Aidoc Medical vs Samsung Medison: FDA-cleared AI devices
Aidoc Medical, Ltd. has 35 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 17 devices. They overlap on Radiology (35 vs 18). The newer decision is BriefCase-Triage from Aidoc Medical, Ltd. on May 14, 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.
| Aidoc Medical | Samsung Medison | |
|---|---|---|
| AI devices | 35 | 18 |
| Share of the FDA AI list | 2.2% | 1.1% |
| First decision | August 1, 2018 | May 13, 2021 |
| Latest decision | May 14, 2026 | January 5, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (35) | Radiology (18) |
| Top product code | QAS (25) | IYN (18) |
| 510(k) | 35 | 18 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 1 |
Year by year
| Year | Aidoc Medical | Samsung Medison |
|---|---|---|
| 2026 | 4 | 1 |
| 2025 | 3 | 2 |
| 2024 | 5 | 5 |
| 2023 | 5 | 4 |
| 2022 | 10 | 3 |
| 2021 | 1 | 3 |
| 2020 | 3 | 0 |
| 2019 | 3 | 0 |
| 2018 | 1 | 0 |
Where they overlap
Latest from Aidoc Medical
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · 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, Aidoc Medical or Samsung Medison?
Aidoc Medical, Ltd. has 35 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 17 devices.
Do Aidoc Medical and Samsung Medison have AI devices in the same specialty?
They overlap on Radiology (35 vs 18).
Which company has the more recent AI clearance?
The newer decision is BriefCase-Triage from Aidoc Medical, Ltd. on May 14, 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?
Aidoc Medical has 4 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, “Aidoc Medical vs Samsung Medison: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/aidoc-medical-ltd/samsung-medison-co-ltd (FDA list through 2026-06-29).