover for MRI coils, preventing fluid contamination during procedures. Its function is to protect the equipment, not to diagnose, treat, or prevent disease in a patient.
No
The device is described as a sterile cover to protect MRI coils from fluid contamination during procedures. It does not perform any diagnostic function itself.
No
The device description clearly states it is a physical cover made from PVC Film and nylon fabric, designed to protect an MRI coil from fluids. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect equipment (an MRI coil) from fluids. This is a protective function for the equipment, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a physical cover made of PVC film and nylon fabric. It does not contain reagents, calibrators, controls, or other components typically associated with in vitro diagnostic tests.
- Lack of Diagnostic Function: The device does not analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic purposes. This equipment cover does not fit that definition.
N/A
Intended Use / Indications for Use
The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.
Product codes
Not Found
Device Description
An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame.
These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Key Metrics
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
JAN 30 1997
813-942-3828
510(K) SUMMARY (as required by 807.92(c))
Requlatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689 813-942-3908 Phone:
Contact Person: Edward H. Ransom
Date of Summary:
Trade Name: GE Sterile Disposable Equipment Coil Cover
October 4, 1996
Sterile Disposable Equipment Cover Classification Name:
Fax:
Predicate Device: Contour Fabricators Inc. Bandbag, Wrap, Sterile, Disposable Fluoroscope and General Equipment Cover. K782155
Device Description/ An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame.
These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.
| Materials | Contour Fabricators | Contour Fabricators K782155 |
|---|---|---|
| Cover | PVC Film | Polyethylene |
| Strap | Foam | Rubber Band |
| Packaging | Tyvek/Mylar Pouch | Tyvek/Mylar Pouch |
| Sterilization | ETO | ETO |
Intended Use:
The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.