densitas® densityai™

GUDID 10627843712777

densitas® densityai™ 2.6.2

Densitas Incorporated

Radiology DICOM image processing application software

• Primary Device ID: 10627843712777
• NIH Device Record Key: 2c155d1e-9782-41be-a53d-cb7ef64de06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: densitas® 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	10627843712777 [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: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [densitas® densityai™]

• 10627843712777: densitas® densityai™ 2.6.2
• 00628678950016: Version 2.7.0