DM-Density

GUDID 10627843712753

Densitas Incorporated

Radiology DICOM image processing application software

• Primary Device ID: 10627843712753
• NIH Device Record Key: 1420fb2e-a89b-4cca-82bb-e42b9f185ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DM-Density
• Version Model Number: 2.1.0b
• 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	10627843712753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170540

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: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-03-16

Devices Manufactured by Densitas Incorporated

• 00628678950047 - intelliMammo® densityAI™: 2024-09-16 Vesion 2.8.6
• 00628678950030 - intelliMammo® densityAI™: 2023-11-07 Version 2.8.4
• 00628678950023 - intelliMammo™ densityAI™: 2022-12-07 Version 2.8.0
• 00628678950016 - densitas® densityAI™: 2022-05-11 Version 2.7.0
• 10627843712777 - densitas® densityai™: 2020-09-02 densitas® densityai™ 2.6.2
• 10627843712753 - DM-Density: 2019-10-07
• 10627843712753 - DM-Density: 2019-10-07
• 10627843712760 - densitasdensity: 2019-10-07 densitasdensity 2.4.1