Centricity

GUDID 00840682124447

MD CPACS RA1000 4.0 MEDICAL DEVICE

GE HEALTHCARE

Radiology PACS software

• Primary Device ID: 00840682124447
• NIH Device Record Key: f82eb2c8-9e5f-4a2a-925a-584bfc08fbb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centricity
• Version Model Number: CPACS RA1000 4.0
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682124447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110875

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-29

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