Saige-Density SDN1000

GUDID 00860005144020

Deephealth, Inc.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00860005144020
NIH Device Record Keye7216a5a-3c62-4a6d-8bd1-a1496dd0df21
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaige-Density
Version Model Number2.1.0
Catalog NumberSDN1000
Company DUNS081336616
Company NameDeephealth, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005144020 [Primary]

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-05
Device Publish Date2023-03-28

Devices Manufactured by Deephealth, Inc.

00860005144020 - Saige-Density2023-04-05
00860005144020 - Saige-Density2023-04-05
00860005144013 - Saige-Dx2022-06-03 Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists
00860005144006 - Saige-Q2021-05-06 Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM

Trademark Results [Saige-Density]

Mark Image

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