| 2026-01-05 | K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2025-07-18 | K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2025-02-12 | K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2024-12-10 | K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2024-11-27 | K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2024-10-11 | K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2024-06-21 | K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2024-06-12 | K240516 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2023-12-21 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology |
| 2023-10-03 | K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2023-04-21 | K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology |
| 2023-02-13 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2022-08-22 | K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2022-06-29 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2022-04-05 | K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., LTD | Radiology |
| 2021-09-09 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | Radiology |
| 2021-09-08 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology |
| 2021-05-13 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison CO., LTD. | Radiology |