(231 days)
Discovery MR750w 3.0T (K142085)
No
The summary describes a standard MRI scanner and its technical specifications, focusing on hardware and basic image reconstruction. There is no mention of AI, ML, or any features that would typically involve such technologies for image analysis, interpretation, or workflow optimization.
No.
The device is indicated for diagnostic imaging to assist in diagnosis, not for therapy.
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 outlines significant hardware components including a superconducting magnet, RF receiver, and data acquisition system, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the SIGNA Pioneer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The SIGNA Pioneer is a magnetic resonance scanner that directly images the human body.
- The intended use describes imaging the structures of the entire body. This is in vivo imaging, not in vitro (in glass/outside the body).
- The device description details a whole body magnetic resonance scanner. This is consistent with in vivo imaging.
The SIGNA Pioneer is a diagnostic imaging device used for in vivo examination of the human body.
N/A
Intended Use / Indications for Use
The SIGNA Pioneer 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 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 SIGNA Pioneer 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
LNH, MOS
Device Description
The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm bore size.
The RF receiver is equipped with 97 RF channels. The data acquisition system accommodates 32 channels for image reconstruction simultaneously.
The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance.
The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.
The SIGNA Pioneer uses multi-drive RF transmit for imaging of the head and body regions.
The SIGNA Pioneer is designed to conform to NEMA DICOM standards.
Mentions image processing
Yes
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)
Summary of Non-Clinical Tests:
Like the predicate device, the SIGNA Pioneer complies with the following voluntary standards:
IEC 60601-1 IEC 60601-1-2 IEC 60601-2-33 ISO 10993-1
In addition, the SIGNA Pioneer complies with the applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
The SIGNA Pioneer has been verified to meet the same safety criteria as the predicate device for local SAR for various anatomies. This verification was done by using local SAR human modeling simulations for RF multi drive transmit, as was done for the predicate device.
The following quality assurance measures were applied to the development of the system, as they were for the predicate:
Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
Summary of Clinical Tests:
The clinical images and clinical results summary demonstrate the acceptable diagnostic imaging performance of the SIGNA Pioneer including the additional new software features and TDI coil suite.
The image quality of SIGNA Pioneer is substantially equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Discovery MR750w 3.0T (K142085)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
GE Healthcare Japan Corporation % Toru Shimizu Regulatory Affairs Specialist 7-127, Asahigaoka 4-chome Hino-shi, Tokyo 191-8503 JAPAN
Re: K143345
Trade/Device Name: SIGNA Pioneer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: June 19, 2015 Received: June 22, 2015
Dear Toru Shimizu:
This letter corrects our substantially equivalent letter of July 10, 2015.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
SIGNA Pioneer
3
Indications for Use
510(k) Number (if known)
Device Name SIGNA Pioneer
Indications for Use (Describe)
The SIGNA Pioneer 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 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 SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary
SIGNA Pioneer
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 7, 2015 |
|---|---|
| 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 - Product | |
| GE Healthcare, (GE Healthcare Japan Corporation) | |
| Phone: +81-42-585-5344 | |
| Fax: +81-42-585-5911 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director - MR | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6848 | |
| Device Trade Name: | SIGNA Pioneer |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 |
| Product Code: | LNH, MOS |
| Predicate Device: | Discovery MR750w 3.0T (K142085) |
| Device Description: | The SIGNA Pioneer features a 3.0T superconducting magnet with |
| a 70cm bore size. | |
| The RF receiver is equipped with 97 RF channels. The data | |
| acquisition system accommodates 32 channels for image | |
| reconstruction simultaneously. | |
| The system uses a combination of time-varying magnetic fields | |
| (gradients) and RF transmissions to obtain information regarding | |
| the density and position of nuclei exhibiting magnetic resonance. | |
| The system can image in the sagittal, coronal, axial, oblique, and | |
| double oblique planes, using various pulse sequences and | |
| reconstruction algorithms. | |
| The SIGNA Pioneer uses multi-drive RF transmit for imaging of | |
| the head and body regions. | |
| The SIGNA Pioneer is designed to conform to NEMA DICOM | |
| standards. | |
| Intended Use: | The SIGNA Pioneer 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 SIGNA Pioneer 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 SIGNA Pioneer employs the same fundamental scientific |
| technology as its predicate device. | |
| The following is a summary of the different technology | |
| characteristics from the predicate device: | |
| Newly designed gradient system and RF receive chain including DDI and DST Addition of new software features including Auto Navigator tracker placement, Auto Protocol Optimization and enhanced Image filter TDI Coil Suite including DMS | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| Like the predicate device, the SIGNA Pioneer complies with the | |
| following voluntary standards: | |
| IEC 60601-1 IEC 60601-1-2 IEC 60601-2-33 ISO 10993-1 | |
| In addition, the SIGNA Pioneer complies with the applicable | |
| NEMA MS standards for MRI and NEMA PS3 standard for | |
| DICOM, as does the predicate device. | |
| The SIGNA Pioneer has been verified to meet the same safety | |
| criteria as the predicate device for local SAR for various | |
| anatomies. This verification was done by using local SAR human | |
| modeling simulations for RF multi drive transmit, as was done for | |
| the predicate device. | |
| The following quality assurance measures were applied to the | |
| development of the system, as they were for the predicate: | |
| Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) | |
| Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) Summary of Clinical Tests: | |
| The clinical images and clinical results summary demonstrate the | |
| acceptable diagnostic imaging performance of the SIGNA Pioneer | |
| including the additional new software features and TDI coil suite. | |
| The image quality of SIGNA Pioneer is substantially equivalent to | |
| that of the predicate device. | |
| Substantial Equivalence Conclusion: | |
| The Indications for Use of the SIGNA Pioneer are identical to the | |
| predicate device. The results from the above Non-Clinical and | |
| Clinical Tests demonstrate that the SIGNA Pioneer is substantially | |
| equivalent to the predicate with regards to safety and efficacy. | |
| Conclusion: | GE Healthcare considers the SIGNA Pioneer to be as safe, as |
| effective, and performance is substantially equivalent to the | |
| predicate device. |
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle has wave-like designs around it, giving it a dynamic and fluid appearance. The logo is presented in a blue color, which is consistent with GE's branding.