(76 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and traditional MR imaging techniques.
No
The device is described as a "diagnostic imaging device" used to "produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body" for a "trained physician" to use to "determine a diagnosis." Its purpose is to provide information for diagnosis, not to treat.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use as a diagnostic imaging device" and that the images it produces "can be useful in determining a diagnosis."
No
The device description clearly indicates it is a "whole body scanner" utilizing a "superconducting magnet" and "expanded gradient capabilities," which are hardware components of an MRI system.
Based on the provided information, the Signa CVMR system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves analyzing blood, urine, tissue samples, etc., outside of the body.
- The Signa CVMR system is a whole body scanner. It produces images of the internal structures of the head or body in vivo (within the living body) using magnetic resonance.
- The intended use is diagnostic imaging. The system produces images that are interpreted by a trained physician to aid in diagnosis. This is a characteristic of medical imaging devices, not IVD devices.
The description clearly indicates that the device is a medical imaging system used for non-invasive examination of the body.
N/A
Intended Use / Indications for Use
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR 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), spinspin 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
90 LNH
Device Description
The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head or body
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)
The Signa CVMR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa CVMR System is comparable to the Signa Horizon MR Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K98 0 11
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has decorative elements around the edge, and a line extends from the bottom of the circle.
page 1 of 2
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
MAR 3 0 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- 0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, January 8, 1998
- o Identification of the Product Signa CVMR Magnetic Resonance System
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
o Marketed Devices
The Signa CVMR System is substantially equivalent to the currently marketed Signa Horizon System with the only difference being a different Body/Gradient coil.
o Device Description
The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. 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.
o Indications for Use
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR 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), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
1
GE Medical Systems
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. There are three decorative flourishes extending from the circle's edge, adding a touch of elegance to the design. The logo is presented in black and white.
page 2 of 2
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
o Comparison with Predicate
The Signa CVMR System is comparable to the Signa Horizon Systems with the main difference being with the Body/Gradient coil which allows for expanded gradient capabilities, enabling shorter scan times.
o Summary of Studies
The Signa CVMR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa CVMR System is comparable to the Signa Horizon MR Systems.
Conclusions
0
It is the opinion of GE that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The Signa CVMR Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the people served by the department. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1998
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K980114 Signa CVMR Magnetic Resonance System Dated: January 12, 1998 Received: January 13, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements coucerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vito diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.html".
Sincerely yours,
Kiliai Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_ K98 0114
Device Name: Signa CVMR System
Indications For Use:
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seysom
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use