Voxel Dosimetry (00859873006226)

K243919

Hermes Medical Solutions AB · cleared 2025-07-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Voxel Dosimetry is a software application for nuclear medicine.”
Algorithmdeep learning based semi-automatic segmentation
source quote (p.6)
“Voxel Dosimetry can perform absorbed dose calculations at an organ level (VOI) for right and left kidneys, right and left lungs, liver and spleen, utilizing deep learning based semi-automatic segmentation.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (8)

Bench

sample size not stated

standards: FDA's Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions”

Bench

sample size not stated

endpoints: algorithms perform as expected and results were within pre-set acceptance criteria; published statistical methods or are comparison criteria which are consistent with published studies

Bench

sample size not stated

endpoints: results meet the acceptance criteria

Bench

sample size not stated

endpoints: results meet the acceptance criteria

Bench

sample size not stated

endpoints: reproducibility shows that the results meet the acceptance criteria

Bench

sample size not stated

endpoints: results meet the acceptance criteria

Bench

sample size not stated

endpoints: results meet the acceptance criteria

Bench

sample size not stated

endpoints: results meet the acceptance criteria

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K243919