GUDID 00195278707871

SIGNA Champion System Medical Device

GE Medical Systems (Tianjin) Co., Ltd.

Full-body MRI system, superconducting magnet
Primary Device ID00195278707871
NIH Device Record Key051bdb4b-3942-4327-a9dd-609c3065287f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSIGNA Champion
Company DUNS421356265
Company NameGE Medical Systems (Tianjin) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278707871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNISystem, nuclear magnetic resonance spectroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

Devices Manufactured by GE Medical Systems (Tianjin) Co., Ltd.

00195278707871 - NA2024-02-13SIGNA Champion System Medical Device
00195278707871 - NA2024-02-13 SIGNA Champion System Medical Device
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00195278616845 - NA2023-03-20 SIGNA Victor System Medical Device
00195278481382 - NA2022-09-16 SIGNA Artist Evo System Medical Device, MDR
00840682146302 - NA2022-03-15 SIGNA Prime System Medical Device
00195278372307 - NA2021-06-23 Voyager AIR Medical Device Assembly
00195278248923 - NA2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly
00195278124609 - NA2021-02-10 Kizuna System Medical Device Assembly-MDR

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