Ge Medical Systems vs Siemens Medical Solutions USA: FDA-cleared AI devices
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 43 devices. They overlap on Radiology (24 vs 67). The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Ge Medical Systems, LLC is Enhanced Boundary for PCCT on June 24, 2026.
| Ge Medical Systems | Siemens Medical Solutions USA | |
|---|---|---|
| AI devices | 24 | 67 |
| Share of the FDA AI list | 1.5% | 4.2% |
| First decision | January 18, 2019 | January 24, 2014 |
| Latest decision | June 24, 2026 | June 25, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (24) | Radiology (67) |
| Top product code | LNH (10) | LNH (17) |
| 510(k) | 24 | 66 |
| De Novo | 0 | 0 |
| PMA | 0 | 1 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Ge Medical Systems | Siemens Medical Solutions USA |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 5 | 4 |
| 2024 | 1 | 12 |
| 2023 | 3 | 10 |
| 2022 | 1 | 15 |
| 2021 | 4 | 5 |
| 2020 | 2 | 9 |
| 2019 | 3 | 5 |
| 2017 | 0 | 1 |
| 2014 | 0 | 1 |
Where they overlap
Shared product codes
LNHSystem, Nuclear Magnetic Resonance Imaging10 / 17JAKSystem, X-Ray, Tomography, Computed8 / 14QIHAutomated Radiological Image Processing Software2 / 12KPSSystem, Tomography, Computed, Emission1 / 3QKBRadiological Image Processing Software For Radiation Therapy1 / 2Latest 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 Siemens Medical Solutions USA
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Ge Medical Systems or Siemens Medical Solutions USA?
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 43 devices.
Do Ge Medical Systems and Siemens Medical Solutions USA have AI devices in the same specialty?
They overlap on Radiology (24 vs 67).
Which company has the more recent AI clearance?
The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Ge Medical Systems, LLC is Enhanced Boundary for PCCT on June 24, 2026.
How many AI devices did each company clear in 2026?
Ge Medical Systems has 5 devices dated 2026, and Siemens Medical Solutions USA has 5.
Do they share FDA product codes?
Yes. The codes on both lists include LNH (10 vs 17), JAK (8 vs 14), QIH (2 vs 12), KPS (1 vs 3).
Cite as: AI Device Radar, “Ge Medical Systems vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-llc/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).