ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)— 510(k) K013291

Name: FDA 510(k) clearance K013291
Creator: U.S. Food and Drug Administration
Published: 2001-11-14

Substantially Equivalent

Advanced Diagnostics, Inc.

FDA 510(k) clearance K013291 for ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM), Substantially Equivalent on 2001-11-14. 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: 2001-10-02
Decision date: 2001-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Preston, WA, US

Download summary PDF View on FDA.gov ↗

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