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.6)
“Voxel Dosimetry is a standalone software application designed to assist the user in absorbed dose calculations at voxel level using a single volumetric image or a time series of images taken after the treatment dose is given to the patient.”
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 (6)

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; 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); 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/K243919