Xeleris Processing and Review Workstation

GUDID 00840682134897

G E MEDICAL SYSTEMS ISRAEL LTD.

Nuclear medicine system workstation

• Primary Device ID: 00840682134897
• NIH Device Record Key: a1d91701-fe34-43d9-b6bf-531a522189cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xeleris Processing and Review Workstation
• Version Model Number: 4.1
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682134897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153355

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-30

On-Brand Devices [Xeleris Processing and Review Workstation]

• 00840682147545: 4.1450
• 00840682134897: 4.1
• 00840682109819: 4.0
• 00195278245021: Xeleris V Clinical Application SW