Syngo.via RT Image Suite

K201444

Siemens Medical Solutions USA, Inc. · cleared 2020-08-13 · 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 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.”
AlgorithmDeep Image-to-Image Network, AI or deep learning-based algorithm
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). Automatic Contouring in the head/neck region, which was previously atlas-based, is now done with deep learning. The atlas method is entirely removed from this version.”
Adaptive (vs locked)No
source quote (p.8)
“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.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=112 patients

endpoints: detection rates; segmentation quality (DICE coefficient)

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

Bench

sample size not stated

endpoints: continued conformance with special controls; ability of the included features; performs as intended

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 (2 observations)

detection_rateas written: “Detection Rate (newly added organs)”100
source quote (p.8)
“Newly added organs in the subject device were detected at a rate of 100%.”
diceas written: “DICE coefficient”stated without value
source quote (p.8)
“The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the overlap measure DICE coefficient. The quantitative evaluation demonstrates non-inferior or superior performance for all organ segmentations in the subject device compared to the predicate device.”

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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
5
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

  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2022-03-07

    Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

    recall event 89915 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2021-08-16

    Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS).

    recall event 88588 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2020-08-19

    Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location

    recall event 86185 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2020-06-24

    If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.

    recall event 86000 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K201444