Philips Ultrasound vs Siemens Medical Solutions USA: FDA-cleared AI devices
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 46 devices. They overlap on Radiology (21 vs 67). The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 2026. The latest from Siemens Medical Solutions USA, Inc. is syngo.CT Coronary Cockpit on June 25, 2026.
| Philips Ultrasound | Siemens Medical Solutions USA | |
|---|---|---|
| AI devices | 21 | 67 |
| Share of the FDA AI list | 1.3% | 4.2% |
| First decision | May 12, 2023 | January 24, 2014 |
| Latest decision | June 29, 2026 | June 25, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (21) | Radiology (67) |
| Top product code | IYN (20) | LNH (17) |
| 510(k) | 21 | 66 |
| De Novo | 0 | 0 |
| PMA | 0 | 1 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Philips Ultrasound | Siemens Medical Solutions USA |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 9 | 4 |
| 2024 | 5 | 12 |
| 2023 | 2 | 10 |
| 2022 | 0 | 15 |
| 2021 | 0 | 5 |
| 2020 | 0 | 9 |
| 2019 | 0 | 5 |
| 2017 | 0 | 1 |
| 2014 | 0 | 1 |
Where they overlap
Shared product codes
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic20 / 5QIHAutomated Radiological Image Processing Software1 / 12Latest 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 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, Philips Ultrasound or Siemens Medical Solutions USA?
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 46 devices.
Do Philips Ultrasound and Siemens Medical Solutions USA have AI devices in the same specialty?
They overlap on Radiology (21 vs 67).
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 Siemens Medical Solutions USA, Inc. is syngo.CT Coronary Cockpit on June 25, 2026.
How many AI devices did each company clear in 2026?
Philips Ultrasound has 5 devices dated 2026, and Siemens Medical Solutions USA has 5.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (20 vs 5), QIH (1 vs 12).
Cite as: AI Device Radar, “Philips Ultrasound vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/philips-ultrasound-llc/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).