RayStation 11B

K220141

RaySearch Laboratories AB (publ) · cleared 2022-04-15 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“RayStation is a software system for radiation therapy and medical oncology.”
AlgorithmThe computation of the EQD2 dose uses the biological linear quadratic model. Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans.
source quote (p.6)
“EQD2 dose computation (new) - From photon and/or brachy fraction doses, it is possible to compute, deform and accumulate the two Gray equivalent (EQD2) dose. The computation of the EQD2 dose uses the biological linear quadratic model, which is also the basis for the already released biological optimization and evaluation functionality. Generation of synthetic CT from CBCT (new) - Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

sample size not stated

endpoints: dose computation adequate for clinical use

Bench

sample size not stated

endpoints: dose computation adequate for clinical use

Bench

sample size not stated

endpoints: dose computation 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

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/K220141