Canon Medical Systems vs Samsung Medison: FDA-cleared AI devices
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 24 devices. They overlap on Radiology (42 vs 18). The newer decision is Aquilion ONE (TSX-308A/TSX-306A) V2.0 from Canon Medical Systems Corporation on May 20, 2026. The latest from Samsung Medison Co., Ltd. is HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System on January 5, 2026.
| Canon Medical Systems | Samsung Medison | |
|---|---|---|
| AI devices | 42 | 18 |
| Share of the FDA AI list | 2.6% | 1.1% |
| First decision | June 12, 2019 | May 13, 2021 |
| Latest decision | May 20, 2026 | January 5, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (18) |
| Top product code | JAK (18) | IYN (18) |
| 510(k) | 42 | 18 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 1 |
Year by year
| Year | Canon Medical Systems | Samsung Medison |
|---|---|---|
| 2026 | 4 | 1 |
| 2025 | 6 | 2 |
| 2024 | 6 | 5 |
| 2023 | 7 | 4 |
| 2022 | 5 | 3 |
| 2021 | 7 | 3 |
| 2020 | 5 | 0 |
| 2019 | 2 | 0 |
Where they overlap
Shared product codes
Latest 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 Samsung Medison
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Canon Medical Systems or Samsung Medison?
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 24 devices.
Do Canon Medical Systems and Samsung Medison have AI devices in the same specialty?
They overlap on Radiology (42 vs 18).
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 Samsung Medison Co., Ltd. is HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System on January 5, 2026.
How many AI devices did each company clear in 2026?
Canon Medical Systems has 4 devices dated 2026, and Samsung Medison has 1.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (5 vs 18).
Cite as: AI Device Radar, “Canon Medical Systems vs Samsung Medison: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/samsung-medison-co-ltd (FDA list through 2026-06-29).