syngo.via RT Image Suite

K220783

Siemens Medical Solutions USA Inc. · cleared 2022-09-07 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The subject device with the current software version SOMARIS/8 VB70 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.”

AlgorithmAI-based component, namely deep-learning based autosegmentation of lung lobes

source quote (p.8)

“The algorithm contains an AI-based component, namely deep-learning based autosegmentation of lung lobes.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=18 patients

endpoints: geometric overlap with the annotated ground truth as measured by DICE compared to the predicate device

Retrospective clinical

n=74 patients

endpoints: distribution of lung ventilation; correlation with vital capacity as measured by PFT (spirometry)

Reported performance (1 observation)

diceas written: “mean DICE”0.92

source quote (p.8)

“A mean DICE of 0.92 was achieved for the lung lobes across the test set.”

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K232799 (decision 2024-04-26) from Siemens Medical Solutions USA, Inc. for a matching device line ("syngo.via RT Image Suite") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232799
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).