Cleared Special

K063846 - EIGEN DSA 2000
(FDA 510(k) Clearance)

K063846 · Eigen · Radiology
Jan 2007
Decision
30d
Days
Class 2
Risk

K063846 is an FDA 510(k) clearance for the EIGEN DSA 2000. This device is classified as a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ).

Submitted by Eigen (San Diego, US). The FDA issued a Cleared decision on January 26, 2007, 30 days after receiving the submission on December 27, 2006.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K063846 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2006
Decision Date January 26, 2007
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050