Who is the manufacturer of SIGNA Artist Evo?

Ge Healthcare (Tianjin) Company Limited filed the 510(k) submission for SIGNA Artist Evo (K213603).

What is the FDA product code for SIGNA Artist Evo?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SIGNA Artist Evo?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SIGNA Artist Evo?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIGNA Artist Evo

K213603 · Ge Healthcare (Tianjin) Company Limited · LNH · Feb 11, 2022 · Radiology

Device Facts

Record ID	K213603
Device Name	SIGNA Artist Evo
Applicant	Ge Healthcare (Tianjin) Company Limited
Product Code	LNH · Radiology
Decision Date	Feb 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The SIGNA™ Artist Evo system 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™ Artist Evo system 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.

Device Story

SIGNA Artist Evo is a whole-body magnetic resonance imaging (MRI) scanner; utilizes superconducting magnet, time-varying magnetic field gradients, and RF transmissions to acquire spatial/molecular data from nuclei. System supports up to 128 independent receive channels; processes data via pulse sequences and reconstruction algorithms to produce diagnostic images/spectra. Operated by trained clinicians in clinical settings; output interpreted by physicians to assist in diagnosis. Benefits include high signal-to-noise ratio and reduced scan times. Device incorporates new IRMW gradient coil while reusing existing 1.5T LCC magnet technology; software remains consistent with predicate with minor adjustments for hardware integration.

Clinical Evidence

No clinical studies were required. Substantial equivalence supported by non-clinical bench testing, including module verification, system integration, and performance testing. Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI 62304, NEMA MS standards, and ISO 10993 confirmed. Sample clinical images provided to demonstrate diagnostic image quality equivalent to the predicate.

Technological Characteristics

Whole-body MRI system; 1.5T superconducting magnet (LCC); IRMW gradient coil. RF transmit/receive subsystems unchanged from predicate. Connectivity via DICOM (NEMA PS3). Software-based reconstruction algorithms. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI 62304, ISO 10993.

Indications for Use

Indicated for use as a whole-body diagnostic MRI imaging device for patients requiring axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, or dynamic images of structures/functions including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. Contrast agents may be used.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

SIGNA Artist (K202238)

Reference Devices

SIGNA Architect (K202966)

Related Devices

K202238 — SIGNA Artist · Ge Healthcare (Tianjin) Company Limited · Sep 4, 2020
K143251 — SIGNA Creator, SIGNA Explorer · Ge Healthcare (Ge Medical Systems, LLC) · Feb 4, 2015
K251399 — SIGNA Sprint · Ge Medical Systems, LLC · Sep 11, 2025
K091536 — OPTIMA MR450W · Ge Medical Systems, LLC · Jul 17, 2009
K233728 — SIGNA Champion · Ge Healthcare (Tianjin) Company Limited · Jan 19, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ February 11, 2022 Image /page/0/Picture/1 description: The image shows 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. GE Healthcare (Tianjin) Company Limited % Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188 Re: K213603 Trade/Device Name: SIGNATM Artist Evo Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 12, 2021 Received: November 15, 2021 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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-reportingcombination-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 mediation-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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213603 Device Name SIGNA™ Artist Evo #### Indications for Use (Describe) The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support 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, neart, 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™ Artist Evo system reflect the spatial distribution or molecular environment of nuclej 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) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | ✘ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 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 border. There are decorative flourishes resembling water droplets or stylized leaves placed around the letters and along the inner edge of the circle. The background of the circle is a solid gray color, while the letters and decorative elements are white. # 510(k) Summary | | In accordance with 21 CFR 807.92 the following summary of information is provided: | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | November 12, 2021 | | Submitter: | GE Healthcare (GE Healthcare (Tianjin) Company Limited) No. 266 Jingsan Road, Tianjin Airport Economic Area Tianjin, China 300308 | | Primary Contact Person: | Qiang Ding Regulatory Affairs Program Manager Phone: +86 13311385163 Email: Ding.Qiang@ge.com | | Secondary Contact Person: | Glen Sabin Regulatory Affairs Director Phone: 262-894-4968 Email: Glen.Sabin@ge.com | | Device Trade Name: | SIGNA TM Artist Evo | | Common/Usual Name: | Magnetic Resonance Diagnostic Device | | Classification Names: | Magnetic Resonance Diagnostic Device | | Regulation Number: | 21 CFR 892.1000 | | Primary Product Code: | LNH | | Secondary Product Code: | LNI, MOS | | Predicate Device: | SIGNA TM Artist (K202238) | | Reference Device | SIGNA Architect (K202966) | | Device Description: | The SIGNA TM Artist Evo system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 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 system can image in the sagittal, coronal, axial, oblique, and double | {4}------------------------------------------------ |--| | | oblique planes, using various pulse sequences and reconstruction algorithms. | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Indications for Use statement for the proposed device is identical to that of the predicate device: The SIGNA™ Artist Evo system 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™ Artist Evo system 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 Characteristics: | Many of the technological characteristics of the proposed SIGNA™ Artist Evo system are unchanged from the predicate device. The SIGNA™ Artist Evo system reuses GE Healthcare 1.5T LCC magnets in the installed base, and introduces the new IRMW gradient coil. There are no changes to the RF transmit and receive subsystems compared to the predicate K202238. Key performance specifications (such as magnet stability and spatial homogeneity, maximum gradient strength, etc.) for the system are also unchanged. The SIGNA™ Artist Evo system also uses the same version software as the predicate device with some minor changes to accommodate the hardware differences. There are no changes to the pulse sequences, imaging protocols and image processing. | | Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: The SIGNA™ Artist Evo and the predicate device were subject to similar risk management activities and performance testing to demonstrate substantial equivalence of safety and performance. Testing included compliance to the following voluntary standards: AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 AAMI/ANSI 62304 | | | | | | In addition, the SIGNA™ Artist Evo was tested in accordance with applicable NEMA MS standards for MRI, and complies with the NEMA PS3 standard for DICOM, as does the predicate device. Both the SIGNA™ Artist Evo and the predicate device are compliant with ISO 10993. The following quality assurance measures were applied to the development of the subject device, as they were for the predicate device: | | | Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Simulated use testing (Validation) | | | Summary of Clinical Tests: The subject of this premarket submission, the SIGNAT™ Artist Evo, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Artist Evo in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on November 18, 2016. The image quality of the SIGNA™ Artist Evo is substantially equivalent to that of the predicate device. | | | Substantial Equivalence Conclusion: The indications for use of the proposed device are comparable to the claimed predicate device. The SIGNA™ Artist Evo employs equivalent technology to the claimed predicate device. Additionally, the results from the above non-clinical tests demonstrate that the device performs as intended. Therefore, the SIGNA™ Artist Evo is substantially equivalent to the predicate device to which it has been compared. | | Conclusion Drawn from Performance Testing: | The proposed SIGNA™ Artist Evo system has been developed under GE Healthcare's quality system and is at least as safe and effective as the legally marketed predicate. The performance testing did not identify any new hazards, adverse effects, or safety or performance concerns that are significantly different from those associated with MR imaging in general. Therefore, GE Healthcare believes that SIGNAT™ Artist Evo is substantially equivalent to the predicate device, and is safe and effective for its intended use. | {5}------------------------------------------------ Image /page/5/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 circle. There are four decorative flourishes or droplets evenly spaced around the outer edge of the circle. The logo is presented in a grayscale color scheme.