meddevicedb.com FDA Device Reference

FERRISCAN R2-MRI ANALYSIS SYSTEM

DEN130012 Class II Direct
Decision Date
2013-01-23
Sponsor / Applicant
Resonance Health Analysis Services Pty, Ltd.

Technical Specification

510(k) Submission ID DEN130012
Product Code PCS
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1001
Decision Date 2013-01-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

FERRISCAN R2-MRI ANALYSIS SYSTEM received FDA 510(k) clearance under submission number DEN130012, sponsored by Resonance Health Analysis Services Pty, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-01-23.

Classification & Regulation

This clearance is catalogued under FDA product code PCS and 21 CFR 892.1001, within the Radiology review panel as a Class II device.