Company comparison

GE Medical Systems Ultrasound and Primary Care Diagnostics vs Siemens Medical Solutions USA: FDA-cleared AI devices

GE Medical Systems Ultrasound and Primary Care Diagnostics31 AI devicesVSSiemens Medical Solutions USA67 AI devices

Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 36 devices. They overlap on Radiology (31 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 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.

	GE Medical Systems Ultrasound and Primary Care Diagnostics	Siemens Medical Solutions USA
AI devices	31	67
Share of the FDA AI list	1.9%	4.2%
First decision	May 2, 2018	January 24, 2014
Latest decision	March 24, 2026	June 25, 2026
Specialties	1	1
Largest specialty	Radiology (31)	Radiology (67)
Top product code	IYN (28)	LNH (17)
510(k)	31	66
De Novo	0	0
PMA	0	1
Dated 2026	3	5

Year by year

Year	GE Medical Systems Ultrasound and Primary Care Diagnostics	Siemens Medical Solutions USA
2026	3	5
2025	10	4
2024	3	12
2023	3	10
2022	6	15
2021	1	5
2020	3	9
2019	0	5
2018	2	0
2017	0	1
2014	0	1

Where they overlap

Radiology31 / 67

Shared product codes

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic28 / 5 QIHAutomated Radiological Image Processing Software2 / 12 LLZSystem, Image Processing, Radiological1 / 4

Latest from GE Medical Systems Ultrasound and Primary Care Diagnostics

Latest from Siemens Medical Solutions USA

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Frequently asked questions

Who has more FDA-cleared AI devices, GE Medical Systems Ultrasound and Primary Care Diagnostics or Siemens Medical Solutions USA?

Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 36 devices.

Do GE Medical Systems Ultrasound and Primary Care Diagnostics and Siemens Medical Solutions USA have AI devices in the same specialty?

They overlap on Radiology (31 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 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 Ultrasound and Primary Care Diagnostics has 3 devices dated 2026, and Siemens Medical Solutions USA has 5.

Do they share FDA product codes?

Yes. The codes on both lists include IYN (28 vs 5), QIH (2 vs 12), LLZ (1 vs 4).

Cite as: AI Device Radar, “GE Medical Systems Ultrasound and Primary Care Diagnostics vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-ultrasound-and-primary-care-diagnostics/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).