Samsung Medison Co., Ltd.
13 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| January 5, 2026 | 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 | Radiology | IYN |
| July 18, 2025 | 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 | Radiology | IYN |
| February 12, 2025 | 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 | Radiology | IYN |
| December 10, 2024 | 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 | Radiology | IYN |
| November 27, 2024 | K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Radiology | IYN |
| October 11, 2024 | K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Radiology | IYN |
| June 21, 2024 | K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Radiology | IYN |
| June 12, 2024 | K240516 | RS85 Diagnostic Ultrasound System | Radiology | IYN |
| October 3, 2023 | K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Radiology | IYN |
| February 13, 2023 | K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Radiology | IYN |
| August 22, 2022 | K221599 | HS40 Diagnostic Ultrasound System | Radiology | IYN |
| June 29, 2022 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Radiology | IYN |
| September 9, 2021 | K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Radiology | IYN |