Canon Medical Systems vs Philips Ultrasound: FDA-cleared AI devices
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 21 devices. They overlap on Radiology (42 vs 21). The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 2026. The latest from Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
| Canon Medical Systems | Philips Ultrasound | |
|---|---|---|
| AI devices | 42 | 21 |
| Share of the FDA AI list | 2.6% | 1.3% |
| First decision | June 12, 2019 | May 12, 2023 |
| Latest decision | May 20, 2026 | June 29, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (21) |
| Top product code | JAK (18) | IYN (20) |
| 510(k) | 42 | 21 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 5 |
Year by year
| Year | Canon Medical Systems | Philips Ultrasound |
|---|---|---|
| 2026 | 4 | 5 |
| 2025 | 6 | 9 |
| 2024 | 6 | 5 |
| 2023 | 7 | 2 |
| 2022 | 5 | 0 |
| 2021 | 7 | 0 |
| 2020 | 5 | 0 |
| 2019 | 2 | 0 |
Where they overlap
Shared product codes
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5 / 20QIHAutomated Radiological Image Processing Software1 / 1Latest from Canon Medical Systems
- Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · Radiology
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation · Radiology
- Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems Corporation · 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, Canon Medical Systems or Philips Ultrasound?
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 21 devices.
Do Canon Medical Systems and Philips Ultrasound have AI devices in the same specialty?
They overlap on Radiology (42 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 Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
How many AI devices did each company clear in 2026?
Canon Medical Systems has 4 devices dated 2026, and Philips Ultrasound has 5.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (5 vs 20), QIH (1 vs 1).
Cite as: AI Device Radar, “Canon Medical Systems vs Philips Ultrasound: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/philips-ultrasound-llc (FDA list through 2026-06-29).