Ge Medical Systems vs Samsung Medison: FDA-cleared AI devices
Ge Medical Systems, LLC has 24 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 6 devices. They overlap on Radiology (24 vs 18). The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 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.
| Ge Medical Systems | Samsung Medison | |
|---|---|---|
| AI devices | 24 | 18 |
| Share of the FDA AI list | 1.5% | 1.1% |
| First decision | January 18, 2019 | May 13, 2021 |
| Latest decision | June 24, 2026 | January 5, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (24) | Radiology (18) |
| Top product code | LNH (10) | IYN (18) |
| 510(k) | 24 | 18 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 1 |
Year by year
| Year | Ge Medical Systems | Samsung Medison |
|---|---|---|
| 2026 | 5 | 1 |
| 2025 | 5 | 2 |
| 2024 | 1 | 5 |
| 2023 | 3 | 4 |
| 2022 | 1 | 3 |
| 2021 | 4 | 3 |
| 2020 | 2 | 0 |
| 2019 | 3 | 0 |
Where they overlap
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
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, Ge Medical Systems or Samsung Medison?
Ge Medical Systems, LLC has 24 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 6 devices.
Do Ge Medical Systems and Samsung Medison have AI devices in the same specialty?
They overlap on Radiology (24 vs 18).
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 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?
Ge Medical Systems has 5 devices dated 2026, and Samsung Medison has 1.
Do they share FDA product codes?
No product code appears on both applicants' AI-device lists.
Cite as: AI Device Radar, “Ge Medical Systems vs Samsung Medison: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-llc/samsung-medison-co-ltd (FDA list through 2026-06-29).