Cleared Traditional

K173456 - ViewPoint 6 (FDA 510(k) Clearance)

K173456 · Ge Medical Systems Ultrasound and Primary · Radiology device

Jan 2018

Decision

59d

Days

Class 2

Risk

K173456 is an FDA 510(k) clearance for the ViewPoint 6. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems Ultrasound and Primary (Wauwatosa, US). The FDA issued a Cleared decision on January 5, 2018, 59 days after receiving the submission on November 7, 2017.

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

Submission Details

510(k) Number	K173456 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 07, 2017
Decision Date	January 05, 2018
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF