Canon Medical Systems vs Ge Medical Systems: FDA-cleared AI devices
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 18 devices. They overlap on Radiology (42 vs 24). The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 2026. The latest from Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
| Canon Medical Systems | Ge Medical Systems | |
|---|---|---|
| AI devices | 42 | 24 |
| Share of the FDA AI list | 2.6% | 1.5% |
| First decision | June 12, 2019 | January 18, 2019 |
| Latest decision | May 20, 2026 | June 24, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (24) |
| Top product code | JAK (18) | LNH (10) |
| 510(k) | 42 | 24 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 5 |
Year by year
| Year | Canon Medical Systems | Ge Medical Systems |
|---|---|---|
| 2026 | 4 | 5 |
| 2025 | 6 | 5 |
| 2024 | 6 | 1 |
| 2023 | 7 | 3 |
| 2022 | 5 | 1 |
| 2021 | 7 | 4 |
| 2020 | 5 | 2 |
| 2019 | 2 | 3 |
Where they overlap
Shared product codes
JAKSystem, X-Ray, Tomography, Computed18 / 8LNHSystem, Nuclear Magnetic Resonance Imaging12 / 10KPSSystem, Tomography, Computed, Emission3 / 1QIHAutomated Radiological Image Processing Software1 / 2Latest 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 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
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Canon Medical Systems or Ge Medical Systems?
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 18 devices.
Do Canon Medical Systems and Ge Medical Systems have AI devices in the same specialty?
They overlap on Radiology (42 vs 24).
Which company has the more recent AI clearance?
The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 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 Ge Medical Systems has 5.
Do they share FDA product codes?
Yes. The codes on both lists include JAK (18 vs 8), LNH (12 vs 10), KPS (3 vs 1), QIH (1 vs 2).
Cite as: AI Device Radar, “Canon Medical Systems vs Ge Medical Systems: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/ge-medical-systems-llc (FDA list through 2026-06-29).