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.”

AlgorithmTwo new methods (algorithms) for synthetic CT generation will be included.

source quote (p.7)

“Two new methods (algorithms) for synthetic CT generation will be included.”

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)

Standalone

sample size not stated

endpoints: demonstrates that the dose computation adequate for clinical use.

Standalone

sample size not stated

endpoints: demonstrates that the dose computation adequate for clinical use.

Standalone

sample size not stated

endpoints: demonstrates that the 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-50%

vs code's own 3-yr baseline

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). 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).