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.5)

“Monaco is programmed using C, C++ and C# computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.”

Algorithmmachine-learning based models to automatically segment MR image sets

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)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“IEC 81001-5-1”

Validation studies (1)

Standalone

sample size not stated

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

standards: ISO 13485, ISO 14971, IEC 62304, IEC 62083, IEC 82304-1, IEC 61217, IEC 62366-1, IEC 81001-5-1, ISO 15223-1, ISO 20417

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

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). 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).