syngo.via RT Image Suite

K232799

Siemens Medical Solutions USA, Inc. · cleared 2024-04-26 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“The subject device with the current software version SOMARIS/8 VB80 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy.”

AlgorithmDL-based autocontouring algorithm

source quote (p.8)

“There are no changes on the underlying DL-based autocontouring algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=413 patients

endpoints: geometric overlap with the ground truth (Dice coefficient)

standards: ANSI AAMI IEC 62304, NEMA PS 3.1 - 3.20 2022d, ISO 14971, IEC 62366-1, ISO 15223-1, ISO 20417

Reported performance (1 observation)

diceas written: “Dice coefficient”stated without value

source quote (p.9)

“The testing ensures the quantitative performance of the resulting segmentations by comparing them to the manually annotated ground truth based on the commonly used overlap metric Dice coefficient. All tests passed the defined acceptance criteria on the geometric overlap with the ground truth.”

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).