Volpara Scorecard

GUDID 09421904268333

VOLPARA HEALTH TECHNOLOGIES LIMITED

Radiological PACS software

• Primary Device ID: 09421904268333
• NIH Device Record Key: c87b266b-3450-49f4-9443-22fcbbfa5a79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volpara Scorecard
• Version Model Number: 4.5
• Company DUNS: 590762212
• Company Name: VOLPARA HEALTH TECHNOLOGIES LIMITED
• 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: true
• 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	09421904268333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211279

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: 2025-05-14
• Device Publish Date: 2025-05-06

Devices Manufactured by VOLPARA HEALTH TECHNOLOGIES LIMITED

• 09421904268333 - Volpara Scorecard: 2025-05-14
• 09421904268333 - Volpara Scorecard: 2025-05-14
• 09421904268340 - Volpara Live: 2025-05-14
• 09421904268241 - VolparaDensity: 2020-10-09
• 09421904268265 - VolparaDoseRT: 2020-10-02 VolparaDoseRT 3.4.2
• 09421904268272 - VolparaDoseSR: 2020-10-02 VolparaDoseSR 3.4.2
• 09421904268289 - Volpara Density Map: 2020-10-02 Volpara Density Map 3.4.2
• 09421904268296 - VolparaDoseRT: 2020-10-02 VolparaDoseRT 4.0
• 09421904268302 - VolparaDoseSR: 2020-10-02 VolparaDoseSR 4.0