CENTRICITY

GUDID 00840682103800

GE HEALTHCARE

Medical image management system

• Primary Device ID: 00840682103800
• NIH Device Record Key: 089dc7ab-2f1c-42fe-b13a-e1587ca8bb70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CENTRICITY
• Version Model Number: UNIVERSAL VIEWER 6.0
• Company DUNS: 054324257
• Company Name: GE HEALTHCARE
• 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	00840682103800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150420

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: 5
• Public Version Date: 2020-02-04
• Device Publish Date: 2016-08-01

On-Brand Devices [CENTRICITY]

• 00840682104821: CPACS RA1000 6.0
• 00840682145794: UNIVERSAL VIEWER 7.0
• 00840682145572: CPACS 7.0
• 00840682141642: Perinatal 6.98
• 00840682124430: CPACS 4.0
• 00840682123785: Perinatal6.97
• 00840682104807: CPACS 6.0
• 00840682103800: UNIVERSAL VIEWER 6.0
• 00840682102988: UNIVERSAL VIEWER ZFP CLIENT 6.0
• 00840682102681: PERINATAL6.96
• 00840682145558: CPACS 7.0
• 00840682124447: MD CPACS RA1000 4.0 MEDICAL DEVICE