Saige-Density SDN1000

GUDID 00860005144020

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

Device Issuing Agency	Device ID
GS1	00860005144020 [Primary]

QIH	Automated Radiological Image Processing Software

Steralize Prior To Use	false
Device Is Sterile	false

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

Mark Image Registration \| Serial	Company Trademark Application Date
SAIGE-DENSITY 97348076 not registered Live/Pending	DeepHealth 2022-04-05