Samsung Medison vs Siemens Medical Solutions USA: FDA-cleared AI devices
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 49 devices. They overlap on Radiology (18 vs 67). The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Samsung Medison Co., Ltd. is 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 on January 5, 2026.
| Samsung Medison | Siemens Medical Solutions USA | |
|---|---|---|
| AI devices | 18 | 67 |
| Share of the FDA AI list | 1.1% | 4.2% |
| First decision | May 13, 2021 | January 24, 2014 |
| Latest decision | January 5, 2026 | June 25, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (18) | Radiology (67) |
| Top product code | IYN (18) | LNH (17) |
| 510(k) | 18 | 66 |
| De Novo | 0 | 0 |
| PMA | 0 | 1 |
| Dated 2026 | 1 | 5 |
Year by year
| Year | Samsung Medison | Siemens Medical Solutions USA |
|---|---|---|
| 2026 | 1 | 5 |
| 2025 | 2 | 4 |
| 2024 | 5 | 12 |
| 2023 | 4 | 10 |
| 2022 | 3 | 15 |
| 2021 | 3 | 5 |
| 2020 | 0 | 9 |
| 2019 | 0 | 5 |
| 2017 | 0 | 1 |
| 2014 | 0 | 1 |
Where they overlap
Shared product codes
Latest from Samsung Medison
- 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 SystemSamsung Medison Co., Ltd. · Radiology
- 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 SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- 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 SystemSamsung Medison Co., Ltd. · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
Latest from Siemens Medical Solutions USA
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Samsung Medison or Siemens Medical Solutions USA?
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 49 devices.
Do Samsung Medison and Siemens Medical Solutions USA have AI devices in the same specialty?
They overlap on Radiology (18 vs 67).
Which company has the more recent AI clearance?
The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Samsung Medison Co., Ltd. is 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 on January 5, 2026.
How many AI devices did each company clear in 2026?
Samsung Medison has 1 devices dated 2026, and Siemens Medical Solutions USA has 5.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (18 vs 5).
Cite as: AI Device Radar, “Samsung Medison vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/samsung-medison-co-ltd/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).