RayStation

K190387

RaySearch Laboratories AB (publ) · cleared 2019-06-19 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“RayStation is a software system designed for treatment planning and analysis of radiation therapy.”

Algorithmmachine learning planning and segmentation

source quote (p.4)

“The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K240398 (decision 2025-04-04) from RaySearch Laboratories AB (PUBL) for a matching device line ("RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K240398
re_clearance
The FDA AI/ML device list shows a newer 510(k) K222312 (decision 2023-03-29) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 12A") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K222312
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220141 (decision 2022-04-15) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 11B") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220141
re_clearance
The FDA AI/ML device list shows a newer 510(k) K211867 (decision 2021-09-08) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 11.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211867
re_clearance
The FDA AI/ML device list shows a newer 510(k) K210645 (decision 2021-06-29) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation 10.1") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K210645
re_clearance
The FDA AI/ML device list shows a newer 510(k) K200569 (decision 2020-09-24) from RaySearch Laboratories AB (publ) for a matching device line ("RayStation") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K200569
…and 2 more.

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).