Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AlphatecLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list EOS imaging with 17 510(k) clearances, 7 device recalls and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Nov 14, 2025: AutoDensity.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 14, 2025 | AutoDensityK251078 · QIH | 510(k) clearances |
| Nov 14, 2025 | AutoDensityK251078 · Radiology | AI-enabled devices |
| Aug 15, 2025 | VEA Align; spineEOSK251747 · QIH | 510(k) clearances |
| Aug 15, 2025 | VEA Align; spineEOSK251747 · Radiology | AI-enabled devices |
| Aug 6, 2024 | EOSedgeK233920 · KPR | 510(k) clearances |
| Jun 25, 2024 | VEA Align; spineEOSK240582 · QIH | 510(k) clearances |
| Jun 25, 2024 | VEA Align; spineEOSK240582 · Radiology | AI-enabled devices |
| Jan 5, 2024 | VEA AlignK231917 · QIH | 510(k) clearances |
| Jan 5, 2024 | VEA AlignK231917 · Radiology | AI-enabled devices |
| Oct 24, 2023 | spineEOSK232086 · LLZ | 510(k) clearances |
| Sep 16, 2020 | EOSedgeK202394 · KPR | 510(k) clearances |
| Nov 27, 2019 | EOSedgeK192079 · KPR | 510(k) clearances |
| Feb 17, 2015 | EOS, Digital radiography system used in general radiographic examinations.Class II · When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper | Device recalls |
| Jun 19, 2012 | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.Class II · It was discovered of several generator failures of the EOS System due to failure of its anode controller board that driv | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
