(14 days)
Not Found
No
The document describes standard MR imaging technology and image reconstruction techniques (Fourier transformation) without mentioning any AI/ML components for image processing, analysis, or interpretation.
No
The device is described as a "diagnostic imaging device" intended to "assist in diagnosis," which indicates it is used for diagnostic purposes rather than therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device..." and later, "These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description clearly outlines a physical MR system with hardware components like a superconducting magnet, data acquisition system, and RF transmissions, not solely software.
Based on the provided information, the GE Signa® MR750 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- GE Signa® MR750 System Function: The description clearly states that the GE Signa® MR750 System is a magnetic resonance scanner that produces images of the internal structures and functions of the body. It works by using magnetic fields and radiofrequency transmissions to acquire data directly from the patient's body, not from specimens taken from the body.
- Intended Use: The intended use is described as a "diagnostic imaging device" to produce images and spectra that, when interpreted by a trained physician, may assist in diagnosis. This is consistent with in vivo imaging, not in vitro testing.
Therefore, the GE Signa® MR750 System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa® MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the 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 GE Signa® MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The 3.0T GE Signa® MR750 System is a new MR system that is substantially equivalent to previously cleared 3.0T MR systems. All utilize superconducting magnets to acquire 2D single-slice and 3D volume images. The 3.0T GE Signa® MR750 System features a superconducting magnet operating at 3.0Tesla. The data acquisition system accommodates up to 32 independent receive channels increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. 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. The 3.0T GE Signa® MR750 System is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
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)
Performance:
- Signal-to-noise ratio (SNR)
- Geometric distortion
- Image uniformity
- Slice thickness
- Spatial resolution
Safety
- Static field strength
- Acoustic noise
- DB/dt
- RF heating (SAR)
- Biocompatibility
The 3.0T MR750 MR system has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commencement of system production.
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.
GE 3.0T Signa® HDx Magnetic Resonance System (K052293), Siemens MAGNETOM Verio 3T Magnetic Resonance System (K072237)
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.
Not Found
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
GE Signa® MR750 M 510lk) Premarket Notification
GE Healthcare
510(k) Summary
This 510lk summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c.
| Submitter: | GE Healthcare Technologies
3200 N. Grandview Blvd.
Waukesha, WI 53188 | APR 25 2008 |
|-----------------|-----------------------------------------------------------------------------|-------------|
| Contact Person: | Mark M. Stauffer
Safety and Regulatory Engineer | |
| Telephone: | 262 - 521 - 6891 | |
| Fax: | 262 - 521 - 6379 | |
| Email: | Mark.X.Stauffer@ge.com | |
| Date Prepared: | 20 March 2008 | |
Device Name:
GE 3.0T Signa® MR750 System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Predicate Devices:
GE 3.0T Signa® HDx Magnetic Resonance System (K052293) Siemens MAGNETOM Verio 3T Magnetic Resonance System (K072237)
Device Description:
The 3.0T GE Signa® MR750 System is a new MR system that is substantially equivalent to previously cleared 3.0T MR systems. All utilize superconducting magnets to acquire 2D single-slice and 3D volume images. The 3.0T GE Signa® MR750 System features a superconducting magnet operating at 3.0Tesla. The data acquisition system accommodates up to 32 independent receive channels increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. 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. The 3.0T GE Signa® MR750 System is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Indications for Use:
The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa® MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TM.), spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
The images produced by the GE Signa® MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a troined physician yield information that may assist in diaqnosis.
1
GE Healthcare
GE Signa® MR750 MR System
. 510(k) Premarket Notification
The indications for use for the 3.0T GE Signa® MR750 System are similar to those for the Signa® HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.
Comparison with Predicate Devices:
The GE Signa® 3.0T MR750 System is a new device design that is similar to the previously cleared 3.0T HDx MR system (K052293) with the main differences being new receive chain architecture that will support up to 32 channels in various channel increments, an increase in the amplitude and slew rate of the gradient of the radio frequency amplifiers, an increased patient table weight limit, faster image reconstruction, and new system pockaging. The new receive chain architecture supports up to 32 independent receive channels and will accommodate expansion to 128 channels through future product development. The amplitude and slew rate of the gradient output has been increased relative to the predicate Signa® HDx system. The patient table has been designed to support up to five hundred pounds. Electrical components have been updated to minimize obsolescence issues. Also, the system packaging has incorporated watering cooling and has been designed to support the new receive channel architecture, improved gradients, and future expandability to 128 channels. The GE 3.0T Signa® MR750 System is comparable to the currently marketed 3.0T Signa® HDx MR System.
In addition to the hardware improvements made in the DV system, there are applications improvements that resulted from developmental work done to the feature set included with the HDx system. In most cases the features and applications in DV are significantly equivalent to those in HDx. In some instances the comparative fationale fføls ് Pratilizes a second predicate device, Siemens' MAGNETOM Verio 3T MR System, to which substantial equivalence is asserted.
Summary of Safety and Effectiveness Concerns:
As stated in the FDA document "Guidance for the Submission of Premarket Notifications for Magnetic Resorvance Diagnostic Devices" the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards (as referenced throughout this submission and listed in Tab A);
Performance:
-
Sianal-to-noise ratio (SNR) Geometric distortion Image uniformity Slice thickness Spatial resolution
Safety -
Static field strength Acoustic noise DB/dt RF heating (SAR) Biocompatibility
The 3.0T MR750 MR system has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commencement of system production.
Conclusion:
It is the opinion of GE that the GE 3.0T Signa® MR750 System is substantially equivalent to the 3.0T Signa® HDx MR System and Siemens' MAGNETOM Verio 3T MR System.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
GE Medical System, LLC c/o Mr. Jay Y. Kogoma Intertek Testing Services 2307 East Aurora Road Unit B7 TWINSBURG OH 44087
Re: K081028
Trade/Device Name: GE 3.0T Signa® MR750 System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 9, 2008 Received: April 11, 2008
Dear Mr. Kogoma:
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 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 (PMA), 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.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
NancyCbrogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
GE Healthcare
GE Signa® MR750 MR System 510{k) Premarket Notification
Indications for Use
510(k) Number (if known):
Device Name:
GE 3.0T Signa® MR750 System
Indications for Use:
The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the GE Signa® MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Prescription Use ਮ AND/OR (21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aogor Morthay
(Division Sign/Off Division of Reproductive, Abdominal and Radiological Devices K081028 510(k) Number