(322 days)
Not Found
No
The document describes a standard MRI system and its components, focusing on hardware and basic image acquisition/reconstruction techniques. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance summaries.
No
The device is described as a "diagnostic imaging device" intended to "assist in diagnosis" by producing images and spectra. It does not mention any therapeutic function or use in treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device."
No
The device description clearly details hardware components such as a superconducting magnet, data acquisition system, RF transmissions, RF transmit architecture, and a patient bore RF body coil, indicating it is a physical medical 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 Discovery MR750w 3.0T is a magnetic resonance scanner. It produces images of the internal structures and functions of the body using magnetic fields and radio waves. This is an in vivo (within the living body) diagnostic imaging technique, not an in vitro test.
- Intended Use: The intended use clearly states it is 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." This describes imaging, not laboratory testing of samples.
Therefore, the Discovery MR750w 3.0T falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Discovery MR750w 3.0T 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 Discovery MR750w 3.0T 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The Discovery MR750w 3.0T features a superconducting magnet operating at 3.0 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various 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 RF technology of the Discovery MR750w system integrates an RF transmit architecture designed to improve the overall image uniformity. This technology, called Multi-drive, optimizes RF transmit by adjusting the amplitude and phase of the RF output depending on the anatomy being scanned. In order to support Multi-Drive, the RF Transmit (Tx) chain is changed from MR750 and both Tx lines are divided into 2 lines with Dual output Exciter, Dual output RF amp, Dual Transmit/Receive Switch (DTRSW), dual UPM and a 70cm-wide patient bore RF body coil.
The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T is desianed 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 Imaging
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)
Non-Clinical Tests:
Measured and documented through testing to NEMA, IEC or ISO standards:
- Signal-to-noise ratio (SNR)
- Geometric distortion
- Image uniformity
- Slice thickness
- Spatial resolution-
Safety Tests:
- Static field strength
- Acoustic noise
- dB/dt
- RF heating (SAR)
- Biocompatibility
Clinical Tests:
Clinical images and clinical results summary demonstrate that the Discovery MR750w 3.0T maintains the same imaging performance results as the predicate systems of Discovery MR750, Optima MR450w. Refer to Section 20 for details of the studies performed.
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.
Discovery MR750 (K081028), Optima MR450w (K091536)
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
K103327
p1/3
Image /page/0/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a circular design with the letters "GE" in a stylized font in the center. The letters are surrounded by a circular border with four decorative swirls or flourishes evenly spaced around the circle. The logo is black and white.
Discovery MR750w 3.0T 510(k) Premarket Notification
SEP 3 0 2011
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 30, 2011 |
|---|---|
| Submitter: | GE Healthcare, (GE Healthcare Japan Corporation) |
| 7-127, Asahigaoka 4-chome, Hino-shi, | |
| Tokyo 191-8503 JAPAN | |
| Primary Contact Person: | Toru Shimizu |
| Regulatory Affairs Specialist | |
| GE Healthcare, (GE Healthcare Japan Corporation) | |
| Telephone: +81-42-585-5344 | |
| Fax: +81-42-585-5075 | |
| Secondary Contact | |
| Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Telephone: (262) 521-6848 | |
| Fax: (262) 521-6439 | |
| Device: Trade Name: | Discovery MR750w 3.0T |
| Common/Usual Name: | Magnetic Resonance Imaging System |
| Classification Names: | |
| Product Code: | Magnetic resonance diagnostic device |
| LNH | |
| Predicate Device(s): | Discovery MR750 (K081028) |
| Optima MR450w (K091536) | |
| Device Description: | The Discovery MR750w 3.0T features a superconducting |
| magnet operating at 3.0 Tesla. The data acquisition system | |
| accommodates up to 32 independent receive channels in | |
| various 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 RF technology of the Discovery MR750w system integrates | |
| an RF transmit architecture designed to improve the overall | |
| image uniformity. This technology, called Multi-drive, optimizes | |
| RF transmit by adjusting the amplitude and phase of the RF | |
| output depending on the anatomy being scanned. In order to | |
| support Multi-Drive, the RF Transmit (Tx) chain is changed from |
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are four decorative teardrop shapes placed symmetrically around the circle's perimeter. The logo is black and white.
Discovery MR750w 3.0T 510(k) Premarket Notification KI03327
p2/3
MR750 and both Tx lines are divided into 2 lines with Dual output Exciter, Dual output RF amp, Dual Transmit/Receive Switch (DTRSW), dual UPM and a 70cm-wide patient bore RF body coil.
The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750w 3.0T is desianed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The Discovery MR750w 3.0T is a whole body magnetic Intended Use: 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 Discovery MR750w 3.0T 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.
Technology: The Discovery MR750w 3.0T employs the same fundamental scientific technology as its predicate devices of Discovery MR750 and Optima MR450w. Refer to Section 12 for details of the Technical Comparison Table and the Application/Feature Comparison Chart.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
As stated in the FDA document "Guidance for the Submission of Premarket Notifications for Magnetic Resonance 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 Section 9:
2
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circle, and there are three decorative flourishes around the circle's perimeter.
Discovery MR750w 3.0T 510(k) Premarket Notification
Performance:
- Signal-to-noise ratio (SNR) .
- Geometric distortion .
- Image uniformity .
- Slice thickness .
- Spatial resolution-.
Safetv:
- Static field strength .
- Acoustic noise .
- dB/dt .
- . RF heating (SAR)
- Biocompatibility .
The tests outlined above have been executed with acceptable results. Refer to Section 15, 18 of this submission for the above performance and satety testing results.
The Discovery MR750w 3.0T has been designed to comply with applicable IEC standards as reference to Section 9, 17.
The device has been tested by a Nationally Recognized Testing Laboratory and certified to conform to applicable IEC, UL and CSA standards prior to commercialization of the system.
Numerical simulations were conducted to demonstrate the safety of the Multi-Drive RF transmit system.
The following quality assurance measures were applied to the development of the system as reference to Section 11, 16, 18:
- Risk Analysis and control �
- . Requirements Reviews
- Design Reviews .
・
- . Design Verification
- . Performance and Safety testing (Verification)
Summary of Clinical Tests:
Clinical images and clinical results summary demonstrate that the Discovery MR750w 3.0T maintains the same imaging performance results as the predicate systems of Discovery MR750, Optima MR450w. Refer to Section 20 for details of the studies performed.
Conclusion: GE Healthcare considers the Discovery MR750w 3.0T to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Toru Shimizu Regulatory Affairs Specialist GE Healthcare Japan Corporation 7-127, Asahigaoka 4-Chrome Hino-Shi, Tokyo, 191-8503 JAPAN
SEP 3 0 2011
Re: K103327
Trade/Device Name: Discovery MR750w 3.0T System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI and MOS Dated: September 2, 2011 Received: September 7, 2011
Dear Mr. Shimizu:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name:
Discovery MR750w 3.0T
Indications for Use:
The Discovery MR750w 3.0T 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 Discovery MR750w 3.0T 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 × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Spatzl
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)