Cleared Special

GE ECHOPAC

K072952 · General Electric Co. · Radiology
Nov 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K072952 is an FDA 510(k) clearance for the GE ECHOPAC, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on November 16, 2007, 29 days after receiving the submission on October 18, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K072952 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2007
Decision Date November 16, 2007
Days to Decision 29 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