Cleared Traditional

K183210 - Thoracic VCAR with GSI Pulmonary Perfusion (FDA 510(k) Clearance)

K183210 · GE Medical Systems SCS · Radiology device

Mar 2019

Decision

130d

Days

Class 2

Risk

K183210 is an FDA 510(k) clearance for the Thoracic VCAR with GSI Pulmonary Perfusion. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K183210 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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