Cleared Traditional

K182750 - 4D View (FDA 510(k) Clearance)

K182750 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device

Dec 2018

Decision

84d

Days

Class 2

Risk

K182750 is an FDA 510(k) clearance for the 4D View. 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 December 21, 2018, 84 days after receiving the submission on September 28, 2018.

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

Submission Details

510(k) Number	K182750 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2018
Decision Date	December 21, 2018
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF