Digital Expert Access 5941611

GUDID 00195278707741

DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS

GE HEALTHCARE

MRI system application software
Primary Device ID00195278707741
NIH Device Record Keybb87777e-a4ec-4379-94e9-43a2b8324dc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Expert Access
Version Model Numberwith Remote scanning for MR
Catalog Number5941611
Company DUNS054324257
Company NameGE HEALTHCARE
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100195278707741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-01
Device Publish Date2024-06-21

Devices Manufactured by GE HEALTHCARE

00195278644039 - Universal Viewer2024-10-10 MD UV 8.1 MEDICAL DEVICE
00195278707741 - Digital Expert Access2024-07-01DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
00195278707741 - Digital Expert Access2024-07-01 DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
00840682124447 - Centricity2022-05-09 MD CPACS RA1000 4.0 MEDICAL DEVICE
00840682152754 - Graffiti2021-10-05 MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
00195278379610 - Universal Viewer2021-07-23 MD UV 8 MEDICAL DEVICE
00840682145558 - Centricity2020-02-14
00840682102681 - CENTRICITY2020-02-04
00840682102988 - CENTRICITY2020-02-04

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