Vitrea Software Package

GUDID 04987670105005

CANON MEDICAL SYSTEMS CORPORATION

Radiology PACS software

• Primary Device ID: 04987670105005
• NIH Device Record Key: 4c11c559-5b72-4183-914e-0a3f95a039fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea Software Package
• Version Model Number: VSTP-002A
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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: false
• Serial Number: true
• 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	04987670105005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223336

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: 2023-05-02
• Device Publish Date: 2023-04-24

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

• 04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM: 2024-07-15
• 04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM: 2024-07-15
• 04987670106095 - Aquilion Serve SP: 2024-07-12
• 04987670100925 - BIOPSY ADAPTOR: 2024-04-22
• 04987670104626 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104633 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104640 - ENDOCAVITARY TRANSDUCER: 2024-04-22
• 04987670104664 - CONVEX ARRAY TRANSDUCER: 2024-04-22