Table 6.
AI-enabled hardware radiology devices cleared by FDA August 2021 to July 2024.
| Type of device | Number | product code |
|---|---|---|
| Ultrasonic pulsed Doppler imaging system | 28 | IYN |
| Ultrasonic pulsed echo imaging system | 1 | IYO |
| Mobile X-ray system | 1 | IZL |
| Computed tomography X-ray system | 38 | JAK |
| Emission computed tomography | 8 | KPS |
| Magnet resonance diagnostic device | 26 | LNH |
| Stationary X-ray system | 3 | MQB |
| Densitometer, bone | 1 | KGI |
| Image-intensified fluoroscopic X-ray system | 2 | OWB |
| Optoacoustic imaging system | 1 | QNK |
| Medical charged-particle radiation therapy system | 15 | MUJ |