GUDID 00840682145954

GENERAL ELECTRIC COMPANY

PET/MRI system
Primary Device ID00840682145954
NIH Device Record Keya8c736c1-504d-4ce8-8d21-5380c5a5fa47
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSIGNA PET MR SPiCE Workstation
Company DUNS160032025
Company NameGENERAL ELECTRIC COMPANY
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
GS100840682145954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUOTomographic imager combining emission computed tomography with nuclear magnetic resonance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-30
Device Publish Date2020-06-22

Devices Manufactured by GENERAL ELECTRIC COMPANY

00195278729224 - NA2023-09-28 PETMR PGR Upgrade Kit, MP24 to MP30
00195278648877 - NA2023-09-27 SIGNA PETMR System Medical Device Assembly - MDR
00195278596628 - NA2022-08-31 SIGNA Premier 3.0T Detachable Table Assembly- Wireless Gating
00195278596642 - NA2022-08-31 SIGNA Hero 3T Detachable Table Assembly- Wireless Gating
00195278486813 - NA2022-02-21 SIGNA Hero System Medical Device Assembly - MDR
00195278472083 - NA2022-01-10 SIGNA Hero 3T Detachable Table Assembly
00195278122643 - NA2021-05-18 1.5T Signa HDxt Upgrade Kit Medical Device, MDR
00195278005502 - NA2020-08-24

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