Roundup · ranked by clearances

Best FDA-cleared AI radiology devices (2026)

The companies with the most FDA-cleared AI radiology devices through June 29, 2026 are Siemens Medical Solutions USA, Inc. (67), Canon Medical Systems Corporation (42) and Aidoc Medical, Ltd. (35). This is a count of final decisions on the FDA list. It is not a ranking of clinical performance.

How this ranking works

Each row is one applicant name on the FDA AI-enabled device list, limited to devices whose lead review panel is Radiology. Affiliated companies are not merged. A company needs at least two radiology devices to appear in the top list. 229 other companies have exactly one. The full catalog is the radiology specialty page; 2026 alone is FDA-cleared AI devices for radiology 2026.

Top companies

  1. 1

    Siemens Medical Solutions USA, Inc.

    Siemens Medical Solutions USA, Inc. has 67 FDA-listed AI radiology devices (5.4% of this specialty), with decisions from 2014–2026. The latest is syngo.CT Coronary Cockpit (K253786) on June 25, 2026. Most common product code: LNH (System, Nuclear Magnetic Resonance Imaging), 17 devices.

  2. 2

    Canon Medical Systems Corporation

    Canon Medical Systems Corporation has 42 FDA-listed AI radiology devices (3.4% of this specialty), with decisions from 2019–2026. The latest is Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) on May 20, 2026. Most common product code: JAK (System, X-Ray, Tomography, Computed), 18 devices.

  3. 3

    Aidoc Medical, Ltd.

    Aidoc Medical, Ltd. has 35 FDA-listed AI radiology devices (2.8% of this specialty), with decisions from 2018–2026. The latest is BriefCase-Triage (K261317) on May 14, 2026. Most common product code: QAS (Radiological Computer-Assisted Triage And Notification Software), 25 devices.

  4. 4

    Shanghai United Imaging Healthcare Co., Ltd.

    Shanghai United Imaging Healthcare Co., Ltd. has 33 FDA-listed AI radiology devices (2.7% of this specialty), with decisions from 2020–2026. The latest is uMR Astra (K260113) on May 22, 2026. Most common product code: LNH (System, Nuclear Magnetic Resonance Imaging), 10 devices.

  5. 5

    GE Medical Systems Ultrasound and Primary Care Diagnostics

    GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 FDA-listed AI radiology devices (2.5% of this specialty), with decisions from 2018–2026. The latest 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 (K260673) on March 24, 2026. Most common product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic), 28 devices.

  6. 6

    Ge Medical Systems, LLC

    Ge Medical Systems, LLC has 24 FDA-listed AI radiology devices (2% of this specialty), with decisions from 2019–2026. The latest is Enhanced Boundary for PCCT (K253560) on June 24, 2026. Most common product code: LNH (System, Nuclear Magnetic Resonance Imaging), 10 devices.

  7. 7

    Philips Ultrasound, LLC

    Philips Ultrasound, LLC has 21 FDA-listed AI radiology devices (1.7% of this specialty), with decisions from 2023–2026. The latest is Alturion Series Diagnostic Ultrasound System (K260667) on June 29, 2026. Most common product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic), 20 devices.

  8. 8

    Samsung Medison Co., Ltd.

    Samsung Medison Co., Ltd. has 18 FDA-listed AI radiology devices (1.5% of this specialty), with decisions from 2021–2026. The latest is HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (K252018) on January 5, 2026. Most common product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic), 18 devices.

Newest radiology clearances

The six most recent radiology decisions on the list. See every radiology device dated 2026 · All specialties in 2026

Head-to-head

Canon Medical Systems vs Siemens Medical Solutions USAAidoc Medical vs Siemens Medical Solutions USAShanghai United Imaging Healthcare vs Siemens Medical Solutions USAGE Medical Systems Ultrasound and Primary Care Diagnostics vs Siemens Medical Solutions USAGe Medical Systems vs Siemens Medical Solutions USAPhilips Ultrasound vs Siemens Medical Solutions USASamsung Medison vs Siemens Medical Solutions USAAidoc Medical vs Canon Medical Systems

All company comparisons

Cardiovascular154Neurology73Anesthesiology30Gastroenterology-Urology27Hematology22

Frequently asked questions

Which company has the most FDA-cleared AI radiology devices?

Siemens Medical Solutions USA, Inc. has the most, with 67 (5.4% of radiology devices on the list). Next are Canon Medical Systems Corporation (42) and Aidoc Medical, Ltd. (35).

How many FDA-cleared AI radiology devices are there?

The FDA AI-device list has 1,230 devices with Radiology as the lead review panel, from 432 companies, through June 29, 2026.

Is this a ranking of the best AI radiology devices clinically?

No. Companies are ordered by how many FDA final decisions they have on the AI-enabled device list. That measures how many authorized products an applicant has, not accuracy, safety, or which device to buy.

Which AI radiology device was cleared most recently?

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd. (K253628), decided on June 29, 2026.

How many AI radiology devices were cleared in 2026?

135 radiology devices have a 2026 decision date, through June 29, 2026.

Cite as: AI Device Radar, “Best FDA-cleared AI radiology devices (2026),” https://ai-device-radar.vercel.app/best/radiology (FDA list through 2026-06-29).