(16 days)
No
The summary 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 provided text.
No
The device is described as a "diagnostic imaging device" intended to "assist in diagnosis" by producing images, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use as a diagnostic imaging device." It also mentions that the images and/or spectra produced "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description clearly outlines a hardware system including a superconducting magnet, data acquisition system, and coils, which are physical components, not software-only.
Based on the provided information, the GE Signa® HDe MR system 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 GE Signa® HDe MR system is a diagnostic imaging device that uses magnetic resonance to produce images of the internal structures of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for producing images and spectra of internal structures and organs to assist in diagnosis when interpreted by a trained physician. This is a form of in vivo (within the living body) diagnostic imaging.
Therefore, the GE Signa® HDe MR system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GE Signa® HDe 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® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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® HDe 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 Signa® HDe MR systems are a modification to the previously cleared MR systems K052293 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T Signa® HDe Magnetic Resonance System features a superconducting magnet operating at 1.5T. The data acquisition system supports 1, 4, 8 independent receive channels and multiple independent coil elements per channel during a single acquisition series. 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 short scan times. The 1.5T Signa® HDe MR system is also compatible in a mobile configuration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Whole 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The 1.5T Signa® HDe Magnetic Resonance Systems were evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety portomianos claimatian Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis.
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.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, set against a white background.
- 9 2005
GE Healthcare
P.O. Box 414, Milwaukee, WI 53201
Image /page/0/Picture/4 description: The image shows the text "K05 2978" in a handwritten style, followed by the text "510(k) Summary" in a more formal font. The numbers and letters in the first line are bold and slightly distorted, while the second line is clear and legible. The text appears to be part of a document or label, possibly related to a medical device or regulatory submission.
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
PO Box 414
Milwaukee, WI 53201 |
|-----------------|-------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Senior Regulatory Programs Manager |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | October 18, 2005 |
Device Name:
GE 1.5T Signa® HDe MR System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The 1.5T Signa® HDe MR System is substantially equivalent to the currently marketed GE 1.5T AND 3.0T Signa® HDx MR SYSTEM (K052293) with the main differences being a change to the receive chain architecture that includes fully digital eight independent receive channels.
Device Description:
The 1.5T Signa® HDe MR systems are a modification to the previously cleared MR systems K052293 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T Signa® HDe Magnetic Resonance System features a superconducting magnet operating at 1.5T. The data acquisition system supports 1, 4, 8 independent receive channels and multiple independent coil elements per channel during a single acquisition series. 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 short scan times. The 1.5T Signa® HDe MR system is also compatible in a mobile configuration.
Indications for Use:
The GE Signa® HDe 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® HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, 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 images produced by the Signa® HDe system reflect the spatial distribution of protons (hydrogen nuclei)
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized font, enclosed within a circular frame. The frame has decorative elements resembling leaves or swirls around the circle.
P.O. Box 414, Milwaukee, WI 53201
exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Comparison with Predicate Device:
The 1.5T Signa® HDe MR Systems are a modification of the previously cleared MR systems rne 1.9 - Signa - HD6 milferences being the change to the receive chain architecture that includes fully digital eight independent receive channels.
Summary of Studies:
The 1.5T Signa® HDe Magnetic Resonance Systems were evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety portomianos claimatian Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The 1.5T Signa® HDe Magnetic Resonance System is Equipment for Modiour Diagnesis: The Tro Tro Tro Tro Trans HDx MR SYSTEM.
Conclusion:
It is the opinion of GE that the 1.5T Signa® HDe Magnetic Resonance System is substantially it is the opinion of GE 1.5T AND 3.0T Signa® HDx Magnetic Resonance System. Usage of the 1.5T Signa® HDe Magnetic Resonance System does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three parallel lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE HEALTHCARE 3200 Grandview Boulevard WAUKESHA WI 53188
K052978 Re.:
NOV - 9 2005
Trade/Device Name: GE. 1.5T Signa HDe MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 18, 2005 Received: October 24, 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 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) that do not require approval of a premarket approval (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 (PMA), it may be subject to 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) I mis icities will anow you to ough tinding of substantial equivalence of your device to a legally premarked predicated 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 If you desire specific actrice for your are 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 Allo, production other general information on your responsibilities under the Act from the 001:37). " ou may overnment oners, 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. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
P.O. Box 414. Milwaukee, WI 53201
Indications for Use
510(k) Number (if known): 60529178
Device Name:
GE 1.5T Signa® HDe MR System
Indications for Use:
The GE Signa® HDe 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® HDe oupport high roosiation first rely as a diagnostic imaging device to produce axial sagittal, w reyecent loblique images, 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® HDe 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.
Prescription Use (Part 21 CFR 801 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)
Nancy C. Boykin
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052978
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