RayStation

K190387

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

FDA 510(k) summary for RayStation (K190387)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
0
Product code
MUJ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“RayStation 8.1 is a radiation therapy treatment planning system, i.e. a software program for planning, management and analysis of radiation therapy treatment.”
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
PCCPNo
Cybersecurity addressedNo

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

25
recalls in product code, 24mo
19
MAUDE reports in code, 12mo
-44%
vs code's own 3-yr baseline
8
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.

Recalls attributed to this device

  • Recall record explicitly lists K190387 · RAYSEARCH LABORATORIES AB · initiated 2025-08-08 · Open, Classified

    DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

    recall event 97400 (openFDA)

  • Recalling firm matches this device's applicant (RAYSEARCH LABORATORIES AB) — same firm and product code, not necessarily this device · initiated 2026-05-20

    Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

    recall event 99141 (openFDA)

  • Recalling firm matches this device's applicant (RAYSEARCH LABORATORIES AB) — same firm and product code, not necessarily this device · initiated 2026-05-20

    Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

    recall event 99141 (openFDA)

  • Recalling firm matches this device's applicant (RAYSEARCH LABORATORIES AB) — same firm and product code, not necessarily this device · initiated 2025-11-28

    Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

    recall event 98117 (openFDA)

  • Recalling firm matches this device's applicant (RAYSEARCH LABORATORIES AB) — same firm and product code, not necessarily this device · initiated 2025-11-28

    Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

    recall event 98117 (openFDA)

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code MUJ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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ART-Plan+ (v3.1.0)

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cleared 2025-09-04

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

K250440

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cleared 2025-06-17

Oncospace

K242748

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cleared 2025-04-11

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

K240398

RaySearch Laboratories AB (PUBL)

cleared 2025-04-04

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K190387