GE Medical Systems Ultrasound and Primary Care Diagnostics vs Samsung Medison: FDA-cleared AI devices
GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 13 devices. They overlap on Radiology (31 vs 18). The newer decision 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 from GE Medical Systems Ultrasound and Primary Care Diagnostics on March 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 Ultrasound and Primary Care Diagnostics | Samsung Medison | |
|---|---|---|
| AI devices | 31 | 18 |
| Share of the FDA AI list | 1.9% | 1.1% |
| First decision | May 2, 2018 | May 13, 2021 |
| Latest decision | March 24, 2026 | January 5, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (31) | Radiology (18) |
| Top product code | IYN (28) | IYN (18) |
| 510(k) | 31 | 18 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 3 | 1 |
Year by year
| Year | GE Medical Systems Ultrasound and Primary Care Diagnostics | Samsung Medison |
|---|---|---|
| 2026 | 3 | 1 |
| 2025 | 10 | 2 |
| 2024 | 3 | 5 |
| 2023 | 3 | 4 |
| 2022 | 6 | 3 |
| 2021 | 1 | 3 |
| 2020 | 3 | 0 |
| 2018 | 2 | 0 |
Where they overlap
Shared product codes
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
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 Ultrasound and Primary Care Diagnostics or Samsung Medison?
GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 13 devices.
Do GE Medical Systems Ultrasound and Primary Care Diagnostics and Samsung Medison have AI devices in the same specialty?
They overlap on Radiology (31 vs 18).
Which company has the more recent AI clearance?
The newer decision 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 from GE Medical Systems Ultrasound and Primary Care Diagnostics on March 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 Ultrasound and Primary Care Diagnostics has 3 devices dated 2026, and Samsung Medison has 1.
Do they share FDA product codes?
Yes. The codes on both lists include IYN (28 vs 18).
Cite as: AI Device Radar, “GE Medical Systems Ultrasound and Primary Care Diagnostics vs Samsung Medison: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-ultrasound-and-primary-care-diagnostics/samsung-medison-co-ltd (FDA list through 2026-06-29).