MVision Contour+ AI
MVision AI · mvision.ai ↗
AI auto-segmentation for radiotherapy.
AI status
AI product On FDA AI-enabled device list (K241490) · source
Compliance profile
| Field | Status | Detail | Source | Checked |
|---|---|---|---|---|
| FDA | Verified | 510(k) cleared · K241490 | accessdata.fda.gov | 2026-10-14 |
| HIPAA | Vendor-stated | Vendor states HIPAA compliance support | mvision.ai | 2026-10-14 |
| BAA | Vendor-stated | Vendor mentions a BAA | mvision.ai | 2026-10-14 |
| SOC 2 | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| HITRUST | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| Epic integration | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
Vendor-stated means the claim appears on the vendor’s site; we have not audited it. Unverified means we found no source, which is not a negative finding. Vendors can request a correction.
FDA records
From the FDA AI-enabled medical devices list. Wording follows FDA: 510(k) “cleared”, De Novo “granted”. Clearance applies to the specific indication in the FDA record.
| Number | Device (as listed) | Pathway | Decision date | Panel |
|---|---|---|---|---|
| K241490 | Contour+ (MVision AI Segmentation) | 510(k) cleared | 10/18/2024 | Radiology |
| K212915 | MVision AI Segmentation | 510(k) cleared | 05/03/2022 | Radiology |
Alternatives
MIM Contour ProtégéAIRadformation AutoContourTherapanacea ART-PlanSiemens AI-Rad Companion Organs RT
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