(78 days)
Signa CV/i Magnetic Resonance System
Not Found
No
The document describes a standard MRI system using Fourier transformation techniques for image reconstruction. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic imaging device" that produces images to "provide information that can be useful in determining a diagnosis," rather than treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa VH/i system is indicated for use as a diagnostic imaging device." It further explains that "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis."
No
The device description clearly states it is a "Magnetic Resonance System" which utilizes a "superconducting magnet" and acquires images using hardware components. It is a physical imaging device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Signa VH/i system is a Magnetic Resonance (MR) imaging device. It produces images of the internal structures of the head by utilizing magnetic resonance properties of protons. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head." This describes an imaging modality, not a test performed on a sample.
Therefore, the Signa VH/i system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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.
Product codes
LNH
Device Description
The 3.0T Signa VH/i Magnetic Resonance System is a modification to the Signa CV/i Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The GE 3T Signa VH/i MR System is a high resolution, head imaging system operating at 3 Tesla. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and shorter scan times.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head
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 3.0T Signa VH/i Magnetic Resonance 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 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Signa CV/i Magnetic Resonance System
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
K 990550
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
MAY 1 1 1999
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, February 19, 1999
- o Identification of the Product 3.0T Signa VH/i Magnetic Resonance System
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
o Marketed Devices
The 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the currently marketed Signa CV// Magnetic Resonance System with the only difference being a different magnetic field strength. The Signa CV/i Magnetic Resonance System has a magnetic field strength of 1.5Tesla and is a whole body scanner while the 3.0T Signa VH// Magnetic Resonance System has a magnetic field strength of 3.0T and is a head only scanner.
o Device Description
The 3.0T Signa VH/i Magnetic Resonance System is a modification to the Signa CV// Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The GE 3T Signa VH/i MR System is a high resolution, head imaging system operating at 3 Tesla. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and shorter scan times.
- o Indications for Use
The Signa VH/i System is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH// 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.
Image /page/0/Picture/16 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are four small, teardrop-shaped elements evenly spaced around the outside of the circle.
page 1 of 2
1
GE Medical Systems
page 2 of 2
P.O. Box 414, W-709 Milwaukee. WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
o Comparison with Predicate
The 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System with the main differences being the higher magnetic field strength and no body coil since the 3.0T Signa VH// System is a head only scanner.
o Summary of Studies
The 3.0T Signa VH/i Magnetic Resonance 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 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System.
o Conclusions
It is the opinion of GE that the 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the Signa CV/i Magnetic Resonance System. The 3.0T Signa VH/i Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.
Image /page/1/Picture/10 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circle. The circle has small, leaf-like shapes around its perimeter, adding a decorative element to the design. The logo is black and white.
2
Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1999
Larry A. Kroger. Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414. W-709 Milwaukee, Wisconsin 53201
Re:
K990550 3.0T Signa VH/I magnetic Resonance System Dated: February 19, 1999 Received: February 22, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. 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 legally marketed predicate 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 III (Special Controls) or class III (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 (QS) for Medical Devices: General requlation (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 concerning 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 vitro 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: 3.0T Signa VH/i MR System
Indications For Use:
The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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)
Thind A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use