AutoDensity
K251078Eos Imaging · cleared 2025-11-14 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“AutoDensity is a post-processing software intended to estimate spine Bone Mineral Density (BMD) from EOSedge dual energy images for orthopedic pre-surgical assessment applications.”
source quote (p.12)
“To assess the standalone performance of the AI algorithm of AutoDensity, the test was performed with:”
Validation studies (4)
Standalone
n=129 patients
endpoints: Vertebral Level Identification, assessed based on the % of vertebral levels correctly identified compared to ground truth; Spine ROI Accuracy, assessed by Dice Coefficient overlap between algorithm predicted ROIs and radiologist ground truth
Bench
n=3 other
endpoints: BMD precision; BMD agreement
Prospective clinical
n=30 patients
endpoints: Precision of AutoDensity BMD measurements
Retrospective clinical
n=253 patients
endpoints: Bland-Altman agreement between AutoDensity and the reference device BMD measurements
Reported performance (1 observation)
source quote (p.14)
“AutoDensity precision CV% was 2.23% [95% CI: 1.78%, 2.98%] with the patient in a weight-bearing standing position”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).