Cleared Traditional

K162743 - ViewPoint 6 (FDA 510(k) Clearance)

K162743 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device

Nov 2016

Decision

53d

Days

Class 2

Risk

K162743 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 Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on November 22, 2016, 53 days after receiving the submission on September 30, 2016.

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

Submission Details

510(k) Number	K162743 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2016
Decision Date	November 22, 2016
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF