VolparaDensity

GUDID 09421904268098

VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)

VOLPARA HEALTH TECHNOLOGIES LIMITED

Radiology DICOM image processing application software

• Primary Device ID: 09421904268098
• NIH Device Record Key: 1bbac5da-2e0d-43a6-a6c2-fd17c58e1bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VolparaDensity
• Version Model Number: 3.3
• 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	09421904268098 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-08-16

On-Brand Devices [VolparaDensity]

• 09421904268029: VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)
• 09421904268166: VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1)
• 09421904268098: VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
• 09421904268258: 3.4.2
• 09421904268241: 4.0