The SIGNA™ Sprint Select 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 SIGNA™ Sprint Select 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 Description

SIGNA™ Sprint Select is a whole-body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet 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 oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

N/A

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.03

February 5, 2026

GE Medical Systems, LLC
Xinyu Song
Lead Specialist, Regulatory Affairs - MR
3200 N Grandview Blvd.
Waukesha, Wisconsin 53188

Re: K253779
Trade/Device Name: SIGNA™ Sprint Select
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: Class II
Product Code: LNH, LNI, MOS
Dated: November 26, 2025
Received: November 26, 2025

Dear Xinyu Song:

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 (the 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 available 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.

Page 2

K253779 - Xinyu Song
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K253779 - Xinyu Song
Page 3

assistance/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,

Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K253779

Please provide the device trade name(s).

SIGNA™ Sprint Select

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Page 5

SIGNA™ Sprint Select 510(k) Premarket Notification

510(k) Summary

K253779

In accordance with 21 CFR 807.92 the following summary of information is provided:

Field	Information
Date	January 29, 2026
Submitter	GE Medical Systems, LLC3200 N. Grandview Blvd.Waukesha, WI USA 53188
Primary Contact Person	Xinyu SongLead Specialist, Regulatory Affairs, MRGE HealthCarePhone: 86 186 1188 4503E-mail: Xinyu.Song@gehealthcare.com
Secondary Contact Person	Glen SabinDirector - Regulatory Affairs, MR StrategyGE HealthCarePhone: 262 894-4968E-mail: Glen.Sabin@gehealthcare.com
Device Trade Name	SIGNA™ Sprint Select
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	SIGNA™ Sprint (K251399)
Reference Device	(1) SIGNA™ Champion (K233728)(2) SIGNA™ Victor (K223439)

Reason for Submission:

This 510(k) is being submitted due to the introduction of SIGNA™ Sprint Select, a new 1.5T MR system from GE HealthCare.

Page 6

SIGNA™ Sprint Select 510(k) Premarket Notification

Device Description:

Key aspects of the system design:

• Two magnet options:

Demeter magnet, a 1.5T superconducting magnet with integral active shielding. It incorporates Freelium™ technology, enabling complete helium containment within a sealed system. The design eliminates the need of a quench pipe and includes automated ramp-up and ramp-down functionalities.
IPM magnet, using the same magnet as a conventional whole-body 1.5T system, with integral active shielding and a zero boil-off cryostat.

• A gradient coil that achieves up to 35 mT/m peak gradient amplitude and 140 T/m/s peak slew rate.

• Compatible with both 1.5T TDI Posterior Array and 1.5T AIR Posterior Array.

• A detachable patient table.

• A platform software with various PSD and applications, including the following AI features:

AIR™ Recon DL (Cleared in K213717).
Sonic DL™ (Cleared in K243667).
AIRx™ (Cleared in K183231). The AIRx™ has been modified to include spine and prostate anatomical regions, in addition to its existing functionality for brain and knee.
SIGNA One Camera: An AI-powered workflow that enables fast patient setup and automatic landmarking using a live camera feed.

Indications for Use

The SIGNA™ Sprint Select 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,

Page 7

SIGNA™ Sprint Select 510(k) Premarket Notification

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.

Comparison of Indications for Use

The changes in technology do not impact the indications for use. The indications for use have not been changed, other than to reflect the SIGNA™ Sprint Select product name. Therefore, the intended use is the same as 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™ Sprint Select employs the same fundamental scientific technology as its predicate device.

The SIGNA™ Sprint Select is built with two superconducting magnet options (Demeter magnet and IPM magnet), gradient, RF transmit architecture, RF receive chain and software application suite.

Comparison of Technological Characteristics

Overall, the SIGNA™ Sprint Select employs the same fundamental scientific technology and operating principles as the predicate device and reference devices.

There are some differences in characteristics between the proposed device and the predicate/reference devices, as summarized below:

Subsystem or Component	Predicate Device SIGNA™ Sprint (K251399)	Proposed Device SIGNA™ Sprint Select	Comments
Magnet	1.5T Superconducting Magnet with active shielding.	1.5T Superconducting Magnet with active shielding.	The proposed device offers two superconducting magnet options: the IPM magnet and the Demeter magnet.The IPM magnet is identical to the predicate device's magnet.The Demeter magnet is equivalent to the predicate device's magnet, and both the Demeter and IPM magnets have the same electromagnetic performance.

Page 8

SIGNA™ Sprint Select 510(k) Premarket Notification

Subsystem or Component	Predicate Device SIGNA™ Sprint (K251399)	Proposed Device SIGNA™ Sprint Select	Comments
Gradient Subsystem	A gradient coil with water-cooled, active-shielded design.	A gradient coil with water-cooled, active-shielded design.	The gradient subsystem of the proposed device is equivalent to that of the predicate device SIGNA™ Sprint and is identical to the gradient subsystem of the reference device SIGNA™ Champion.
RF Transmit Subsystem	1.5T Transmit with embedded body coil and local T/R coil.	1.5T Transmit with embedded body coil and local T/R coil.	The RF transmit subsystem, excluding the body coil, is identical to the predicate device, SIGNA™ Sprint.The body coil is identical to that of the reference device, SIGNA™ Champion.
RF Receive Subsystem	1.5T Direct Digital Interface (DDI) receive chain architecture.	1.5T Direct Digital Interface (DDI) receive chain architecture.	The RF receive subsystem is substantially equivalent to the predicate device, SIGNA™ Sprint, with an updated FPGA.
RF Coils – detachable	Comprehensive suite of 1.5T detachable coils for imaging all anatomies.	Comprehensive suite of 1.5T detachable coils for imaging all anatomies.	The detachable RF coils are identical to those of the predicate device, SIGNA™ Sprint, with additional compatible coil options.
RF Coil – embedded	1.5T AIR Posterior Array	1.5T TDI Posterior Array or 1.5T AIR Posterior Array	The 1.5T AIR Posterior Array coil is identical to the predicate device, SIGNA™ Sprint's PA coil.The 1.5T TDI Posterior Array coil was previously cleared under K161567.
Software Features	Comprehensive suite of software features, pulse sequences, and image processing applications to support MR imaging of all anatomies.	Comprehensive suite of software features, pulse sequences, and image processing applications to support MR imaging of all anatomies.	SIGNA™ Sprint Select uses equivalent software with predicate and reference devices.The base software platform of the proposed device has been modified from that of the predicate device to provide an updated user interface for the MR system.The proposed device software platform featuring various productivity enhancements that are designed to maximize workflow and reduce scan time.

Page 9

SIGNA™ Sprint Select 510(k) Premarket Notification

Subsystem or Component	Predicate Device SIGNA™ Sprint (K251399)	Proposed Device SIGNA™ Sprint Select	Comments
Gating Accessories	Respiratory peripheral and cardiac gating with wired or wireless connection.	Respiratory peripheral and cardiac gating with wired or wireless connection.	SIGNA™ Sprint Select uses gating accessories identical to those of the predicate device.

These differences do not raise any different questions regarding safety and effectiveness. Both devices must address questions of whether they provide an adequate level of image quality appropriate for diagnostic use. The performance data described in this submission include results of both bench testing and clinical testing that show the image quality performance of SIGNA™ Sprint Select compared to the predicate device.

Comparison of Operating Principles: The SIGNA™ Sprint Select functions using the same operating principles as the predicate device.

Comparison of Materials: The SIGNA™ Sprint Select and the predicate device both use flame retardant materials.

Comparison of Safety and Performance Testing: Both SIGNA™ Sprint Select and the predicate device comply with general and MR-specific safety and performance standards (see Determination of Substantial Equivalence below). SIGNA™ Sprint Select complies with IEC 60601-1 Edition 3.2 and IEC 60601-2-33 Edition 4.0, while the predicate device complies with earlier versions of these standards.

These technological differences do not raise any different questions regarding safety and effectiveness. Both devices must address questions of whether they provide an adequate level of image quality appropriate for diagnostic use. The performance data described in this submission include results of both bench testing and clinical testing that show the image quality performance of SIGNA™ Sprint Select compared to the predicate device.

Determination of Substantial Equivalence

Summary of Non-Clinical Tests:

The SIGNA™ Sprint Select and the predicate device were subject to similar risk management testing to demonstrate substantial equivalence of safety and performance.

The SIGNA™ Sprint Select offers two magnet options, and the safety and performance are equivalent between IPM and Demeter magnets.

Page 10

SIGNA™ Sprint Select 510(k) Premarket Notification

Testing to the following voluntary standards included:

Organization	Designation Number and Edition/Date
ANSI AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
IEC	60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
IEC	60601-2-33 Edition 4.0 2022-08
ANSI AAMI IEC	60601-1-2: 2014 [Including AMD 1:2021]
ANSI AAMI IEC	62304: 2006/A1:2016
ANSI AAMI ISO	10993-1: 2018
IEC	62464-1 Edition 2.0 2018-12
NEMA	MS-1-2008 (R2020)
NEMA	MS 2-2008 (R2020)
NEMA	MS 3-2008 (R2020)
NEMA	MS 4-2023
NEMA	MS 5-2018
NEMA	MS 8-2016 (R2003)
NEMA	PS 3.1 - 3.20 2023e

Both the SIGNA™ Sprint Select and the predicate device have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices.

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:

SIGNA™ Sprint Select did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission in accordance with the FDA

Page 11

SIGNA™ Sprint Select 510(k) Premarket Notification

Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on October 10, 2023.

A U.S. Board Certified radiologist reviewed these images and attested that images produced by SIGNA™ Sprint Select are of sufficient quality for diagnostic use.

Substantial Equivalence Conclusion:

The indications for use of the proposed device are comparable to the claimed predicate device. The SIGNA™ Sprint Select 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™ Sprint Select is substantially equivalent to the predicate device to which it has been compared.

Conclusion

In conclusion, GE HealthCare considers the SIGNA™ Sprint Select to be as safe, as effective, with performance that is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.