(29 days)
No
The document describes a standard MR imaging system and its technical specifications, focusing on hardware and traditional image reconstruction techniques (Fourier transformation). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies summary.
No.
The device is described as a diagnostic imaging device used to produce images that assist in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Signa® HDx MR system is indicated for use as a diagnostic imaging device".
No
The device description explicitly states it is a "whole body magnetic resonance scanner" and details hardware components like a superconducting magnet, data acquisition system, and receive channels. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the GE Signa® HDx MR system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Signa® HDx MR system is a diagnostic imaging device that produces images of the internal structures and organs of the entire body. It works by detecting the spatial distribution of protons within the body, not by analyzing samples taken from the body.
- The device description focuses on the physical components and imaging capabilities. It describes the magnet, data acquisition system, and imaging techniques, all of which are related to capturing images in vivo (within the living body).
- The performance studies mentioned are related to safety and performance standards for medical imaging equipment. They are not studies evaluating the accuracy of analyzing biological samples.
Therefore, the GE Signa® HDx MR system is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
LNH
Device Description
The 1.5T and 3.0T Signa® HDx MR systems are a modification to the previously cleared MR systems K041476 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T and 3.0T Signa® HDx Magnetic Resonance System features a superconducting magnet operating at either 1.5T, or 3.0T. The data acquisition system supports 1, 4, 8, 12, 16, 32 independent receive channels and multiple independent coil elements per channel during a single acquisition series. Additionally, the system architecture is designed for expansion in 16 channel increments. 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, short scan times, and multinuclear spectroscopy. The 1.5T Signa® HDx MR system is also available in a mobile configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the 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 1.5T and 3.0T Signa® HDx Magnetic Resonance Systems were evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60061-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The 1.5T Signa® HDx Magnetic Resonance System is comparable to the currently marketed Signa® Excite 1.5T Magnetic Resonance System. The 3.0T Signa® HDx Magnetic Resonance System is comparable to the currently marketed Signa® Excite 3.0T Magnetic Resonance System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
GE Healthcare Technologies
SEP 2 1 2005
P.O. Box 414, Milwaukee, WI 53201
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Healthcare Technologies
PO Box 414
Milwaukee, WI 53201 |
|-----------------|-----------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | August 22, 2005 |
Device Name:
GE 1.5T Signa® HDx MR System, and GE 3.0T Signa® HDx MR System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The 1.5T Signa® HDx MR System is substantially equivalent to the currently marketed Signa® Excite 1.5T MR system (K041476) with the main differences being a change to the receive chain architecture that includes thirty two independent receive channels, and allows for future expansion in 16 channel increments.
The 3.0T Signa® HDx MR System is substantially equivalent to the currently marketed Signa Excite 3.0T MR system (K041476) with the main differences being a change to the receive chain architecture that includes thirty two independent receive channels, and allows for future expansion in 16 channel increments.
Device Description:
The 1.5T and 3.0T Signa® HDx MR systems are a modification to the previously cleared MR systems K041476 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T and 3.0T Signa® HDx Magnetic Resonance System features a superconducting magnet operating at either 1.5T, or 3.0T. The data acquisition system supports 1, 4, 8, 12, 16, 32 independent receive channels and multiple independent coil elements per channel during a single acquisition series. Additionally, the system architecture is designed for expansion in 16 channel increments. 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 anafomical applications, short scan times, and multinuclear spectroscopy. The 1.5T Signa® HDx MR system is also available in a mobile configuration.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and connected, creating a unique and recognizable design. The logo is black and white.
P.O. Box 414, Milwaukee, WI 53201
Indications for Use:
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDx MR svstem is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and obligue images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Comparison with Predicate Device:
The 1.5T and 3.0T Signa® HDx MR Systems are a modification of the previously cleared MR systems K041476 with the main differences being the receive chain architecture that includes a thirty two independent receive channels, and allows for future expansion in 16 channel increments. The overall system has been improved with a simplified User Interface and a single 23" Liquid Crystal Display, improved multi-channel surface coil connectivity, and an improved image reconstruction architecture known as the Volume Recon Engine (VRE).
Summary of Studies:
The 1.5T and 3.0T Signa® HDx Magnetic Resonance Systems were evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60061-2-33 Particular Requirements for Safety of Macnetic Resonance Equipment for Medical Diagnosis. The 1.5T Signa® HDx Magnetic Resonance System is comparable to the currently marketed Signa® Excite 1.5T Magnetic Resonance System. The 3.0T Signa® HDx Magnetic Resonance System is comparable to the currently marketed Signa® Excite 3.0T Magnetic Resonance System.
Conclusion:
It is the opinion of GE that the 1.5T Signa® HDx Magnetic Resonance System is substantially equivalent to the Signa® Excite 1.5T Magnetic Resonance System. Usage of the 1.5T Signa HDx Magnetic Resonance System does not result in any new potential hazards.
It is the opinion of GE that the 3.0T Signa® HDx Magnetic Resonance System is substantially equivalent to the Signa® Excite 3.0T Magnetic Resonance System. Usage of the 3.0T Signa HDx Magnetic Resonance System does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The logo is encircled by text that reads "DEPARTMENT OF HUMAN". The text is arranged in a circular fashion around the bird, with the words "DEPARTMENT" and "HUMAN" being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2005
Larry A. Kroger, Ph.D.. Senior Regulatory Programs Manager GE Healthcare Technologies P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K052293
Trade/Device Name: GE 1.5T and 3.0T Signa® HDx MR Systems Regulation Number: 21 CFR $892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 22, 2005 Received: August 23, 2005
Dear Dr. Kroger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 enactnent 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in black against a white background.
GE Healthcare Technologies
P.O. Box 414, Milwaukee, WI 53201
Indications for Use
Kos2193 510(k) Number (if known): _
Device Name:
GE 1.5T Signa® HDx MR System, and GE 3.0T Signa® HDx MR System
Indications for Use:
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diaqnosis.
Prescription Use × (Part 21 CFR 80.1 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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