2026-10-15 · Generated from RankToolsMD data
10 new FDA 510(k) clearances since July for vendors we rank
The FDA’s AI-enabled device list still covers decisions only through June 2026. To see what’s happened since, we pulled FDA 510(k) decisions dated July 1 to October 15, 2026 from openFDA and kept only clearances where the applicant is a vendor we rank and the product code matches that vendor’s ranked product. That leaves 10 clearances from 10 companies, touching 7 of our lists. Each number links to the FDA database record.
| Decision date | Device | Applicant | Product code | FDA number | Ranked product and list |
|---|---|---|---|---|---|
| 2026-09-18 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | LLZ | K261855 | Elucid PlaqueIQ Cardiac CT / coronary plaque analysis |
| 2026-08-14 | Transpara (2.1.0) | Screenpoint Medical B.V. | QDQ | K260898 | Transpara Mammography / DBT detection |
| 2026-08-14 | AutoContour (RADAC V6) | Radformation, Inc. | QKB | K262452 | Radformation AutoContour Radiotherapy auto-contouring |
| 2026-08-13 | AIR Recon DL | GE Medical Systems | LNH | K253808 | GE HealthCare AIR Recon DL MRI reconstruction / acceleration |
| 2026-08-06 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | MYN | K261059 | Overjet Dental X-ray caries detection |
| 2026-07-29 | Cleerly Plaque | Cleerly, Inc. | QIH | K261210 | Cleerly Cardiac CT / coronary plaque analysis |
| 2026-07-24 | SwiftMR | Airs Medical, Inc. | QIH | K261349 | SwiftMR MRI reconstruction / acceleration |
| 2026-07-23 | CORE 300 Digital Stethoscope | Eko Health, Inc. | DQD | K261694 | Eko ECG AI analysis |
| 2026-07-15 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | MYN | K260851 | Better Diagnostics Caries Assist Dental X-ray caries detection |
| 2026-07-13 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | QAS | K261085 | RapidAI (Rapid LVO) Stroke / LVO detection |
A few things to keep in mind. A 510(k) clearance covers the indication in that FDA record, which may be a new version, a new feature or a separate product from the same company, so read the record before assuming it applies to the product on our list. These clearances aren’t on the FDA AI-enabled list yet, so we don’t label any of them AI-enabled here. Our rankings don’t change from this post: the lists already credit each of these products for its existing FDA record.
Related clearance outside our lists
- Epic Systems Corporation, Deterioration Index Version 2, 510(k) cleared 2026-09-18 (K260008, product code QNL). It’s in the same area as our Sepsis / deterioration early warning list but isn’t ranked there today.
See all 2026 decisions on the FDA AI-enabled list in our live feed. Also new today: Code lookup (ICD-10/CPT) and Async / e-visits now have five verified tools and are live.