RayStation 10.1

K210645

RaySearch Laboratories AB (publ) · cleared 2021-06-29 · product code MUJ · Radiology

FDA 510(k) summary for RayStation 10.1 (K210645)

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
5
Cited predicates
3
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.3)
“RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.”
Algorithmdose and optimization engines, robust planning
source quote (p.4)
“It has a modern user interface and is equipped with fast and accurate dose and optimization engines. The robustness of a plan can be evaluated by taking uncertainties such as CT inaccuracy and setup errors into account. Robustness handling in RayStation 10.1 has been expanded to also take the uncertainty of the patient's internal organ motion into account. Based on user defined criteria the system computes a set of scenario doses for evaluation.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Bench

sample size not stated

endpoints: accuracy in clinically relevant settings according to specification

standards: TG43

Bench

sample size not stated

endpoints: appropriate for supporting medical oncology planning workflows

Bench

sample size not stated

endpoints: accuracy in clinically relevant settings according to specification

Bench

sample size not stated

endpoints: validated according to specification

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
7
drift signals on this device
  • predicate_cohort_contagion

    K210645 shares predicate K181145 with K192377 (Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon), whose product code IYE recorded 13 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K181145 sibling:K192377

  • 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

  • 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.

Recalls attributed to this device

  • Recall record explicitly lists K210645 · RAYSEARCH LABORATORIES AB · initiated 2025-11-28 · Open, Classified

    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 record explicitly lists K210645 · 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)

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.

RadOncAI

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Monaco RTP System (6.3)

K252002

Elekta Solutions AB

cleared 2026-02-19

ART-Plan+ (v3.1.0)

K253091

Therapanacea Sas

cleared 2025-12-23

Dose+ (1.0)

K250064

Mvision AI Oy

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

Brainlab AG

cleared 2025-06-17

Oncospace

K242748

Oncospace, Inc.

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/K210645