The State of FDA AI Clearances
Every count on this page is computed live from the Transparency Registry, which mirrors openFDA public records for the FDA's 9 AI-specific 510(k) product codes. The numbers refresh with the weekly sync. Facts only: this report counts public records and never evaluates any product.
Clearances by year
Striped bar = year in progress. Decision dates from public 510(k) records.
2026 has already recorded 102 clearances against 127 in all of 2025. Annual clearances under these codes have risen every full year on record.
Clearances by quarter
40 organisations received their first clearance under these codes in 2026 so far, out of 266 distinct applicants since 2018. The field is widening, not consolidating into a fixed roster.
By product code
| Code | FDA device name | Clearances |
|---|---|---|
| QIH | Automated Radiological Image Processing Software | 329 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | 87 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 49 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 41 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 39 |
| QBS | Radiological Computer Assisted Detection/Diagnosis Software For Fracture | 11 |
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 9 |
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | 2 |
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | 1 |
Clearances held, by applicant
A count of public records, most-cleared first. Holding more clearances is a fact about volume, not a statement about any product.
| Applicant | First clearance | Clearances |
|---|---|---|
| Aidoc Medical , Ltd. | 2018-08-01 | 34 |
| Siemens Medical Solutions USA, Inc. | 2020-07-30 | 17 |
| Ischemaview, Inc. | 2020-07-09 | 13 |
| Ever Fortune.Ai, Co., Ltd. | 2022-04-04 | 12 |
| Dia Imaging Analysis, Ltd. | 2020-06-23 | 10 |
| DeepHealth, Inc. | 2021-04-16 | 9 |
| Viz. Ai, Inc. | 2020-03-18 | 9 |
| Screenpoint Medical B.V. | 2018-11-21 | 8 |
| Siemens Healthcare GmbH | 2022-04-15 | 8 |
| Mim Software, Inc. | 2020-07-02 | 7 |
Method
The registry mirrors openFDA 510(k) records for the AI-specific product codes the FDA has created since 2018, refreshed weekly by an automated sync. Decision dates, applicants, and product codes are reproduced as published; nothing is edited. A year or quarter in progress is marked as partial. The full row-level dataset is downloadable: CSV · JSON. Counts are CC BY 4.0: reuse them with attribution.
How to cite
A dated snapshot of the row-level dataset is archived with a DOI: 10.5281/zenodo.22651260 — cite that version for reproducibility.
The vendor due-diligence checklist (interactive, stores nothing) · the contract rider (paste-ready, CC BY) · the live clearance report (weekly, citable) · the record verifier.
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