Cleared Traditional

K150193 - Customer Remote Console (CRC) (FDA 510(k) Clearance)

K150193 · Ge Medical Systems, LLC · Radiology device

Mar 2015

Decision

55d

Days

Class 2

Risk

K150193 is an FDA 510(k) clearance for the Customer Remote Console (CRC). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on March 24, 2015, 55 days after receiving the submission on January 28, 2015.

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

Submission Details

510(k) Number	K150193 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 2015
Decision Date	March 24, 2015
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF