AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)— 510(k) K013886

Name: FDA 510(k) clearance K013886
Creator: U.S. Food and Drug Administration
Published: 2002-05-10

Substantially Equivalent

Advanced Diagnostics, Inc.

FDA 510(k) clearance K013886 for AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM), Substantially Equivalent on 2002-05-10. Applicant: Advanced Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Diagnostics, Inc.
Product code: Code NCS
Device class: Class 2
Regulation: 21 CFR 892.1550
Advisory panel: Radiology
Date received: 2001-11-23
Decision date: 2002-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Preston, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NCS

view all

K013291 — ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)2001-11-14
K001510 — OS-2000 OPTICAL SONOGRAPHY SYSTEM2000-11-30

More clearances from Advanced Diagnostics, Inc.

view all

K023037 — MID STREAM PREGNANCY TEST2003-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.