syngo.via RT Image Suite

K232799

Siemens Medical Solutions USA, Inc. · cleared 2024-04-26 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).”
AlgorithmDL-based autocontouring algorithm
source quote (p.8)
“The existing, cleared Advanced Contouring feature has been extended by additional anatomical structures. There are no changes on the underlying DL-based autocontouring algorithm.”
Adaptive (vs locked)No
source quote (p.8)
“There are no changes on the underlying DL-based autocontouring algorithm.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: ANSI AAMI IEC 62304, NEMA PS 3.1 - 3.20 2022d, ISO 14971, IEC 62366-1, ISO 15223-1, ISO 20417

Retrospective clinical

n=413 patients

endpoints: geometric overlap (Dice coefficient)

standards: ANSI AAMI IEC 62304, NEMA PS 3.1 - 3.20 2022d, ISO 14971, IEC 62366-1, ISO 15223-1, ISO 20417

Reported performance (1 observation)

diceas written: “Dice coefficient”stated without value
source quote (p.9)
“The testing ensures the quantitative performance of the resulting segmentations by comparing them to the manually annotated ground truth based on the commonly used overlap metric Dice coefficient.”

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
2
drift signals on this device
  • 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/K232799