Monaco RTP System (6.3)

K252002

Elekta Solutions AB · cleared 2026-02-19 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“The Segmentation Component utilizes machine-learning based models to automatically segment MR image sets introduced in subject device.”
Algorithmmachine-learning based models for segmentation
source quote (p.7)
“The Segmentation Component utilizes machine-learning based models to automatically segment MR image sets introduced in subject device.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=2,641 images

endpoints: Average Hausdorff Distance (AVD); Dice Similarity Coefficient (DICE); AUC; Absolute Volume Difference (AVD)

Reported performance (2 observations)

aurocas written: “auc”0.7
source quote (p.9)
“A DICE or AUC value of 0.7 is also taken to represent a value of interest that might indicate model performance with respect to a structure or set of structures, however the DICE and AUC results were not explicitly used as the pass/fail metric.”
diceas written: “Dice Similarity Coefficient (DICE) confidence value”0.7
source quote (p.9)
“the patterns of failure for any structure that did not meet the Dice Similarity Coefficient (DICE) confidence value of interest of 0.7 were investigated and any findings were included as "Limitations".”

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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
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); 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252002