syngo.via RT Image Suite
K211379Siemens Medical Solutions USA Inc. · cleared 2021-07-30 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject device with the current software version SOMARIS/8 VB60 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 subject device syngo.via RT Image Suite VB60 includes an AI-based algorithm for the creation of synthetic CT images from MR images to be used in the preparation of radiation therapy treatment planning. The algorithm for brain and pelvis synthetic CTs has been changed from Atlas based to a deep-learning algorithm.”
Validation studies (1)
Bench
sample size not stated
endpoints: geometric accuracy; HU accuracy
standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2015-06 (Edition 1.1), 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 (2 observations)
source quote (p.8)
“The subject device algorithm demonstrated very good geometric accuracy with average deviations in the body outline smaller than 1 mm, which is below the voxel resolution and therefore not clinically relevant.”
source quote (p.8)
“The HU accuracy of the subject device algorithm was well within 50 HU (200 HU) for soft (bone) tissue.”
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
- 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).