GUDID 00195278248923

SIGNA Voyager 1.5T Detachable Table Assembly

GE Medical Systems (Tianjin) Co., Ltd.

Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet Full-body MRI system, superconducting magnet
Primary Device ID00195278248923
NIH Device Record Keyb905f609-4f7c-4b63-82e1-60b32aa4f7a4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7265300
Company DUNS421356265
Company NameGE Medical Systems (Tianjin) Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100195278248923 [Primary]

FDA Product Code

KXJTable, radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

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

00195278248923 - NA2021-05-04SIGNA Voyager 1.5T Detachable Table Assembly
00195278248923 - NA2021-05-04 SIGNA Voyager 1.5T Detachable Table Assembly
00195278124609 - NA2021-02-10 Kizuna System Medical Device Assembly-MDR
00195278117021 - NA2021-01-20 SIGNA Artist System Medical Device Assembly-MDR
00195278126443 - NA2021-01-20 SIGNA Artist Upgrade Medical Device- MDR
00195278210036 - NA2021-01-20 SIGNA Artist Upgrade Medical Device- MDD
00840682146104 - NA2019-12-24
00840682146814 - NA2019-11-26
00840682113786 - NA2019-03-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.