Weekly #1: 7 FDA AI clearances (June 24–29, 2026)
7 AI-enabled medical devices received an FDA decision from June 24, 2026 to June 29, 2026. Radiology accounts for 6 of the 7. The newest is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC (K260667). Decisions run from June 24, 2026 to June 29, 2026.
Highlights
- Every decision in this issue is a 510(k) clearance.
- Product code QIH (Automated Radiological Image Processing Software) accounts for 3 decisions: ADAS 3D from Adas3D Medical S.L., Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd., and syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc.
- The one decision outside radiology is SOMNUM (SOMNUM) (Honeynaps Co., Ltd., neurology).
- Philips Ultrasound, LLC, Siemens Medical Solutions USA, Inc., and Ge Medical Systems, LLC are in this issue. Each has at least 15 AI devices on the full FDA list.
- Two companies received their first AI-device decision on the FDA list: Honeynaps Co., Ltd. and Agada Medical, Ltd.
- Devices dated 2026 make up 181 of the 1,614 AI-enabled devices on the FDA list, through June 29, 2026.
The 7 clearances
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- ADAS 3DAdas3D Medical S.L. · Radiology
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd. · Radiology
- SOMNUM (SOMNUM)Honeynaps Co., Ltd. · Neurology
- MammoScreen® (5)Therapixel · Radiology
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
Companies in this issue
Frequently asked questions
How many AI medical devices received an FDA decision between June 24, 2026 and June 29, 2026?
The FDA list shows 7 AI-enabled device decisions between June 24, 2026 and June 29, 2026. 510(k): 7. The newest is Alturion Series Diagnostic Ultrasound System (K260667) from Philips Ultrasound, LLC.
Which specialty had the most new AI clearances in issue #1?
Radiology had the most, with 6 of 7. Next: Neurology (1).
Which companies are in AI Device Radar Weekly #1?
Adas3D Medical S.L., Agada Medical, Ltd., Ge Medical Systems, LLC, Honeynaps Co., Ltd., Philips Ultrasound, LLC, Siemens Medical Solutions USA, Inc., and Therapixel.
Were there De Novo or PMA decisions in this issue?
No. All 7 decisions were 510(k) clearances.
How many AI devices has the FDA authorized in 2026?
The FDA list has 181 AI-enabled devices with a 2026 decision date, through June 29, 2026. The full list has 1,614 devices.
Cite as: AI Device Radar, “Weekly #1: 7 FDA AI clearances (June 24–29, 2026),” https://ai-device-radar.vercel.app/newsletter/1 (FDA list through 2026-06-29).
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