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Ventripoint Medical System Plus (VMS+)

K173810 Class II Traditional
Decision Date
2018-05-14
Sponsor / Applicant
Ventripoint Diagnostics , Ltd.

Technical Specification

510(k) Submission ID K173810
Product Code IYN
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1550
Decision Date 2018-05-14
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Ventripoint Medical System Plus (VMS+) received FDA 510(k) clearance under submission number K173810, 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 2018-05-14.

Classification & Regulation

This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.