Saige-Dx SDX1000

GUDID 00860005144013

Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists. By automatically detecting the presence or absence of soft tissue lesions and calcifications in mammography images, Saige-Dx can help improve reader performance, while also reducing reading time. The software takes as input a set of x-ray mammogram DICOM files from a single digital breast tomosynthesis (DBT) study and generates finding-level outputs for each image analyzed, as well as an aggregate case- level assessment. Saige-Dx processes both the DBT image stacks and the associated 2D images (full-field digital mammography (FFDM) and/or synthetic 2D images) in a DBT study. For each image, Saige-Dx outputs bounding boxes circumscribing any detected findings and assigns a Finding Suspicion Level to each finding, indicating the degree of suspicion that the finding is malignant. Saige-Dx uses the results of the finding-level analysis to generate a Case Suspicion Level, indicating the degree of suspicion for malignancy across the case. Saige-Dx encapsulates the finding and case-level results into a DICOM Structured Report (SR) object containing markings that can be overlaid on the original mammogram images using a viewing workstation and a DICOM Secondary Capture (SC) object containing a summary report of the Saige-Dx results.

Deephealth, Inc.

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Primary Device ID00860005144013
NIH Device Record Key186f6fc7-e073-454b-a041-d07b32266443
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaige-Dx
Version Model Number2.0.1
Catalog NumberSDX1000
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
Phone424-832-1480
Emailinfo@deep.health
Phone424-832-1480
Emailinfo@deep.health

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005144013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-03
Device Publish Date2022-05-26

Devices Manufactured by Deephealth, Inc.

00860005144020 - Saige-Density2023-04-05
00860005144013 - Saige-Dx2022-06-03Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists. By automatically detecting the presence or absence of soft tissue lesions and calcifications in mammography images, Saige-Dx can help improve reader performance, while also reducing reading time. The software takes as input a set of x-ray mammogram DICOM files from a single digital breast tomosynthesis (DBT) study and generates finding-level outputs for each image analyzed, as well as an aggregate case- level assessment. Saige-Dx processes both the DBT image stacks and the associated 2D images (full-field digital mammography (FFDM) and/or synthetic 2D images) in a DBT study. For each image, Saige-Dx outputs bounding boxes circumscribing any detected findings and assigns a Finding Suspicion Level to each finding, indicating the degree of suspicion that the finding is malignant. Saige-Dx uses the results of the finding-level analysis to generate a Case Suspicion Level, indicating the degree of suspicion for malignancy across the case. Saige-Dx encapsulates the finding and case-level results into a DICOM Structured Report (SR) object containing markings that can be overlaid on the original mammogram images using a viewing workstation and a DICOM Secondary Capture (SC) object containing a summary report of the Saige-Dx results.
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-Dx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAIGE-DX
SAIGE-DX
90258955 not registered Live/Pending
Deephealth
2020-10-16
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