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DIGITAL ULTRASOUND SCANNER

K100079 Class II Traditional
Decision Date
2010-03-01
Sponsor / Applicant
Shenzhen Well.D Medical Electronics Co., Ltd.

Technical Specification

510(k) Submission ID K100079
Product Code IYO
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1560
Decision Date 2010-03-01
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

DIGITAL ULTRASOUND SCANNER received FDA 510(k) clearance under submission number K100079, sponsored by Shenzhen Well.D Medical Electronics 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 2010-03-01.

Classification & Regulation

This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.