GE Echopac

FDA 510(k) K123894 · Ge Vingmed Ultrasound AS

Substantially Equivalent

510(k) numberK123894

Submission

Device name
GE Echopac
Applicant
Ge Vingmed Ultrasound AS
Wauwatosa, WI, US
Received
December 18, 2012
Decision date
January 29, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was GE Echopac cleared by the FDA?

GE Echopac (K123894) received a 510(k) decision of Substantially Equivalent on January 29, 2013, 42 days after the submission was received.

What is the product code of K123894?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.