Canon Medical Systems vs GE Medical Systems Ultrasound and Primary Care Diagnostics: FDA-cleared AI devices
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 11 devices. They overlap on Radiology (42 vs 31). The newer decision is Aquilion ONE (TSX-308A/TSX-306A) V2.0 from Canon Medical Systems Corporation on May 20, 2026. The latest from GE Medical Systems Ultrasound and Primary Care Diagnostics is LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power on March 24, 2026.
| Canon Medical Systems | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
|---|---|---|
| AI devices | 42 | 31 |
| Share of the FDA AI list | 2.6% | 1.9% |
| First decision | June 12, 2019 | May 2, 2018 |
| Latest decision | May 20, 2026 | March 24, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (31) |
| Top product code | JAK (18) | IYN (28) |
| 510(k) | 42 | 31 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 3 |
Year by year
| Year | Canon Medical Systems | GE Medical Systems Ultrasound and Primary Care Diagnostics |
|---|---|---|
| 2026 | 4 | 3 |
| 2025 | 6 | 10 |
| 2024 | 6 | 3 |
| 2023 | 7 | 3 |
| 2022 | 5 | 6 |
| 2021 | 7 | 1 |
| 2020 | 5 | 3 |
| 2019 | 2 | 0 |
| 2018 | 0 | 2 |
Where they overlap
Shared product codes
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5 / 28QIHAutomated 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 Ultrasound and Primary Care Diagnostics
- LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ E10Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Canon Medical Systems or GE Medical Systems Ultrasound and Primary Care Diagnostics?
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 11 devices.
Do Canon Medical Systems and GE Medical Systems Ultrasound and Primary Care Diagnostics have AI devices in the same specialty?
They overlap on Radiology (42 vs 31).
Which company has the more recent AI clearance?
The newer decision is Aquilion ONE (TSX-308A/TSX-306A) V2.0 from Canon Medical Systems Corporation on May 20, 2026. The latest from GE Medical Systems Ultrasound and Primary Care Diagnostics is LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power on March 24, 2026.
How many AI devices did each company clear in 2026?
Canon Medical Systems has 4 devices dated 2026, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 3.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (5 vs 28), QIH (1 vs 2).
Cite as: AI Device Radar, “Canon Medical Systems vs GE Medical Systems Ultrasound and Primary Care Diagnostics: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/ge-medical-systems-ultrasound-and-primary-care-diagnostics (FDA list through 2026-06-29).