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.
Radiology DICOM image processing application software| Primary Device ID | 00860005144013 |
| NIH Device Record Key | 186f6fc7-e073-454b-a041-d07b32266443 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Saige-Dx |
| Version Model Number | 2.0.1 |
| Catalog Number | SDX1000 |
| 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 |
Customer Support Contacts
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health | |
| Phone | 424-832-1480 |
| info@deep.health |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005144013 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220105
FDA Product Code
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-03 |
| Device Publish Date | 2022-05-26 |
Devices Manufactured by Deephealth, Inc.
| 00860005144020 - Saige-Density | 2023-04-05 |
| 00860005144013 - Saige-Dx | 2022-06-03Saige-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-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 |
Trademark Results [Saige-Dx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAIGE-DX 90258955 not registered Live/Pending |
Deephealth 2020-10-16 |
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