(85 days)
Not Found
Signa Profile 0.2T permanent magnet
No
The document describes standard MRI technology and image reconstruction techniques (Fourier transformation). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as a "diagnostic imaging device" used to produce images for determining a diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The HFO/i system is indicated for use as a diagnostic imaging device". It further explains that the images produced "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 is an "open style magnet operating at 0.7T". This indicates it is a hardware device, not software-only.
Based on the provided text, the Signa HFO/i system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body. The Signa HFO/i system is a whole-body scanner that images the internal structures and organs within the body.
- The intended use describes producing images of internal structures and organs. This is characteristic of in-vivo imaging, not in-vitro testing.
- The device description details a magnetic resonance system. MRI is an imaging modality used to visualize internal anatomy, not to analyze biological samples.
Therefore, the Signa HFO/i system is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signa HFO/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The HFO/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the HFO/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.
Due to the 'open' design of the system, the HFO/i may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Product codes
LNH
Device Description
The Signa HFO/i Magnetic Resonance System is a modification to the Signa Horizon CX Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa HFO/i MR System is an open style magnet operating at 0.7T. 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 than the Signa Profile System.
Mentions image processing
Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems.
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 HFO/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 The Signa HFO/i Magnetic Resonance System is equipment for medical diagnosis. Comparable to the Signa Horizon CX and the Signa Profile Magnetic Resonance Systems.
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.
The Signa Horizon Magnetic Resonance System
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.
Signa Profile 0.2T permanent magnet
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
Image /page/0/Picture/4 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' in a stylized font. The letters are intertwined and appear to be handwritten. The background of the circle is black, while the letters are white.
NOV - 9 1999
GE Medical Svstems
page 1 of 2
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
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, August 13, 1999
- p Identification of the Product Signa HFO/i Magnetic Resonance System
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
o Marketed Devices
The Signa HFO// Magnetic Resonance System is substantially equivalent to the currently marketed Signa Horizon Magnetic Resonance System with the main difference being a 0.7T Open Magnet while the Signa Horizon System has the typical 1.0T cylindrical magnet. The magnet looks like the Signa Profile 0.2T permanent magnet.
o Device Description
The Signa HFO/i Magnetic Resonance System is a modification to the Signa Horizon CX Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The Signa HFO/i MR System is an open style magnet operating at 0.7T. 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 than the Signa Profile System.
Indications for Use
o
The Signa HFO/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The HFO/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the HFO/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.
1
4145443863:
Image /page/1/Picture/3 description: The image shows a black and white logo of the General Electric (GE) company. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with flourishes, giving them a handwritten appearance. The overall design is simple and iconic, representing the brand identity of General Electric.
GE Medical Systems
page 2 of 2
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY QE SAFETY AND EFFECTIVENESS
Due to the 'open' design of the system, the HFO// may also be used for Imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
Comparison with Predicate 0
The Signa HFQ/i VH/i Magnetic Resonance System is comparable to the Signa Horizon CX and the Signa Profile Magnetic Resonance Systems with the main differences being the 0.7T Open Superconducting Magnet design.
o Summary of Studies
The Signa HFO// 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 The Signa HFO/i Magnetic Resonance System is equipment for medical diagnosis. comparable to the Signa Horizon CX and the Signa Profile Magnetic Resonance Systems.
o Conclusions
It is the opinion of GE that the Signa HFO/i Magnetic Resonance System is substantially equivalent to the Signa Horizon CX and the Signa Profile Magnetic Resonance Systems. The Signa HFO/i 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K992746 Signa HFO/I Magnetic Resonance System Dated: August 13, 1999 Received: August 16, 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). 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 (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 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 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: Signa HFO/i Magnetic Resonance System
Indications for Use:
The Signa HFO/i system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The HFO/i system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the HFO/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.
Due to the 'open' design of the system, the HFO/i may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)
David a. Segerson
(Division Sign-Off)
ivision of Reproductive, Abdominal, and Radiological De
510(k) Number K992746
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_