Xeleris Processing and Review System

GUDID 00840682152082

G E MEDICAL SYSTEMS ISRAEL LTD.

Nuclear medicine system workstation
Primary Device ID00840682152082
NIH Device Record Key19db4fb5-6ccb-49b0-a1ac-86e2e098d4e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameXeleris Processing and Review System
Version Model Number4 DR Virtualized
Company DUNS532102365
Company NameG E MEDICAL SYSTEMS ISRAEL LTD.
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
GS100840682152082 [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 Date2020-04-07
Device Publish Date2020-03-30

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

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