MVision AI Segmentation
K212915MVision AI · cleared 2022-05-03 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“MVision AI Segmentation is a software only medical device which can be used to accelerate region of interest (ROI) delineation in radiotherapy treatment planning by creating automatic segmentation templates on CT images for these ROIs.”
source quote (p.4)
“The segmentations are produced by pre-trained, locked, and static models that are based on deep artificial neural networks.”
source quote (p.4)
“The segmentations are produced by pre-trained, locked, and static models that are based on deep artificial neural networks.”
source quote (p.8)
“Software verification and validation, performance evaluation for machine learning based algorithms, and implemented Cybersecurity control measures and tests establish that the subject medical device is safe, secure and effective for its user needs and defined intended use.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: reducing the upfront effort and time on typical contouring; producing usable contours (ROIs) as a starting point that will save clinicians' time
standards: FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”, CFR 21 Part 820, DICOM standard
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
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).