Syngo.via RT Image Suite
K201444Siemens Medical Solutions USA, Inc. · cleared 2020-08-13 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject device with the current software version SOMARIS/8 VB50 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.”
source quote (p.8)
“The organ segmentation consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image-to-Image Network performing the actual segmentation step. This technology was introduced in the predicate device. In the subject device, the same technology is extended to additional organs. The fundamental algorithm did not change. As described, we're using the same technology (or in other words the same algorithm) but the organ portfolio has been extended. The AI or deep learning-based algorithm has been initially cleared with the predicate device RT Image Suite SOMARIS/8 VB40 (K192065).”
source quote (p.8)
“The fundamental algorithm did not change.”
Validation studies (1)
Retrospective clinical
n=112 patients
endpoints: detection rates; segmentation quality assessed by overlap measure DICE coefficient; non-inferior or superior performance for all organ segmentations
standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2006 (1st Edition), Medical devices – Application of risk management to medical devices; 14971 Second Edition 2007-03-01, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015
Reported performance (1 observation)
source quote (p.8)
“Newly added organs in the subject device were detected at a rate of 100%.”
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
- 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).