CA1000

GUDID 00840682125260

GE HEALTHCARE

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device ID00840682125260
NIH Device Record Key537dcd2d-66e3-4780-ad40-05a056e10ece
Commercial Distribution StatusIn Commercial Distribution
Brand NameCA1000
Version Model Number2.0 SP 14
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
GS100840682125260 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-04
Device Publish Date2017-10-18

Devices Manufactured by GE HEALTHCARE

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
00840682103800 - CENTRICITY2020-02-04
00840682104807 - Centricity2020-02-04

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