FDA.reportPublic FDA data

NA

Primary DI
00840682118989
Brand
NA
Company
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
Model
EXPRESS COIL - ANTERIOR ARRAY
Device description
1.5T Anterior Array,Express Coil
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging
LNISystem, nuclear magnetic resonance spectroscopic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103330000BRIVO MR355, OPTIMA MR360Ge Hangwei Medical Systems Co., Ltd.2011-02-11LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682118989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682118989008406821189898406821189890840682118989

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Sterilization Methods#

Method table
Method

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
00195278925282NASIGNA Sprint Select2026-05-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
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
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
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
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19