syngo.via RT Image Suite VC10

K252304

Varian Medical Systems, Inc. · cleared 2026-03-18 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“syngo.via RT Image Suite VC10 is an image analysis and radiation therapy preparation software that provides multimodality image viewing, registration, segmentation, synthetic CT generation, and patient-marking workflows.”
AlgorithmAI-based deep learning
source quote (p.7)
“The AI-based MR autocontouring functionality has been introduced to include segmentation of previously diagnosed brain metastases, in addition to MR-based segmentation of brain OARs and male pelvis OARs. syngo.via RT Image Suite VC10 includes 29 new organs and structures for deep-learning-based CT autocontouring. VC10 replaces the prior 2D synthetic CT algorithm with an enhanced 3D Deep learning model, improving accuracy and robustness for brain and pelvis.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.20)
“Cybersecurity and Interoperability requirements were assessed per FDA guidance's “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, “Postmarket Management of Cybersecurity in Medical Devices”, “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices”.”

Validation studies (7)

Retrospective clinical

n=469 patients

endpoints: DICE coefficient; ASSD

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=30 patients

endpoints: DICE; Hausdorff Distance; false-positive rate per case; sensitivity

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=81 patients

endpoints: DICE; ASSD

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=153 patients

endpoints: DICE; ASSD

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=51 patients

endpoints: HU accuracy; geometric fidelity

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=10 patients

endpoints: Isocenter placed within defined anatomical structure; percentage of cases which need corrections

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Retrospective clinical

n=10 patients

endpoints: Isocenter placed within defined anatomical structure

standards: IEC 62304, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, IEC 82304-1, IEC 61217, IEC 62083, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Reported performance (5 observations)

sensitivity92.5CI 85.8
source quote (p.38)
“Brain metastases (parenchymal) 60 0.74 0.17 0.72 92.5 3.4 85.8”
diceas written: “DICE (CT auto-contouring) - Body”0.99CI 0.99
source quote (p.24)
“Body 46 0.99 0.003 0.99”
diceas written: “Dice Coefficient (MR Brain Metastasis)”0.74
source quote (p.19)
“Dice Coefficient 0.74”
diceas written: “DICE (MR Brain OAR) - Brainstem”0.93CI 0.92
source quote (p.41)
“Brainstem 81 0.93 0.02 0.92 0.54 0.15 0.57”
diceas written: “DICE (MR Pelvis OAR) - Body (T1 Pelvis)”0.98CI 0.98
source quote (p.42)
“Body 55 0.98 0.01 0.98 1.4 1.56 1.82”

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

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/K252304