Saige-Density SDN1000

GUDID 00860005144020

Deephealth, Inc.

Radiology DICOM image processing application software

• Primary Device ID: 00860005144020
• NIH Device Record Key: e7216a5a-3c62-4a6d-8bd1-a1496dd0df21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saige-Density
• Version Model Number: 2.1.0
• Catalog Number: SDN1000
• Company DUNS: 081336616
• Company Name: Deephealth, Inc.
• 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

Customer Support Contacts

• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health
• Phone: 424-832-1480
• Email: info@deep.health

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005144020 [Primary]

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2023-04-05
• Device Publish Date: 2023-03-28

Devices Manufactured by Deephealth, Inc.

• 00860005144020 - Saige-Density: 2023-04-05
• 00860005144020 - Saige-Density: 2023-04-05
• 00860005144013 - Saige-Dx: 2022-06-03 Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists
• 00860005144006 - Saige-Q: 2021-05-06 Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM