RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
K240398RaySearch Laboratories AB (PUBL) · cleared 2025-04-04 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.12)
“RayStation is a stand-alone software medical device intended for radiation therapy.”
source quote (p.8)
“The scientific concepts of a treatment planning system are patient and beam modeling, and algorithms for dose calculation and plan parameter optimization. With deep learning segmentation, the user can use trained deep learning models for automatic segmentation of new patient images. (The model training is performed offline on clinical CT and structure data.) For electron beams RayStation calculates dose by the Monte Carlo technique. For photon beams RayStation calculates dose by the point kernel superposition method (a.k.a. Collapsed Cone) or a Monte Carlo algorithm for radiation transport (8.1 onwards). For proton beams RayStation uses either the pencil beam algorithm with the Fermi-Eyges formalism, or a Monte Carlo algorithm for radiation transport (6.0 onwards).”
source quote (p.15)
“Adaptive replanning allows the user to adapt the treatment to a changing patient geometry. Reasons for when a patient is selected for replanning can vary between treatment protocols. Replanning should be performed when the plan is no longer suitable for treatment and when it has become necessary to adapt the plan to the new circumstances.”
source quote (p.26)
“Cybersecurity and Interoperability requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023)". The cybersecurity analysis showed that the cybersecurity risks are mitigated, and the residual risk is acceptable. The devices are secure for use in their intended environment and methods are in place for ensuring security throughout the total product lifecycle.”
Validation studies (2)
Bench
sample size not stated
endpoints: Gamma 2%/2mm pass rate above 90% for proton MC/PB dose computation; Gamma 3%/3mm pass rate above 95% for proton MC/PB dose computation
standards: IEC 61217, IEC 62304, IEC 62366-1, ISO 14971, IEC 62083, IEC 81001-5-1
Retrospective clinical
sample size not stated
endpoints: Gamma 2%/2mm pass rate above 90% for proton MC/PB dose computation; Gamma 3%/3mm pass rate above 95% for proton MC/PB dose computation
standards: IEC 61217, IEC 62304, IEC 62366-1, ISO 14971, IEC 62083, IEC 81001-5-1
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).