Ge Medical Systems vs GE Medical Systems Ultrasound and Primary Care Diagnostics: FDA-cleared AI devices
GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 7 devices. They overlap on Radiology (24 vs 31). The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 2026. The latest from GE Medical Systems Ultrasound and Primary Care Diagnostics 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 on March 24, 2026.
On the FDA list these are separate applicants, both filed under a GE name. Ge Medical Systems, LLC and GE Medical Systems Ultrasound and Primary Care Diagnostics are not added together on this page.
| Ge Medical Systems | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
|---|---|---|
| AI devices | 24 | 31 |
| Share of the FDA AI list | 1.5% | 1.9% |
| First decision | January 18, 2019 | May 2, 2018 |
| Latest decision | June 24, 2026 | March 24, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (24) | Radiology (31) |
| Top product code | LNH (10) | IYN (28) |
| 510(k) | 24 | 31 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 3 |
Year by year
| Year | Ge Medical Systems | GE Medical Systems Ultrasound and Primary Care Diagnostics |
|---|---|---|
| 2026 | 5 | 3 |
| 2025 | 5 | 10 |
| 2024 | 1 | 3 |
| 2023 | 3 | 3 |
| 2022 | 1 | 6 |
| 2021 | 4 | 1 |
| 2020 | 2 | 3 |
| 2019 | 3 | 0 |
| 2018 | 0 | 2 |
Where they overlap
Shared product codes
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 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
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Ge Medical Systems or GE Medical Systems Ultrasound and Primary Care Diagnostics?
GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 7 devices.
Do Ge Medical Systems and GE Medical Systems Ultrasound and Primary Care Diagnostics have AI devices in the same specialty?
They overlap on Radiology (24 vs 31).
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 GE Medical Systems Ultrasound and Primary Care Diagnostics 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 on March 24, 2026.
How many AI devices did each company clear in 2026?
Ge Medical Systems has 5 devices dated 2026, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 3.
Do they share FDA product codes?
Yes. The codes on both lists include QIH (2 vs 2).
Cite as: AI Device Radar, “Ge Medical Systems vs GE Medical Systems Ultrasound and Primary Care Diagnostics: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-llc/ge-medical-systems-ultrasound-and-primary-care-diagnostics (FDA list through 2026-06-29).