(14 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard MRI technology components and functionalities.
No
The device is described as a "diagnostic imaging device" used to "produce images... when interpreted by a trained physician yield information that may assist in diagnosis." It does not mention any therapeutic use.
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 hardware components such as a superconducting magnet, RF receiver, and gradient systems, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- SIGNA Pioneer Function: The SIGNA Pioneer is a magnetic resonance scanner. It works by using magnetic fields and radio waves to create images of the inside of the body. This is an in vivo (within the living body) imaging technique.
- 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 the body directly, not testing samples taken from the body.
The description of the device and its intended use clearly align with an in vivo diagnostic imaging device, not an in vitro diagnostic device.
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 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 vield 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 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
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)
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:
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 modification that prompted this submission did not require
clinical testing.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
GE Healthcare % Mr. Andrew Menden Regulatory Affairs Manager 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K153003 Trade/Device Name: SIGNA Pioneer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: October 9, 2015 Received: October 13, 2015
Dear Mr. Menden:
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 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.
1
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/Resourcesfor You/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 Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
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 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 vield information that may assist in diagnosis.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by three swirling shapes, also in blue, that give the impression of movement or energy. The logo is simple, clean, and recognizable.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 9, 2015 |
|---|---|
| Submitter: | GE Healthcare, (GE Healthcare Japan Corporation) |
| 7-127, Asahigaoka 4-chome, Hino-shi, | |
| Tokyo 191-8503 JAPAN | |
| Primary Contact Person: | Andrew Menden |
| Regulatory Affairs Manager | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6223 | |
| Fax: 414-908-9585 | |
| 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: | SIGNA Pioneer (K143345) |
| 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 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. | |
| 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: | |
| 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 modification that prompted this submission did not require | |
| clinical testing. | |
| 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/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized font, enclosed within a blue circle. The circle has wave-like designs around the letters, giving it a dynamic and recognizable appearance. The logo is simple, clean, and easily identifiable.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a swirling design around the letters, giving it a dynamic and recognizable appearance.