FDA.reportPublic FDA data

NA

Primary DI
00195278925282
Brand
NA
Company
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
Model
SIGNA Sprint Select
Device description
SIGNA Sprint Select System Medical Device
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging
LNISystem, Nuclear Magnetic Resonance Spectroscopic
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
LNISystem, Nuclear Magnetic Resonance SpectroscopicRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253779000SIGNA™ Sprint SelectGe Medical Systems, LLC2026-02-05LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278925282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278925282001952789252821952789252820195278925282

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Regulatory Flags#

DUNS number
421356265
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953089835NA7265300-52026-04-02
00198953089842NA7265300-62026-04-02
00195278577221NASIGNA Explorer2022-12-09
00195278577238NASIGNA Creator2022-12-09
00195278929518NASIGNA Sprint2025-09-26
00195278601162NASIGNA Prime Elite2025-04-15
00195278707871NASIGNA Champion2024-02-05
00195278629234NA7265300-22023-08-04
00195278616845NASIGNA Victor2023-03-10
00195278481382NASIGNA Artist Evo2022-09-08
00840682146302NASIGNA Prime2022-03-07
00195278372307NASIGNA Voyager AIR2021-06-15
00195278248923NA72653002021-04-26
00195278124609NASIGNA Voyager2021-02-02
00195278117021NASIGNA Artist2021-01-12
00195278126443NASIGNA Artist2021-01-12
00195278210036NASIGNA Artist2021-01-12
00840682108607NASIGNA VoyagerM70012TB2016-09-27
00840682113762NASIGNA Explorer2016-08-01
00840682113786NASIGNA Creator2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
B66910031MRIaudioPREM1003MRIAUDIO, INC.LNH2026-03-31
B66910041MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
00008848380988IngeniaPhilips Medical Systems Nederland B.V.LNI2025-10-01
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
08056304455055S-scan OpenESAOTE SPAMOS2023-12-14
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19
B237ZXLADK600Zephyr Patient Positioning and Transfer SystemDiacor, Inc.LNH2023-06-08
10841962119402Applicator Clamp HolderQfixLNH2023-05-05