VolparaDensity

GUDID 09421904268029

VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)

VOLPARA HEALTH TECHNOLOGIES LIMITED

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 09421904268029
• NIH Device Record Key: 4b8e38a8-3013-4db1-8daa-3129ea79d7ab
• Commercial Distribution Discontinuation: 2017-08-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VolparaDensity
• Version Model Number: 3.2
• 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	09421904268029 [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: 2016-04-22

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