Canon Medical Systems vs Siemens Medical Solutions USA: FDA-cleared AI devices
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Canon Medical Systems Corporation has 42. The gap is 25 devices. They overlap on Radiology (42 vs 67). The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
| Canon Medical Systems | Siemens Medical Solutions USA | |
|---|---|---|
| AI devices | 42 | 67 |
| Share of the FDA AI list | 2.6% | 4.2% |
| First decision | June 12, 2019 | January 24, 2014 |
| Latest decision | May 20, 2026 | June 25, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (67) |
| Top product code | JAK (18) | LNH (17) |
| 510(k) | 42 | 66 |
| De Novo | 0 | 0 |
| PMA | 0 | 1 |
| Dated 2026 | 4 | 5 |
Year by year
| Year | Canon Medical Systems | Siemens Medical Solutions USA |
|---|---|---|
| 2026 | 4 | 5 |
| 2025 | 6 | 4 |
| 2024 | 6 | 12 |
| 2023 | 7 | 10 |
| 2022 | 5 | 15 |
| 2021 | 7 | 5 |
| 2020 | 5 | 9 |
| 2019 | 2 | 5 |
| 2017 | 0 | 1 |
| 2014 | 0 | 1 |
Where they overlap
Shared product codes
JAKSystem, X-Ray, Tomography, Computed18 / 14LNHSystem, Nuclear Magnetic Resonance Imaging12 / 17QIHAutomated Radiological Image Processing Software1 / 12IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5 / 5KPSSystem, Tomography, Computed, Emission3 / 3Latest 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 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, Canon Medical Systems or Siemens Medical Solutions USA?
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Canon Medical Systems Corporation has 42. The gap is 25 devices.
Do Canon Medical Systems and Siemens Medical Solutions USA have AI devices in the same specialty?
They overlap on Radiology (42 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 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 Siemens Medical Solutions USA has 5.
Do they share FDA product codes?
Yes. The codes on both lists include JAK (18 vs 14), LNH (12 vs 17), QIH (1 vs 12), IYN (5 vs 5).
Cite as: AI Device Radar, “Canon Medical Systems vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).