| Z-1177-2026 | Class II | Alphenix INFX-8000F, interventional fluoroscopic x-ray system | December 19, 2025 |
| Z-1017-2026 | Class II | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | December 19, 2025 |
| Z-1018-2026 | Class II | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | December 19, 2025 |
| Z-1178-2026 | Class II | Alphenix INFX-8000H, interventional fluoroscopic x-ray system | December 19, 2025 |
| Z-1176-2026 | Class II | Alphenix INFX-8000C, interventional fluoroscopic x-ray system | December 19, 2025 |
| Z-1179-2026 | Class II | Alphenix INFX-8000V, interventional fluoroscopic x-ray system | December 19, 2025 |
| Z-0327-2026 | Class II | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. | October 16, 2025 |
| Z-0037-2026 | Class II | This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional ang | September 2, 2025 |
| Z-0284-2025 | Class II | Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging syst | September 17, 2024 |
| Z-2041-2024 | Class II | MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MR | May 10, 2024 |
| Z-1248-2024 | Class II | MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 | January 29, 2024 |
| Z-1249-2024 | Class II | MRI system: Vantage Elan, Model: MRT-2020 | January 29, 2024 |
| Z-1250-2024 | Class II | Vantage Titan, Model: MRT-1504 | January 29, 2024 |
| Z-1155-2024 | Class II | The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose | November 15, 2023 |
| Z-1154-2024 | Class II | The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used i | November 15, 2023 |
| Z-2392-2023 | Class II | INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE | June 22, 2023 |
| Z-0198-2023 | Class II | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI7 | September 29, 2022 |
| Z-1289-2022 | Class II | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, | May 3, 2022 |
| Z-1666-2022 | Class II | INFX-8000V. For radiographic and fluoroscopic studies and intervention. | January 31, 2022 |
| Z-0492-2022 | Class II | Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000 | December 20, 2021 |