RayCare 2.3

K191384

RaySearch Laboratories AB (publ) · cleared 2019-07-08 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesimd

source quote (p.4)

“RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions.”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.5)

“Authentication, authorization and audit logging”

Validation studies (1)

Bench

sample size not stated

standards: ISO 14971, IEC 61217, IEC 62304, IEC 62366

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).