GE EchoPAC

FDA 510(k) K150085 · Ge Vingmed Ultrasound AS

Substantially Equivalent

510(k) numberK150085

Submission

Device name
GE EchoPAC
Applicant
Ge Vingmed Ultrasound AS
Horten, NO
Received
January 15, 2015
Decision date
March 2, 2015
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 (K150085) received a 510(k) decision of Substantially Equivalent on March 2, 2015, 46 days after the submission was received.

What is the product code of K150085?

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