SenoIris

GUDID 00840682140614

GE Healthcare GmbH

Diagnostic x-ray digital imaging system workstation
Primary Device ID00840682140614
NIH Device Record Key0780ad95-5ece-4cac-bcc8-934dd3859101
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenoIris
Version Model Number1
Company DUNS342492370
Company NameGE Healthcare GmbH
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
GS100840682140614 [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 Date2019-06-12
Device Publish Date2019-06-04

Devices Manufactured by GE Healthcare GmbH

00195278753472 - ViewPoint2024-07-23 ViewPoint 6 v6.15
00195278517340 - ViewPoint2023-10-18 ViewPoint 6 v6.14
00840682171953 - ViewPoint2020-08-31
00840682145718 - ViewPoint2020-01-10
00840682140614 - SenoIris2019-06-12
00840682140614 - SenoIris2019-06-12
00840682103640 - ViewPoint2019-05-23
00840682119610 - ViewPoint2019-05-23
00840682119627 - ViewPoint2019-05-23

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