Dose+ (1.0)

K250064

Mvision AI Oy · cleared 2025-09-04 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Dose+ is a software-only medical device intended for use by qualified, trained radiation therapy professionals (including but not limited to medical physicists, radiation oncologists, and medical dosimetrists).”
Algorithmmachine learning-based algorithms
source quote (p.4)
“The software uses machine learning-based algorithms to automatically produce 3D dose distributions from patient-specific anatomical geometry and target dose prescription.”
Adaptive (vs locked)No
source quote (p.6)
“The software utilizes pre-trained machine learning models that are not modifiable or editable by the end-user.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

n=51 cases · 7 site(s)

endpoints: OAR Mean Dose Difference; Target coverage metrics (homogeneity and conformity indices)

Prospective clinical

sample size not stated · 4 site(s)

endpoints: Non-inferiority in plan quality (both OAR sparing and target coverage) compared to conventional planning; Reduction in optimization iterations when using Dose+ compared to conventional planning; User acceptance and workflow integration; Statistically significant reduction in optimization iterations (≥20% mean reduction); Non-inferior OAR mean doses (≤10 Gy difference); Non-inferior target coverage (no statistically significant differences); Positive user acceptance from validators; No identified safety issues

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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97049

  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97309

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/K250064