(26 days)
Not Found
No
The document describes a standard MRI system and its components, focusing on hardware and basic image processing ("reconstruction algorithms"). There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is described as a diagnostic imaging device designed to produce images and/or spectra that, when interpreted by a trained physician, assist in diagnosis, rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SIGNA Voyager is indicated for use as a diagnostic imaging device."
No
The device description explicitly details hardware components like a 1.5T superconducting magnet and a 70cm bore size, indicating it is a physical medical device, not software-only.
Based on the provided information, the SIGNA Voyager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- SIGNA Voyager Function: The SIGNA Voyager is a magnetic resonance scanner that produces images of the internal structures and organs of the entire body in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device" to produce images and spectra of internal structures.
- Device Description: The description details how it uses magnetic fields and RF transmissions to obtain information about elements exhibiting magnetic resonance within the body.
Therefore, the SIGNA Voyager falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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, 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.
Product codes
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
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 Voyager complies with the following voluntary standards:
• ANSI/AAMI ES60601-1
• IEC 60601-1-2
• IEC 60601-2-33
In addition, the SIGNA Voyager complies with the applicable NEMA MS standards for MRI as does 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 subject of this premarket submission, SIGNA Voyager, did not require clinical studies to support substantial equivalence.
Scanning of human subjects on the SIGNA Voyager system has been conducted at GE Healthcare facilities as part of design validation activities in order to ensure that the modified device meets user requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIGNA Voyager (K161567)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2019
GE Healthcare (Tianjin) Company Limited % Yuan Ma Regulatory Affairs Director No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin 300308 CHINA
Re: K192426
Trade/Device Name: SIGNA Voyager/ SIGNA Voyager Quantum Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: September 6, 2019 Received: September 9, 2019
Dear Yuan Ma:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
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combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name SIGNA Voyager / SIGNA Voyager Quantum
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, 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.
| 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) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 29, 2019 |
|---|---|
| Submitter: | GE Healthcare (Tianjin) Company Limited |
| No. 266 Jinjsan Road, Tianjin Airport Economic Area | |
| Tianjin, China | |
| Primary Contact | |
| Person: | Yuan Ma |
| Regulatory Affairs Director | |
| GE Healthcare (Tianjin) Company Limited | |
| Phone: +86 18101131106 | |
| Secondary Contact | |
| Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 262-521-6848 | |
| Device Trade Name: | SIGNA Voyager / SIGNA Voyager Quantum |
| 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 Voyager (K161567) |
| 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. | |
| 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. | |
| Technology: | The SIGNA Voyager employs the same fundamental scientific technology as |
| its predicate device. | |
| The SIGNA Voyager system has been modified by the introduction of a new | |
| IPM magnet configuration, in addition to the previously cleared LCCW | |
| magnet configuration. | |
| Determination of | |
| Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| Like the predicate device, the SIGNA Voyager complies with the following | |
| voluntary standards: | |
| • ANSI/AAMI ES60601-1 | |
| • IEC 60601-1-2 | |
| • IEC 60601-2-33 | |
| In addition, the SIGNA Voyager complies with the applicable NEMA MS | |
| standards for MRI as does 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 subject of this premarket submission, SIGNA Voyager, did not require | |
| clinical studies to support substantial equivalence. | |
| Scanning of human subjects on the SIGNA Voyager system has been | |
| conducted at GE Healthcare facilities as part of design validation activities in | |
| order to ensure that the modified device meets user requirements. | |
| Conclusion: | The Indications for Use of the SIGNA Voyager are identical to the predicate |
| device. The modifications to the SIGNA Voyager system do not change the | |
| fundamental scientific technology of the device. The results of design | |
| controls activities demonstrate that the SIGNA Voyager is substantially |
|
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