Ge Medical Systems vs Philips Ultrasound: FDA-cleared AI devices
Ge Medical Systems, LLC has 24 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 3 devices. They overlap on Radiology (24 vs 21). The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 2026. The latest from Ge Medical Systems, LLC is Enhanced Boundary for PCCT on June 24, 2026.
| Ge Medical Systems | Philips Ultrasound | |
|---|---|---|
| AI devices | 24 | 21 |
| Share of the FDA AI list | 1.5% | 1.3% |
| First decision | January 18, 2019 | May 12, 2023 |
| Latest decision | June 24, 2026 | June 29, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (24) | Radiology (21) |
| Top product code | LNH (10) | IYN (20) |
| 510(k) | 24 | 21 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Ge Medical Systems | Philips Ultrasound |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 5 | 9 |
| 2024 | 1 | 5 |
| 2023 | 3 | 2 |
| 2022 | 1 | 0 |
| 2021 | 4 | 0 |
| 2020 | 2 | 0 |
| 2019 | 3 | 0 |
Where they overlap
Shared product codes
Latest from Ge Medical Systems
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC · Radiology
- Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC · Radiology
- SIGNA BoltGe Medical Systems, LLC · Radiology
- SIGNA Sprint SelectGe Medical Systems, LLC · Radiology
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
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Ge Medical Systems or Philips Ultrasound?
Ge Medical Systems, LLC has 24 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 3 devices.
Do Ge Medical Systems and Philips Ultrasound have AI devices in the same specialty?
They overlap on Radiology (24 vs 21).
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 Ge Medical Systems, LLC is Enhanced Boundary for PCCT on June 24, 2026.
How many AI devices did each company clear in 2026?
Ge Medical Systems has 5 devices dated 2026, and Philips Ultrasound has 5.
Do they share FDA product codes?
Yes. The codes on both lists include QIH (2 vs 1).
Cite as: AI Device Radar, “Ge Medical Systems vs Philips Ultrasound: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-llc/philips-ultrasound-llc (FDA list through 2026-06-29).