Lung Vision System

FDA 510(k) K183593 · Bodyvision Medical , Ltd.

Substantially Equivalent

510(k) numberK183593

Submission

Device name
Lung Vision System
Applicant
Bodyvision Medical , Ltd.
Ramat Hasharon, IL
Received
December 21, 2018
Decision date
April 18, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code LLZ

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K240943LungVisionQIH · Traditional 10/01/2024SE
K172955LungVision ToolEOQ · Traditional 04/26/2018SE
K163622Lung VisionLLZ · Traditional 05/11/2017SE

Questions and answers

When was Lung Vision System cleared by the FDA?

Lung Vision System (K183593) received a 510(k) decision of Substantially Equivalent on April 18, 2019, 118 days after the submission was received.

What is the product code of K183593?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.