Saige-Q

GUDID 00860005144006

Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM) screening mammograms using artificial intelligence to act as a prioritization tool for interpreting radiologists. By automatically indicating whether a given mammogram is suspicious for malignancy, Saige-Q can help the user prioritize or triage cases in their worklist (or queue) that may benefit from prioritized review. Saige-Q takes as input a set of x-ray mammogram DICOM files from a single screening mammography study (FFDM or DBT). The software first checks that the study is appropriate for Saige-Q analysis and then extracts, processes and analyses the DICOM images using an artificial intelligence algorithm. As a result of the analysis, the software generates a Saige-Q code indicating the software’s suspicion of the presence of findings suggestive of breast cancer. For mammograms given a Saige-Q code of “Suspicious,” the software also generates a compressed preview image, which is for informational purposes only and is not intended for diagnostic use. The Saige-Q code can be viewed by radiologists on a picture archiving and communication system (PACS), Electronic Patient Record (EPR), and/or Radiology Information System (RIS) worklist and can be used to reorder the worklist. As a software-only device, Saige-Q can be hosted on a compatible host server connected to the necessary clinical IT systems such that DICOM studies can be received and the resulting outputs returned where they can be incorporated into the radiology worklist. The Saige-Q codes can be used for triage or prioritization. For example, “Suspicious” studies could be given prioritized review. With a worklist that supports sorting, batches of mammograms could also be sorted based on the Saige-Q code.

Deephealth, Inc.

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Primary Device ID00860005144006
NIH Device Record Keyf5fd9463-7d36-424a-a680-32862cd72103
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaige-Q
Version Model Number2.0.0
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
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
GS100860005144006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-06
Device Publish Date2021-04-28

Devices Manufactured by Deephealth, Inc.

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-Q2021-05-06Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM) screening mammograms using artificial intelligence to act as a prioritization tool for interpreting radiologists. By automatically indicating whether a given mammogram is suspicious for malignancy, Saige-Q can help the user prioritize or triage cases in their worklist (or queue) that may benefit from prioritized review. Saige-Q takes as input a set of x-ray mammogram DICOM files from a single screening mammography study (FFDM or DBT). The software first checks that the study is appropriate for Saige-Q analysis and then extracts, processes and analyses the DICOM images using an artificial intelligence algorithm. As a result of the analysis, the software generates a Saige-Q code indicating the software’s suspicion of the presence of findings suggestive of breast cancer. For mammograms given a Saige-Q code of “Suspicious,” the software also generates a compressed preview image, which is for informational purposes only and is not intended for diagnostic use. The Saige-Q code can be viewed by radiologists on a picture archiving and communication system (PACS), Electronic Patient Record (EPR), and/or Radiology Information System (RIS) worklist and can be used to reorder the worklist. As a software-only device, Saige-Q can be hosted on a compatible host server connected to the necessary clinical IT systems such that DICOM studies can be received and the resulting outputs returned where they can be incorporated into the radiology worklist. The Saige-Q codes can be used for triage or prioritization. For example, “Suspicious” studies could be given prioritized review. With a worklist that supports sorting, batches of mammograms could also be sorted based on the Saige-Q code.
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-Q]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAIGE-Q
SAIGE-Q
90258964 not registered Live/Pending
Deephealth
2020-10-16
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