Clearance Summary
Ventripoint Medical System Plus (VMS+) 4.0 received FDA 510(k) clearance under submission number K241222, sponsored by Ventripoint Diagnostics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-02-26.
- Submission: K241222
- Applicant / Sponsor: Ventripoint Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2025-02-26
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.