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.”

Algorithm3D UNet/DI2IN-based DL models

source quote (p.19)

“3D UNet/DI2IN-based DL models.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

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 (1)

Standalone

n=760 patients

endpoints: DICE coefficient; ASSD; Hausdorff Distance; false-positive rate per case; sensitivity; HU accuracy; geometric fidelity

standards: ISO 14971:2019, ISO 15223-1:2021, ISO 20417:2021, IEC 62304:2006 + A1:2016, IEC 623661:2015+A1:2020, IEC 82304-1:2016, IEC 61217:2011, IEC 62083:2009, UL ANSI 2900-1:2017, UL ANSI 2900-21:2017, IEC 81001-5-1:2021

Reported performance (2 observations)

sensitivity92.5CI 85.8

source quote (p.38)

“Mean 92.5 ... Lower 95th % Confidence Interval 85.8”

diceas written: “DICE (Brain metastases)”0.74CI 0.72

source quote (p.38)

“Mean 0.74 ... Lower 95th % Confidence Interval 0.72”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-50%

vs code's own 3-yr baseline

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). 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).