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Found 7 results
510(k) Data Aggregation
K Number
K243703Device Name
TechLive
Manufacturer
DeepHealth, Inc.
Date Cleared
2025-06-05
(188 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use.
Device Description
TechLive is a software application intended to provide remote access for real-time image acquisition, assistance, review, monitoring and standardization of imaging devices across multiple locations. It is a vendor neutral solution allowing read-only or full access control to connected devices. TechLive is also intended for training of medical personnel working on medical imaging devices. TechLive is not intended for diagnostic use.
Clinical users can remotely access imaging devices from a computer via a secure software connection that streams video and audio, including access to keyboard and mouse controls. This setup allows remote users to assist local in-suite assistants or other clinical users by means of audio/video connection or perform remote acquisitions themselves. Depending upon the device used to acquire the images, the remote access can allow for "view mode", to support the in-suite assistant, or "control mode", where the remote user controls the console software of the imaging device. Remote access to the local imaging device can only be granted by the local in-suite assistant and can be granted or revoked as needed using an on-premises computer installed with the assistance touch interface. "Control mode" access may be granted on-demand or prior to acquisition to access the scanner. TechLive offers a secure collaboration platform with live audio and video, enabling remote acquisition and seamless collaboration among healthcare professionals.
TechLive is vendor-neutral and compatible with existing imaging devices, including Ultrasound (US), Magnetic Resonance Imaging (MRI), Computer Tomography (CT), and Positron Emission Tomography (PET/CT).
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K Number
K243688Device Name
Saige-Dx (3.1.0)
Manufacturer
DeepHealth, Inc.
Date Cleared
2024-12-19
(20 days)
Product Code
QDQ
Regulation Number
892.2090Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence or absence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.
Device Description
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 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.
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K Number
K243705Device Name
Saige-Density (2.5.0)
Manufacturer
DeepHealth, Inc
Date Cleared
2024-12-19
(20 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. Saige-Density provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Saige-Density produces adjunctive information. It is not a diagnostic aid.
Device Description
Saige-Density is Software as a Medical Device that processes screening and diagnostic digital mammograms using deep learning techniques and generates outputs that serve as an aid for interpreting radiologists in assessing breast density. The software takes as input a single x-ray mammogram study and processes all acceptable 2D image DICOM files (FFDM and/or 2D synthetics) and generates a single study-level breast density category. Two DICOM files are outputted as a result: 1) a structured report (SR) DICOM object containing the case-level breast density category and 2) a secondary capture (SC) DICOM object containing a summary report with the study-level density category. Both output files contain the same breast density category ranging from "A" through "D" following Breast Imaging Reporting and System (BI-RADS) 5th Edition reporting guidelines. The SC report and/or the SR file may be viewed on a mammography viewing workstation.
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K Number
K241747Device Name
Saige-Dx
Manufacturer
DeepHealth, Inc
Date Cleared
2024-11-18
(153 days)
Product Code
QDQ
Regulation Number
892.2090Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence or absence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.
Device Description
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 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.
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K Number
K222275Device Name
Saige-Density
Manufacturer
DeepHealth, Inc.
Date Cleared
2022-12-16
(140 days)
Product Code
QIH, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. Saige-Density provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Saige-Density produces adjunctive information. It is not a diagnostic aid.
Device Description
Saige-Density is Software as a Medical Device that processes screening and diagnostic digital mammograms using deep learning techniques and generates outputs that serve as an aid for interpreting radiologists in assessing breast density. The software takes as input a single x-ray mammogram study and processes all acceptable 2D image DICOM files (FFDM and/or 2D synthetics) and generates a single study-level breast density category. Two DICOM files are outputted as a result: 1) a structured report (SR) DICOM object containing the case-level breast density category and 2) a secondary capture (SC) DICOM object containing a summary report with the study-level density category. Both output files contain the same breast density category ranging from "A" through "D" following Breast Imaging Reporting and Data System (BI-RADS) 5th Edition reporting guidelines. The SC report and/or the SR file may be viewed on a mammography viewing workstation.
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K Number
K220105Device Name
Saige-Dx
Manufacturer
DeepHealth, Inc.
Date Cleared
2022-05-12
(120 days)
Product Code
QDQ
Regulation Number
892.2090Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.
Device Description
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 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 caselevel 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.
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K Number
K203517Device Name
Saige-Q
Manufacturer
DeepHealth, Inc.
Date Cleared
2021-04-16
(137 days)
Product Code
QFM
Regulation Number
892.2080Why did this record match?
Applicant Name (Manufacturer) :
DeepHealth, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. Saige-Q uses an artificial intelligence algorithm to generate a code for a given mammogram, indicative of the software's suspicion that the mammogram contains at least one suspicious finding. Saige-Q makes the assigned codes available to a PACS/EPR/RIS/workstation for worklist prioritization or triage.
Saige-Q is intended for passive notification only and does not provide any diagnostic information beyond triage and prioritization. Thus, it is not intended to replace the review of images or be used on a stand-alone basis for clinical decision-making. The decision to use Saige-Q codes and how to use those codes is ultimately up to the interpreting radiologist. The interpreting radiologist is reviewing each exam on a diagnostic viewer and evaluating each patient according to the current standard of care.
Device Description
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.
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