intelliMammo® densityAI™

GUDID 00628678950030

Version 2.8.4

Densitas Incorporated

Radiology DICOM image processing application software

• Primary Device ID: 00628678950030
• NIH Device Record Key: 56801023-f991-4b85-8275-55117b1d978d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: intelliMammo® densityAI™
• Version Model Number: 2.x.y
• Company DUNS: 204371579
• Company Name: Densitas Incorporated
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628678950030 [Primary]

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: 2023-11-07
• Device Publish Date: 2023-10-30

On-Brand Devices [intelliMammo® densityAI™]

• 00628678950030: Version 2.8.4
• 00628678950047: Vesion 2.8.6