meddevicedb.com FDA Device Reference

JiveX (Model Number / Release: 5.3)

K212321 Class II Traditional
Decision Date
2021-09-23
Sponsor / Applicant
Visus Health IT GmbH

Technical Specification

510(k) Submission ID K212321
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2021-09-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

JiveX (Model Number / Release: 5.3) received FDA 510(k) clearance under submission number K212321, sponsored by Visus Health IT GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-09-23.

Classification & Regulation

This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.