510(k) K013886

Device

AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

Applicant

Advanced Diagnostics, Inc.

510(k) number

K013886

Product code

NCS

Decision

Substantially Equivalent (SESE)

Decision date

2002-05-10

Date received

2001-11-23

Regulation

892.1550

Classification name

System, Imaging, Holography, Acoustic

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N