Table 1. AI Medical Device Programs Currently Approved by the PMDA for X-ray, CT, MRI, and Ultrasound.

From: The Future of Breast Cancer Diagnosis in Japan with AI and Ultrasonography

Approval Date Product Name Company Modality Description
2019.09 Medical Image Analysis Software EIRL aneurysm LPixel MRI Detects candidate points similar to arterial aneurysmal deformation.
2019.12 Similar Image Case Search Software FS-CM687 Fujifilm CT Analyzes target areas (lung nodules, diffuse diseases, liver tumors) and supports the search for similar images.
2020.05 Lung Nodule Detection Program FS-AI688 Fujifilm CT Detects candidates with lung nodule-like shadows.
2020.06 COVID-19 Pneumonia Image Analysis AI Program InferRead CT Pneumonia CES Descartes CT Indicates the possibility of COVID-19 pneumonia based on image findings and marks related areas.
2020.06 AI-Rad Companion Siemens Healthcare CT Provides functions such as lung nodule detection and measurement/display of lung parenchyma.
2020.06 COVID-19 Pneumonia Image Analysis Program Ali-M3 MIC Medical CT Indicates possible COVID-19 pneumonia based on image findings and marks related areas.
2020.08 Medical Image Analysis Software EIRL X-Ray Long Nodule LPixel X-ray Detects candidate areas suspected of having lung nodules.
2020.11 Breast Cancer Diagnosis Support Program RN-CES Descartes CES Descartes Ultrasound Detects lesion candidate areas.
2021.05 COVID-19 Pneumonia Image Analysis Program FS-AI693 Fujifilm CT Indicates possible COVID-19 pneumonia based on image findings and marks related areas.
2021.07 Chest X-ray Lesion Detection (CAD) Program LU-AI689 Fujifilm X-ray Detects candidate areas of lung nodules, tumor shadows, infiltrative shadows, and pneumothorax.
2021.09 Rib Fracture Detection Program FS-AI691 Fujifilm CT Marks rib fracture or suspected fracture areas.
2021.10 Image Diagnosis Support Software KDSS-XR-AI-101 Konica Minolta X-ray Supports detection of nodular shadows and infiltrative shadows.
2021.12 Chest X-ray Pneumonia Detection Engine DoctorNet JLK-CRP DoctorNet X-ray Displays possible imaging findings seen in infectious pneumonia.
2021.12 HOPE LifeMark-CAD Pneumonia Image Analysis Support Program for COVID-19 Fujitsu Japan CT Indicates possible COVID-19 pneumonia based on image findings and marks related areas.
2022.06 COVID-19 Pneumonia Analysis Software SCO-PA01 Canon Medical Systems CT Indicates possible COVID-19 pneumonia based on image findings and marks related areas.
2022.12 Medical Image Analysis Software EIRL Chest XR LPixel X-ray Detects candidate areas suspected of having abnormal shadows (nodules, consolidations, atelectasis, interstitial shadows).
2023.11 Fibrosis-Associated Interstitial Lung Disease Detection Support Program BMAX Cosmotec X-ray Detects findings associated with fibrosis in interstitial lung disease and present their confidence scores.
2024.05 Smart Opinion METIS Eye Smart Opinion Ultrasound Detects candidate areas of suspected lesions and determines whether detailed examination is necessary.
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