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MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM

K002840 Class II Traditional
Decision Date
2000-11-17
Sponsor / Applicant
The Phantom Laboratory, Inc.

Technical Specification

510(k) Submission ID K002840
Product Code IZI
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1600
Decision Date 2000-11-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM received FDA 510(k) clearance under submission number K002840, sponsored by The Phantom Laboratory, 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 2000-11-17.

Classification & Regulation

This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.