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DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16

K080553 Class II Traditional
Decision Date
2008-04-16
Sponsor / Applicant
Vieworks Co., Ltd.

Technical Specification

510(k) Submission ID K080553
Product Code KPR
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1680
Decision Date 2008-04-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 received FDA 510(k) clearance under submission number K080553, sponsored by Vieworks Co., 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 2008-04-16.

Classification & Regulation

This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.