Syngo.Via RT Image Suite
K192065Siemens Medical Solutions USA, Inc. · cleared 2019-09-18 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject device with the current software version SOMARIS/8 VB40 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 and response assessment in radiation therapy.”
source quote (p.6)
“A new deep learning-based approach that uses an adversarial network has been implemented”
Validation studies (2)
Bench
sample size not stated
endpoints: test the functionality; test the ability of the included features
Retrospective clinical
n=32 other
endpoints: detection rate; segmentation quality; Average Symmetric Surface Distance (ASSD); overlap measure DICE coefficient
Reported performance (2 observations)
source quote (p.7)
“The detection rate of the subject device improved for the OAR Brain, Liver, Kidney Left, and Kidney Right compared to the predicate device, achieving 100% for all evaluated organs.”
source quote (p.7)
“The mean DICE coefficient ranged between 0.85 (for Prostate and Rectum) and 0.97 (for Heart).”
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K220783 (decision 2022-09-07) 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:K220783
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K211379 (decision 2021-07-30) 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:K211379
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K201444 (decision 2020-08-13) 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:K201444
- 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).