Company comparison

GE Medical Systems Ultrasound and Primary Care Diagnostics vs Shanghai United Imaging Healthcare: FDA-cleared AI devices

GE Medical Systems Ultrasound and Primary Care Diagnostics31 AI devicesVSShanghai United Imaging Healthcare33 AI devices

Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 2 devices. They overlap on Radiology (31 vs 33). The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 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	Shanghai United Imaging Healthcare
AI devices	31	33
Share of the FDA AI list	1.9%	2%
First decision	May 2, 2018	May 5, 2020
Latest decision	March 24, 2026	May 22, 2026
Specialties	1	1
Largest specialty	Radiology (31)	Radiology (33)
Top product code	IYN (28)	LNH (10)
510(k)	31	33
De Novo	0	0
PMA	0	0
Dated 2026	3	5

Year by year

Year	GE Medical Systems Ultrasound and Primary Care Diagnostics	Shanghai United Imaging Healthcare
2026	3	5
2025	10	10
2024	3	7
2023	3	6
2022	6	0
2021	1	1
2020	3	4
2018	2	0

Where they overlap

Radiology31 / 33

Shared product codes

QIHAutomated Radiological Image Processing Software2 / 6 LLZSystem, Image Processing, Radiological1 / 1

Latest from GE Medical Systems Ultrasound and Primary Care Diagnostics

Latest from Shanghai United Imaging Healthcare

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Frequently asked questions

Who has more FDA-cleared AI devices, GE Medical Systems Ultrasound and Primary Care Diagnostics or Shanghai United Imaging Healthcare?

Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and GE Medical Systems Ultrasound and Primary Care Diagnostics has 31. The gap is 2 devices.

Do GE Medical Systems Ultrasound and Primary Care Diagnostics and Shanghai United Imaging Healthcare have AI devices in the same specialty?

They overlap on Radiology (31 vs 33).

Which company has the more recent AI clearance?

The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 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 Shanghai United Imaging Healthcare has 5.

Do they share FDA product codes?

Yes. The codes on both lists include QIH (2 vs 6), LLZ (1 vs 1).

Cite as: AI Device Radar, “GE Medical Systems Ultrasound and Primary Care Diagnostics vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-ultrasound-and-primary-care-diagnostics/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).