MR Contour DL 5986345

GUDID 00198953043387

MD MR Contour DL v1.0

GE HEALTHCARE

Radiation therapy software
Primary Device ID00198953043387
NIH Device Record Key0e2db8d7-8d89-4134-80c4-8c33f842b9de
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Contour DL
Version Model Number1
Catalog Number5986345
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
GS100198953043387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKBRadiological Image Processing Software For Radiation Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-02
Device Publish Date2026-01-23

Devices Manufactured by GE HEALTHCARE

00198953043387 - MR Contour DL2026-02-02MD MR Contour DL v1.0
00198953043387 - MR Contour DL2026-02-02 MD MR Contour DL v1.0
00195278644039 - Universal Viewer2024-10-10 MD UV 8.1 MEDICAL DEVICE
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

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