Cleared Traditional

K183593 - Lung Vision System (FDA 510(k) Clearance)

K183593 · Bodyvision Medical , Ltd. · Radiology device

Apr 2019

Decision

118d

Days

Class 2

Risk

K183593 is an FDA 510(k) clearance for the Lung Vision System. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Bodyvision Medical , Ltd. (Ramat Hasharon, IL). The FDA issued a Cleared decision on April 18, 2019, 118 days after receiving the submission on December 21, 2018.

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

Submission Details

510(k) Number	K183593 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2018
Decision Date	April 18, 2019
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF