Dose+ (1.0)
K250064Mvision AI Oy · cleared 2025-09-04 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
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).”
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.”
source quote (p.6)
“The software utilizes pre-trained machine learning models that are not modifiable or editable by the end-user.”
Validation studies (3)
Retrospective clinical
n=25 cases · 7 site(s)
endpoints: OAR Mean Dose Difference; Target coverage metrics (homogeneity and conformity indices)
Retrospective clinical
n=26 cases · 6 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
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
- 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). 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).