| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00811852030134 | 1.9 | Viz LVO 1.9 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 2 | 00811852030141 | 1.4 | Viz CTP 1.4 | LLZ | System, image processing, radiological | 2 | Viz CTP | |
| 3 | 00811852030066 | 1.2 | Viz CTP 1.2 | LLZ | System, image processing, radiological | 2 | Viz CTP | |
| 4 | 00811852030011 | 1.1 | Viz CTP 1.1 | LLZ | System, image processing, radiological | 2 | Viz CTP | |
| 5 | 00811852030288 | Viz CTP Software | Viz CTP v1.9 (2022-09-04) | LLZ | System, Image Processing, Radiological | 2 | Viz CTP | |
| 6 | 00811852030103 | 1.3 | Viz CTP 1.3 | LLZ | System, image processing, radiological | 2 | Viz CTP | |
| 7 | 00811852030165 | 1.3 | Viz ICH 1.3 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz ICH | |
| 8 | 00811852030318 | Viz ICH Software | Viz ICH v1.6 (2022-07-25) | QAS | Radiological Computer-Assisted Triage And Notification Software | 2 | Viz ICH | |
| 9 | 00811852030097 | 1.7 | Viz LVO 1.7 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 10 | 00811852030080 | 1.6 | Viz LVO 1.6 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 11 | 00811852030073 | 1.5 | Viz LVO 1.5 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 12 | 00811852030059 | 1.4 | Viz LVO 1.4 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 13 | 00811852030042 | 1.3 | Viz LVO 1.3 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 14 | 00811852030035 | 1.2 | Viz LVO 1.2 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 15 | 00811852030004 | 1.1 | Viz LVO v1.1 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 16 | 00811852030189 | 1.11 | Viz LVO 1.11 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 17 | 00811852030172 | 1.10 | Viz LVO 1.10 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO | |
| 18 | 00811852030301 | Viz LVO Software | Viz LVO v1.14 (2021-06-15) | QAS | Radiological Computer-Assisted Triage And Notification Software | 2 | Viz LVO | |
| 19 | 00811852030110 | 1.8 | Viz LVO 1.8 | QAS | Radiological computer-assisted triage and notification software | 2 | Viz LVO |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00860005144006 | 2.2.0 | Saige-Q is a software workflow device that processes Digital Breast Tomosynthesi 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. | Saige-Q | DEEPHEALTH, INC. | |
| 2 | 00840682147231 | PACS 1.0 | Designated Medical Device, Critical Care Suite PACS 1.0 | Critical Care Suite | GE MEDICAL SYSTEMS, INC. | |
| 3 | 00840682146340 | 1.0 | Critical Care Suite | GE MEDICAL SYSTEMS, INC. | ||
| 4 | 00811852030196 | Viz ANEURYSM Software | Viz ANEURYSM v1.5 (2022-08-29) | Viz ANEURYSM | VIZ.AI, INC. | |
| 5 | 00195278217981 | 2.0 | Critical Care Suite 2.0, Designated Medical Device | Critical Care Suite | GE MEDICAL SYSTEMS, INC. | |
| 6 | M722XD22145P212210 | 1.1.1 | ClearRead Xray Pneumothorax on Docker Platform | ClearRead Xray Pneumothorax | RIVERAIN TECHNOLOGIES, INC. | |
| 7 | M722XC22145P212210 | 1.1.1 | ClearRead Xray Pneumothorax on Console Platform | ClearRead Xray Pneumothorax | RIVERAIN TECHNOLOGIES, INC. | |
| 8 | M722X22145P212210 | 1.1.1 | ClearRead Xray Pneumothorax on Xray Platform | ClearRead Xray Pneumothorax | RIVERAIN TECHNOLOGIES, INC. | |
| 9 | 08800076000124 | 1.0 | Lunit INSIGHT CXR Triage | LUNIT INC. | ||
| 10 | 07290018016107 | 1.0 | HealthPPT | NANO-X AI LTD | ||
| 11 | 07290018016084 | 1.0 | HealthVCF | NANO-X AI LTD | ||
| 12 | 07290018016077 | 2.0.0 | HealthPNX | NANO-X AI LTD | ||
| 13 | 07290018016060 | 2.2 | HealthMammo | NANO-X AI LTD | ||
| 14 | 07290018016046 | 1.0.0 | HealthCXR | NANO-X AI LTD | ||
| 15 | 07290018016015 | 1.0.6 | HealthPNX | NANO-X AI LTD |