meddevicedb.com FDA Device Reference

CTXA HIP EXTENDED REFERENCE DATA

K030330 Class II Traditional
Decision Date
2003-06-20
Sponsor / Applicant
Mindways Software, Inc.

Technical Specification

510(k) Submission ID K030330
Product Code KGI
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1170
Decision Date 2003-06-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CTXA HIP EXTENDED REFERENCE DATA received FDA 510(k) clearance under submission number K030330, sponsored by Mindways Software, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-06-20.

Classification & Regulation

This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.