Philips Ultrasound vs Samsung Medison: FDA-cleared AI devices
Philips Ultrasound, LLC has 21 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 3 devices. They overlap on Radiology (21 vs 18). The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 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.
| Philips Ultrasound | Samsung Medison | |
|---|---|---|
| AI devices | 21 | 18 |
| Share of the FDA AI list | 1.3% | 1.1% |
| First decision | May 12, 2023 | May 13, 2021 |
| Latest decision | June 29, 2026 | January 5, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (21) | Radiology (18) |
| Top product code | IYN (20) | IYN (18) |
| 510(k) | 21 | 18 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 1 |
Year by year
| Year | Philips Ultrasound | Samsung Medison |
|---|---|---|
| 2026 | 5 | 1 |
| 2025 | 9 | 2 |
| 2024 | 5 | 5 |
| 2023 | 2 | 4 |
| 2022 | 0 | 3 |
| 2021 | 0 | 3 |
Where they overlap
Shared product codes
Latest from Philips Ultrasound
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
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
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Philips Ultrasound or Samsung Medison?
Philips Ultrasound, LLC has 21 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 3 devices.
Do Philips Ultrasound and Samsung Medison have AI devices in the same specialty?
They overlap on Radiology (21 vs 18).
Which company has the more recent AI clearance?
The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 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?
Philips Ultrasound has 5 devices dated 2026, and Samsung Medison has 1.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (20 vs 18).
Cite as: AI Device Radar, “Philips Ultrasound vs Samsung Medison: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/philips-ultrasound-llc/samsung-medison-co-ltd (FDA list through 2026-06-29).