meddevicedb.com FDA Device Reference

Green Smart (Model: PHT-35LHS)

K162660 Class II Special
Decision Date
2016-10-20
Sponsor / Applicant
VATECH Co., Ltd.

Technical Specification

510(k) Submission ID K162660
Product Code OAS
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1750
Decision Date 2016-10-20
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Green Smart (Model: PHT-35LHS) received FDA 510(k) clearance under submission number K162660, sponsored by VATECH Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2016-10-20.

Classification & Regulation

This clearance is catalogued under FDA product code OAS and 21 CFR 892.1750, within the Radiology review panel as a Class II device.