Table 1.
Overview of FDA-approved AI-based radiological software systems in clinical oncology
| Device | Company | Short description | FDA approval number | Date of approval* |
|---|---|---|---|---|
| Breast cancer | ||||
| BU-CAD | TaiHao Medical Inc. | Detection of suspicious lesions for breast cancer | K210670 | 2021 |
| Koios DS | Koios Medical, Inc. | Detection of suspicious lesions for breast and thyroid cancer | K212616 | 2021 |
| MammoScreen 2.0 | Therapixel | Detection of suspicious lesions for breast cancer | K211541 | 2021 |
| Lunit INSIGHT MMG | Lunit Inc. | Detection of suspicious lesions for breast cancer | K211678 | 2021 |
| Saige-Q | DeepHealth, Inc. | Detection of suspicious lesions for breast cancer | K203517 | 2021 |
| Visage Breast Density | Visage Imaging GmbH | The BI-RADS breast density classification | K201411 | 2021 |
| Imagio Breast Imaging System | Seno Medical Instruments, Inc. | The BI-RADS breast density classification | P200003 | 2021 |
| PowerLook Density Assessment Software V4.0 | ICAD Inc. | The BI-RADS breast density classification | K211506 | 2021 |
| Volpara Imaging Software | Volpara Health Technologies Limited | The BI-RADS breast density classification | K211279 | 2021 |
| Genius AI Detection | Hologic, Inc. | Identification of suspicious breast lesions | K201019 | 2020 |
| Genius AI Detection | Hologic, Inc. | Detection of suspicious lesions for breast cancer | K201019 | 2020 |
| WRDensity by Whiterabbit.ai | Whiterabbit.ai Inc. | Software for BI-RADS breast density classification | K202013 | 2020 |
| MammoScreen | Therapixel | Radiological software for lesions suspicious for breast cancer | K192854 | 2020 |
| HealthMammo | Zebra Medical Vision Ltd. | Identification of suspicious breast lesions | K200905 | 2020 |
| Densitas Densityai | Densitas, Inc. | The BI-RADS breast density category using mammography | K192973 | 2020 |
| TransparaTM | Screenpoint Medical B.V. | Identification of suspicious breast lesions | K192287 | 2019 |
| ProFound AI Software V2.1 | ICAD Inc. | Identification of suspicious breast lesions | K191994 | 2019 |
| cmTriage | CureMetrix, Inc. | Identification of suspicious breast lesions | K183285 | 2019 |
| TransparaTM | Screenpoint Medical B.V. | Identification of suspicious breast lesions | K192287 | 2019 |
| Koios DS for Breast | Koios Medical, Inc | Identification of suspicious breast lesions | K190442 | 2019 |
| PowerLook Tomo Detection V2 Software | ICAD Inc. | Identification of suspicious breast lesions | K182373 | 2018 |
| ProFound™ AI Software V2.1 | iCAD, Inc | The BI-RADS breast density classification using mammography | K191994 | 2018 |
| DM-Density | Densitas, Inc. | The BI-RADS breast density classification | K170540 | 2018 |
| Volpara Imaging Software | Volpara Health Technologies Limited | The BI-RADS breast density classification | K182310 | 2018 |
| DenSeeMammo | STATLIFE | The BI-RADS breast density classification | K173574 | 2018 |
| Prostate cancer | ||||
| ProstatID | ScanMed, LLC | The detection and diagnosis of prostate cancer utilizing MRI images | K212783 | 2022 |
| aPROMISE | EXINI Diagnostics AB | Identification and quantitative analysis of suspicious regions on PSMA PET/CT | K211655 | 2021 |
| QUIBIM Precision Prostate (qp-Prostate) | QUIBIM S.L. | Software to detect prostate cancer and prostate diseases | K203582 | 2021 |
| PROView | GE Medical Systems SCS | The PI-RADS prostate density classification using mpMRI | K193306 | 2020 |
| A View LCS | Coreline Soft Co., Ltd. | The PI-RADS prostate density classification using mpMRI | K201710 | 2020 |
| Quantib Prostate | Quantib BV | The PI-RADS prostate density classification using mpMRI | K202501 | 2020 |
| ClearRead CT | Riverain Technologies, LLC | The PI-RADS prostate density classification using mpMRI | K161201 | 2016 |
| Lung cancer | ||||
| syngo.CT Lung CAD (Version VD20) | Siemens Healthcare GmbH | Image processing of CT scans for solid-subsolid nodules | K203258 | 2021 |
| Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform | Optellum Ltd | Identify of suspected pulmonary nodules | K202300 | 2021 |
| Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | Detection of suspected pulmonary nodules | K201560 | 2021 |
| InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | Identify of suspected pulmonary nodules | K192880 | 2020 |
| AVIEW LCS | Coreline Soft Co., Ltd | Identify of suspected pulmonary nodules | K193220 | 2020 |
| Syngo.CT Lung CAD | Siemens Medical Solutions, Inc | Identify of suspected pulmonary nodules | K193216 | 2020 |
| Arterys MICA | Arterys Inc | Diagnostic imaging for liver, lung cancer | K182034 | 2018 |
| Brain | ||||
| NeuroQuant | CorTechs Labs, Inc | Interpretation of MRI brain images | K170981 | 2017 |
| Quantib Brain 1.2 | Quantib BV | Interpretation of MRI brain images | K163013 | 2017 |
| CT CoPilot | ZepMed | Identification and segmentation of brain structures | K161322 | 2016 |
| cNeuro cMRI | Combinostics Oy | Identification and segmentation of brain structures | K171328 | 2018 |
| Miscellaneous | ||||
| aPROMISE X | EXINI Diagnostics AB | Image processing, quantification and reporting of PET scans | K220590 | 2022 |
| Koios DS | Koios Medical, Inc. | Detection of suspicious lesions for breast and thyroid cancer | K212616 | 2021 |
| Saige-Dx | DeepHealth, Inc. | Radiological software for lesions suspicious for cancer | K220105 | 2022 |
| Discovery MI Gen2 | GE Medical Systems, LLC. | PET/CT system for producing attenuation corrected images | K211846 | 2021 |
| Ezra Plexo Software | Ezra AI Inc. | Software for detecting cancerous lesions in MR images | K192969 | 2020 |
| QuantX | Quantitative Insights, Inc. | Radiological software for lesions suspicious for cancer | DEN170022 | 2020 |
| Deep Learning Image Reconstruction | GE Medical Systems, LLC. | CT image reconstruction | K183202 | 2019 |
| SubtlePET | Subtle Medical, Inc. | Noise reduction algorithm | K182336 | 2018 |
| Quantitative Total Extensible Imaging (QTxi) | AIQ Solutions, Inc. | Create ROI contours for quantitative/statistical analysis and dosimetry | K173444 | 2018 |
| Arterys Oncology Dl | Arterys Inc. | Asist with analysis of a suspicious lesion on CT or MRI | K173542 | 2018 |
| Radiomics App V1.0 | Microsoft Corp. | Analysis of CT and MRI for dosimetry purposes | K173420 | 2017 |
| PixelShine | AlgoMedica | CT noise reduction algorithm | K161625 | 2016 |
* Last FDA update on approved AI-enabled medical technologies was released on October 5, 2022.
AI: artificial intelligence; CT: computed tomography; FDA: Food and Drug Administration; MRI: magnetic resonance imaging; mpMRI: multi-parametric MRI; ROI: region of interest.