CA1000

GUDID 00840682125260

GE HEALTHCARE

Radiology PACS software

• Primary Device ID: 00840682125260
• NIH Device Record Key: 537dcd2d-66e3-4780-ad40-05a056e10ece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CA1000
• Version Model Number: 2.0 SP 14
• 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	00840682125260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063628

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: 6
• Public Version Date: 2020-02-04
• Device Publish Date: 2017-10-18

Devices Manufactured by GE HEALTHCARE

• 00195278644039 - Universal Viewer: 2024-10-10 MD UV 8.1 MEDICAL DEVICE
• 00195278707741 - Digital Expert Access: 2024-07-01 DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
• 00840682124447 - Centricity: 2022-05-09 MD CPACS RA1000 4.0 MEDICAL DEVICE
• 00840682152754 - Graffiti: 2021-10-05 MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
• 00195278379610 - Universal Viewer: 2021-07-23 MD UV 8 MEDICAL DEVICE
• 00840682145558 - Centricity: 2020-02-14
• 00840682102681 - CENTRICITY: 2020-02-04
• 00840682102988 - CENTRICITY: 2020-02-04