(86 days)
Not Found
No
The summary describes a standard MRI system and its capabilities, focusing on hardware specifications, imaging planes, and compliance with relevant standards. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is described as a diagnostic imaging device, used to produce images and spectra that assist in diagnosis, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SIGNA Voyager is indicated for use as a diagnostic imaging device." It also mentions that the images and/or spectra, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly states it is a "whole body magnetic resonance scanner" and mentions hardware components like a "1.5T superconducting magnet with a 70cm bore size." This indicates it is a hardware device with associated software, not a software-only medical device.
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. They are used to examine these samples outside of the body.
- Device Function: The SIGNA Voyager is a magnetic resonance scanner. It produces images of the internal structures and organs of the body by using magnetic fields and radiofrequency transmissions. This is an in vivo (within the living body) 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 and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body." This describes an imaging modality, not a test performed on a sample.
Therefore, the SIGNA Voyager falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 Voyager reflect the spatial distribution and/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, MOS
Device Description
The SIGNA Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. 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 and oblique planes, using various pulse sequences and reconstruction algorithms. The system is offered as a new system installation, in either a fixed or a mobile configuration. The system features A 1.5T superconducting magnet with a 70cm bore size.
Mentions image processing
Not Found
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 Voyager complies with the following voluntary standards:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-33
• ISO 10993-1
In addition, the SIGNA Voyager complies with the applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
The following quality assurance measures were applied to the development of the system, as they were for the predicates:
• 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 sample clinical images demonstrate the acceptable diagnostic imaging performance of the SIGNA Voyager including the additional enhanced software features and all coils. The image quality of SIGNA Voyager is substantially equivalent to that of the predicate device.
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.
SIGNA Pioneer (K160621), Optima MR450w 1.5T (DV25) (K142085)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Ge Healthcare Glen Sabin Regulatory Affairs Director 3200 N. Grandview Blvd Waukesha. Wisconsin 53188
Re: K161567
Trade/Device Name: Signa Voyager Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: June 3, 2016 Received: June 7, 2016
Dear Glen Sabin:
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 devicerelated 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/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,
Michael D.'Hara
For
Robert Ochs 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 Voyager
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161567
Device Name SIGNA Voyager
Indications for Use (Describe)
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-tonoise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 Voyager reflect the spatial distribution and/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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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FORM FDA 3881 (8/14)
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Section 5: 510(k) Summary
SIGNA Voyager
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Section 5: 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 03, 2016 |
|---|---|
| Submitter: | GE Healthcare |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188. USA | |
| Primary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6848 | |
| Secondary Contact Person: | Steve Kachelmeyer |
| Regulatory Affairs Director - MR | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: (262) 548-2432 | |
| Device Trade Name: | SIGNA Voyager |
| 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 (K160621) |
| Optima MR450w 1.5T (DV25) (K142085) | |
| Device Description: | The SIGNA Voyager system is a whole body magnetic |
| resonance scanner designed to support high resolution, high | |
| signal-to-noise ratio, and short scan times. 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 and oblique planes, using | |
| various pulse sequences and reconstruction algorithms. The | |
| system is offered as a new system installation, in either a fixed or | |
| a mobile configuration. The system features A 1.5T | |
| superconducting magnet with a 70cm bore size. |
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510(k) Premarket Notification Submission
| Intended Use: | The SIGNA Voyager is a whole body magnetic resonance
scanner designed to support high resolution, high signal-to-noise
ratio, and short scan time imaging. The SIGNA Voyager is
indicated for use as a diagnostic imaging device to produce axial,
sagittal, coronal, and oblique images, spectroscopic images
and/or spectra, dynamic images, and parametric maps of the
internal structures and organs of the entire body. Body structures
for evaluation include, but are 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 Voyager reflect the spatial
distribution and/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. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The SIGNA Voyager employs the same fundamental scientific
technology as its predicate devices.
The following is a summary of the different technology
characteristics from the predicate devices:
Updated RF Receive Chain New version of software Modified magnet and RF body coil Updated TDI Coil Suite New Computers |
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| Performance Data: | Summary of Non-Clinical Tests:
Like the predicate device, the SIGNA Voyager complies with the
following voluntary standards:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-33
• ISO 10993-1
In addition, the SIGNA Voyager complies with the applicable
NEMA MS standards for MRI and NEMA PS3 standard for
DICOM, as does the predicate device.
The following quality assurance measures were applied to the
development of the system, as they were for the predicates:
• 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 sample clinical images demonstrate the acceptable
diagnostic imaging performance of the SIGNA Voyager
including the additional enhanced software features and all coils.
The image quality of SIGNA Voyager is substantially equivalent
to that of the predicate device. |
| Conclusion: | The SIGNA Voyager has the same intended use as the predicate
devices. The differences in technological characteristics between
the SIGNA Voyager and the predicate devices do not raise any
different questions of safety or effectiveness. Performance data
provided in this submission demonstrate that the SIGNA
Voyager is as safe, as effective, and performs as well as or better
than the predicate devices.
GE Healthcare considers the SIGNA Voyager to be substantially
equivalent to the SIGNA Pioneer and Optima MR450w devices. |