Who is the manufacturer of SIGNA Premier?

Ge Medical Systems, LLC filed the 510(k) submission for SIGNA Premier (K183231).

What is the FDA product code for SIGNA Premier?

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 Premier?

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

Does SIGNA Premier use AI or machine learning?

Yes. SIGNA Premier (K183231) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

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

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.

Can an AI/ML device like SIGNA Premier get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

SIGNA Premier

K183231 · Ge Medical Systems, LLC · LNH · Jan 18, 2019 · Radiology

Device Facts

Record ID	K183231
Device Name	SIGNA Premier
Applicant	Ge Medical Systems, LLC
Product Code	LNH · Radiology
Decision Date	Jan 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML

Intended Use

The SIGNA Premier 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 Premier 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 Premier is a 3.0T whole-body MRI scanner; features 70cm bore superconducting magnet. Input: magnetic resonance signals from patient anatomy. Transformation: system uses pulse sequences, imaging techniques, and reconstruction algorithms to generate axial, sagittal, coronal, oblique images, spectra, and parametric maps. New feature, AIRx, uses deep learning algorithms to automate/standardize brain MRI scan prescription steps. Operation: performed by trained clinicians/technicians in clinical settings. Output: diagnostic images/spectra viewed by physicians to assist in clinical diagnosis. Benefit: improved workflow, consistency, and patient comfort through automated scan setup.

Clinical Evidence

Internal clinical scans conducted to validate AIRx workflow. Results confirmed productivity and consistency benefits. MR system maintains imaging performance equivalent to predicate (K171128).

Technological Characteristics

3.0T superconducting magnet; 70cm bore. Complies with IEC 62304, ANSI/AAMI 60601-1, IEC 60601-2-33. Supports NEMA DICOM standards. Software feature (AIRx) utilizes deep learning algorithms for automated scan prescription.

Indications for Use

Indicated for diagnostic imaging of the entire body (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, musculoskeletal) to produce images, spectra, and parametric maps. Applicable to all patient populations requiring MRI; 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 Premier (K171128)

Related Devices

K193282 — SIGNA Premier · Ge Healthcare (Ge Medical Systems, LLC) · Apr 10, 2020
K171128 — SIGNA Premier · Ge Medical Systems, LLC · Jul 14, 2017
K253780 — SIGNA Bolt · Ge Medical Systems, LLC · Feb 6, 2026
K202238 — SIGNA Artist · Ge Healthcare (Tianjin) Company Limited · Sep 4, 2020
K253779 — SIGNA Sprint Select · Ge Medical Systems, LLC · Feb 5, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure. The FDA part of the logo has the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. GE Medical Systems, LLC % Mr. Brian R. Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd WAUKESHA WI 53188 January 18, 2019 Re: K183231 Trade/Device Name: SIGNA Premier Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI and MOS Dated: November 19, 2018 Received: November 20, 2018 Dear Mr. Zielski: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For 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) K183231 Device Name SIGNA Premier #### Indications for Use (Describe) The SIGNA Premier 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 region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Premier 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | <div> ☑ Prescription Use (Part 81 CFR 201 Subpart D) </div> | <div> ☐ Over-The-Counter Use (81 CFR 201 Subpart C) </div> | > 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/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are small, rounded shapes at the top and bottom of the circle, giving it a slightly decorative appearance. GE Healthcare 510(k) Premarket Notification Submission K183231 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | November 19, 2018 | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems, LLC (GE Healthcare) 3200 N. Grandview Blvd., Waukesha, WI 53188 USA | | Primary Contact Person: | Brian R. Zielski Regulatory Affairs Leader GE Healthcare Phone: 262-521-6609 | | Secondary Contact Person: | James McMahon Senior Director, Regulatory Affairs GE Healthcare Phone: 508-382-2858 | | Device Trade Name: | SIGNA Premier | | Common/Usual Name: | Magnetic Resonance Diagnostic Device | | Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 | | Product Code: | LNH, LNI, MOS | | Predicate Device(s): | SIGNA Premier (K171128) | | Device Description: | SIGNA Premier is a whole body magnetic resonance scanner designed to support high resolution, high signal- to-noise ratio, and short scan times, and is designed for improved patient comfort and workflow. The system features a 3.0T superconducting magnet with a 70cm bore size and can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system is designed to conform to NEMA DICOM | | | standards (Digital Imaging and Communications in Medicine). The modifications to this system include the AIRx software features, which allows users the flexibility to automate and standardize a number of connected steps required for an MRI examination of the brain. | | Indications for Use | The SIGNA Premier 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 Premier 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. | | Comparison of Indications for Use | The indications for use statement and intended use are identical to the predicate device, in accordance with the FDA's guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", dated 28 July 2014. | | Technology: | The SIGNA Premier with the proposed software feature employ the same fundamental technology as the predicate device. The SIGNA Premier has been modified to include the AIRx feature, which automates and standardizes a number of connected steps required for an MRI examination of the brain. AIRx was developed using deep learning algorithms. | | | These technological differences do not raise any different questions regarding safety and effectiveness. Both devices must allow for an effective method to setup an appropriate scan prescription. The performance data described in this submission include results of both bench testing and clinical testing that show the performance of the SIGNA Premier compared to the predicate device. | | Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: The modifications to SIGNA Premier include the AIRx software only feature and complies with the following voluntary standards: • IEC 62304 • ANSI/AAMI 60601-1 • IEC 60601-2-33 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 • Integration testing (System verification) • Performance testing (Verification) • Simulated use testing (Validation) The non-clinical tests have been summarized in the verification and validation testing for AIRx. The testing was completed with passing results per pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate because it was also developed under quality assurance Design Controls. In addition, the software complies with the same applicable Standards. | | | Summary of Clinical Tests: Internal scans were conducted as part of validation for AIRx workflow to confirm the productivity and consistency benefits of the proposed feature. The AIRx feature is a pre-scan algorithm, and the MR System | | | maintains the same imaging performance results as its predicate device (K171128). | | Conclusion: | The SIGNA Premier with the modified software feature has the same intended use as the predicate. This 510(k) submission includes information on the technological characteristics of the proposed software feature, as well as performance data demonstrating that the feature is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness. In conclusion, GE Healthcare considers the SIGNA Premier to be as safe, as effective, and performance is substantially equivalent to the predicate devices. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of a blue circle with a stylized, cursive "GE" in white inside. The "GE" letters are interconnected and have a flowing, elegant design. The blue circle has a slightly raised, rounded edge, giving it a three-dimensional appearance. GE Healthcare 510(k) Premarket Notification Submission {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The blue color is a vibrant, medium shade, and the cursive letters are white, creating a contrast that makes the logo easily recognizable. GE Healthcare 510(k) Premarket Notification Submission {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters, and the entire logo is in a light blue color. GE Healthcare 510(k) Premarket Notification Submission