meddevicedb.com FDA Device Reference

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

K183186 Class II Traditional
Decision Date
2019-02-08
Sponsor / Applicant
Shanghai United Imaging Healthcare Co., Ltd.

Technical Specification

510(k) Submission ID K183186
Product Code MOS
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1000
Decision Date 2019-02-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 received FDA 510(k) clearance under submission number K183186, sponsored by Shanghai United Imaging Healthcare 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 2019-02-08.

Classification & Regulation

This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.