Table 7.
AI-enabled software radiology devices cleared by FDA August 2021 to July 2024.
| Type of device | Number | Product code | AI specific | Definition summary |
|---|---|---|---|---|
| System, image processing, radiological | 56 | LLZ | N | Image visualization, enhancement, and segmentation |
| Lung CT computer-aided detection | 2 | OEB | N | To assist radiologists in the review of multi-slice CT of the chest and highlight potential nodules that the radiologist should review |
| Liver iron concentration imaging companion diagnostic for deferasirox | 1 | PCS | N | The determination of iron in the liver for any indication where an assessment of liver iron concentration is needed |
| Medical image analyser | 9 | MYN | N | Now mainly reclassified to Class II |
| Computer-assisted diagnostic software for lesions suspicious for cancer | 5 | POK | N | Assist users in characterizing lesions identified on acquired medical images |
| Radiological computer-assisted triage and notification software | 26 | QAS | Y | Aid in prioritization and triage of time-sensitive patient detection and diagnosis based on the analysis of medical images |
| Radiological computer-assisted prioritization software for lesions | 19 | QFM | Y | To aid in prioritization and triage of time-sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems |
| Radiological computer-assisted detection/diagnosis software for lesions suspicious for cancer | 10 | QDQ | Y | To aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (eg, mammography, MR, CT, ultrasound, radiography) |
| Automated radiological image processing software | 68 | QIH | (Y) | Automated radiological image processing and analysis tools. Software implementing artificial intelligence including non-adaptive machine learning algorithms trained with clinical and/or artificial data |
| Radiological image processing software for radiation therapy | 23 | QKB | Y | Semi-automatic or fully automated radiological image processing and analysis tools for radiation therapy |
| Radiological computer-assisted detection/diagnosis software for fracture | 4 | QBS | Y | Aid in the detection, localization, and/or characterization of fracture on acquired medical images (eg, radiography, MR, CT) |
| Image acquisition and/or optimization guided by artificial intelligence | 2 | QJU | Y | Aid in the acquisition and/or optimization of images and/or diagnostic signals |
| Radiological machine learning-based quantitative imaging software with change control plan | 1 | QVD | Y | Software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs |