Synthesis Vision Viewer

GUDID 75401622502219

Synthesis Health Intelligence Inc

Radiological PACS software

• Primary Device ID: 75401622502219
• NIH Device Record Key: 06a04888-d4b2-4a4f-9646-ed2e8552eac1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthesis Vision Viewer
• Version Model Number: 2.1
• Company DUNS: 243267198
• Company Name: Synthesis Health Intelligence Inc
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	75401622502219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240724

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: 2025-08-28
• Device Publish Date: 2025-08-20

On-Brand Devices [Synthesis Vision Viewer]

• 75401622500208: 1.0.0
• 75401622502202: 2.0
• 75401622502219: 2.1
• 75401622502226: 2.2