FDA.reportPublic FDA data

NA

Primary DI
00840682108607
Brand
NA
Company
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
Model
SIGNA Voyager
Catalog number
M70012TB
Device description
Kizuna System Medical Device Assembly
Published
2016-09-27
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
MOSCoil, magnetic resonance, specialty

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121676000
K161567000
K192426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1216760001.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC2012-09-20LNH
K161567000SIGNA VoyagerGE Healthcare2016-09-01LNH
K192426000Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited2019-10-01LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682108607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682108607008406821086078406821086070840682108607

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.

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
00840682113762NASIGNA Explorer2016-08-01
00840682113786NASIGNA Creator2016-08-01

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
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
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
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
04260486610483NHAC 1.5T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610537NHAC 3.0T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610582NBAC 1.5T PH I SpineLMT Medical Systems GmbHMOS2024-04-23
04260486610599NBAC 3.0T PH I SpineLMT Medical Systems GmbHMOS2024-04-23