Cleared Traditional

Thoracic VCAR with GSI Pulmonary Perfusion

K183210 · GE Medical Systems SCS · Radiology

Mar 2019

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K183210 is an FDA 510(k) clearance for the Thoracic VCAR with GSI Pulmonary Perfusion, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on March 29, 2019, 130 days after receiving the submission on November 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K183210 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2018
Decision Date	March 29, 2019
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF