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BONE DENSITY CT PHANTOM

K852528 Class I Traditional
Decision Date
1985-09-26
Sponsor / Applicant
Computerized Imaging Reference Systems, Inc.

Technical Specification

510(k) Submission ID K852528
Product Code IXG
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1950
Decision Date 1985-09-26
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BONE DENSITY CT PHANTOM received FDA 510(k) clearance under submission number K852528, sponsored by Computerized Imaging Reference Systems, 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 1985-09-26.

Classification & Regulation

This clearance is catalogued under FDA product code IXG and 21 CFR 892.1950, within the Radiology review panel as a Class I device.