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vatech A9 (Model : PHT-30CSS)

K203797 Class II Special
Decision Date
2021-01-25
Sponsor / Applicant
VATECH Co., Ltd.

Technical Specification

510(k) Submission ID K203797
Product Code OAS
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1750
Decision Date 2021-01-25
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

vatech A9 (Model : PHT-30CSS) received FDA 510(k) clearance under submission number K203797, 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 2021-01-25.

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.