510(k) K090321

Device

RIC CONFORMAL SOURCE, MODEL 100

Applicant

Ri Consultants, LLC

510(k) number

K090321

Product code

ONL

Decision

Substantially Equivalent (SESE)

Decision date

2009-05-27

Date received

2009-02-09

Regulation

892.5730

Classification name

Conformal Brachytherapy Source

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N