RayStation 12A
K222312RaySearch Laboratories AB (publ) · cleared 2023-03-29 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“RayStation is a software system for radiation therapy and medical oncology.”
source quote (p.4)
“A scientific basis for the device is the implementation of peer reviewed algorithms of plan parameter optimization and photon and particle dose calculation.”
source quote (p.11)
“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.)”
source quote (p.7)
“Both systems are compliant with the requirements listed in the FDA guideline 1825 "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".”
Validation studies (4)
Bench
sample size not stated
endpoints: The SOBP distal fall-off of the central axis depth dose curve; 95% and 98% of the computed depth dose values with Gamma pass rates
Bench
sample size not stated
endpoints: For a 3D-CRT plan, the merged beams' MU shall agree with original beams' MU.; Merged beams' segments shall keep original shapes.; MU and segment weights after split are subdivided correctly and that split beams are managed correctly in terms of ordering and ROI handling.
Bench
sample size not stated
endpoints: Measured doses; Doses computed in two major competing TPS; Doses computed with an independent Monte Carlo software; The dose engine accuracy for a variety of sources given that the input data is correct.; Measurement from EQUAL-ESTRO relates computed dose to delivered dose for a setup with three dwell positions.; Comparison to an independent and TG43 compliant treatment planning system is used to further validate the correct superposition of dose from a large number of dwell positions.; Comparison to an independent Monte Carlo system decouples the dependence to the TG43 formalism and provides a fully independent validation of a complete treatment plan.
Bench
sample size not stated
endpoints: The fraction of the calculated dose data points for comparison with previous RayStation dose that fail has been evaluated, and the fraction of the calculated dose data points for comparison to BEAMnrc/egs++ that fail has been evaluated.; Validation of the new dose engine has been performed which demonstrates that the dose computation is adequate for clinical use.
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).