RayStation
K200569RaySearch Laboratories AB (publ) · cleared 2020-09-24 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software program for planning and analysis of radiation therapy. 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.”
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.”
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
- 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
- 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
- …and 1 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).