A quarter of the devices on the FDA's AI list are filed under scanner product codes
The 1,614 devices on the FDA's AI-Enabled Medical Device List by FDA product code, grouped into those filed under a scanner's product code (408) and all others (1,206)
Show the numbers as a table
| Kind of device | FDA product code | Value | Note |
|---|---|---|---|
| Scanner codes | Ultrasound | 137 | Ultrasound systems 137 (FDA device names: System, Imaging, Pulsed Doppler, Ultrasonic 124, System, Imaging, Pulsed Echo, Ultrasonic 12, Ultrasound Imaging For Vascular Access For Hemodialysis 1) |
| Scanner codes | CT | 103 | CT scanners 103 (FDA device names: System, X-Ray, Tomography, Computed 103) |
| Scanner codes | MRI | 100 | MRI systems 100 (FDA device names: System, Nuclear Magnetic Resonance Imaging 100) |
| Scanner codes | Other scanners | 68 | X-ray and fluoroscopy systems 30 (FDA device names: Interventional Fluoroscopic X-Ray System 15, System, X-Ray, Stationary 6, System, X-Ray, Fluoroscopic, Image-Intensified 4, Solid State X-Ray Imager (Flat Panel/Digital Imager) 3, Image-Intensified Fluoroscopic X-Ray System, Mobile 1, System, X-Ray, Mobile 1); PET and SPECT scanners 28 (FDA device names: System, Tomography, Computed, Emission 26, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance 2); Other imaging systems 10 (FDA device names: System, Imaging, Optical Coherence Tomography (Oct) 4, Digital Breast Tomosynthesis 2, Densitometer, Bone 2, Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer 1, Optoacoustic Imaging System 1) |
| Other codes | Image software | 305 | FDA device name: Automated Radiological Image Processing Software |
| Other codes | Image systems | 161 | FDA device name: System, Image Processing, Radiological |
| Other codes | Triage software | 86 | FDA device name: Radiological Computer-Assisted Triage And Notification Software |
| Other codes | Radiation therapy software | 46 | FDA device name: Radiological Image Processing Software For Radiation Therapy |
| Other codes | Image analyzers | 43 | FDA device name: Analyzer, Medical Image |
| Other codes | Lesion prioritization | 40 | FDA device name: Radiological Computer-Assisted Prioritization Software For Lesions |
| Other codes | 157 other codes | 525 | 157 product codes with 1 to 36 devices each |
About the data
- Sources
- FDA, Artificial Intelligence-Enabled Medical Devices (opens in a new tab)The list (CSV), content current as of September 4, 2026: Date of Final Decision, Submission Number, Panel (Lead), Primary Product Code
- FDA, product classification file (opens in a new tab)foiclass.txt (October 26, 2026): PRODUCTCODE, DEVICENAME, DEVICECLASS
- Method
- Kent Applied joined each device on the FDA's AI-Enabled Medical Device List (the version current as of September 4, 2026: 1,614 devices with final decisions from September 29, 1995, to June 29, 2026) to its record in the FDA's 510(k), PMA and product classification files by submission number. The FDA says the list is not a comprehensive resource of AI-enabled devices. The product code is the list's "Primary Product Code", named from the FDA's product classification file. The scanner group is 18 product codes whose FDA names describe a scanner or an imaging detector (ultrasound, CT, MRI, PET and SPECT, x-ray and fluoroscopy, breast tomosynthesis, bone densitometry, optical coherence tomography and optoacoustic imaging), chosen by Kent Applied from the FDA's name for each code. Some devices filed under these codes are software sold for a scanner, such as image reconstruction.
- Published
Free to share and embed with credit to Kent Applied (CC BY 4.0). The source data keeps its own terms.
Related charts
- From research
About one FDA 510(k) clearance in ten is now for a device on the AI list
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
More than half of the FDA's 2025 clearances tagged radiology were for AI-listed devices
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, 510(k) releasable files - From research
Three in four AI-listed devices are in the radiology panel; its share peaked in 2020
FDA, Artificial Intelligence-Enabled Medical Devices - From research
40 devices on the FDA's AI list came through De Novo grants, each a new device type
FDA, Artificial Intelligence-Enabled Medical Devices; FDA, product classification file; FDA, De Novo Classification Request
Sources for the figures above: FDA, De Novo Classification Request (opens in a new tab).
Book a 20-minute call
Tyler Kent can measure a question like this one in your own data. Start with a short call.
Prefer to skip the call? Get a written proposal
Or email tyler@kentapplied.com.