Volpara Density Map

GUDID 09421904268289

Volpara Density Map 3.4.2

VOLPARA HEALTH TECHNOLOGIES LIMITED

Radiology PACS software

• Primary Device ID: 09421904268289
• NIH Device Record Key: 3e0cbc26-b8f2-43d7-a1ad-b959b0250c2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Volpara Density Map
• Version Model Number: 3.4.2
• 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: 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	09421904268289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153427

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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [Volpara Density Map]

• 09421904268128: Volpara Density Map 3.3
• 09421904268050: Volpara Density Map 3.2
• 09421904268319: Volpara Density Map 4.0
• 09421904268289: Volpara Density Map 3.4.2