AutoDensity

K251078

Eos Imaging · cleared 2025-11-14 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmAI algorithm
source quote (p.12)
“To assess the standalone performance of the Al algorithm of AutoDensity, the test was performed with:”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Bench

n=3 other

endpoints: BMD precision (CV%); BMD agreement (Bland-Altman bias and LoA)

Retrospective clinical

n=253 patients · 2 site(s)

endpoints: Bland-Altman agreement (bias and LoA)

Standalone

n=129 patients

endpoints: Vertebral Level Identification Accuracy; Spine ROI Accuracy (Dice Coefficient overlap)

Prospective clinical

n=30 patients

endpoints: Precision of AutoDensity BMD measurements (CV%)

Reported performance (3 observations)

ppvas written: “BMD precision CV%”1.5
source quote (p.14)
“Results met the acceptance criterion (CV% < 1.5%), indicating equivalent precision performance to the same phantoms scanned with the reference device.”
ppvas written: “AutoDensity precision CV%”2.23CI [95% CI: 1.78%, 2.98%]
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”
diceas written: “Lower boundary of 95% CI of mean Dice Coefficient”0.8
source quote (p.14)
“Lower boundary of 95% CI of mean Dice Coefficient ≥ 0.80”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251078