Lung Vision System— 510(k) K183593

Substantially Equivalent

Bodyvision Medical , Ltd.

FDA 510(k) clearance K183593 for Lung Vision System, Substantially Equivalent on 2019-04-18. Applicant: Bodyvision Medical , Ltd..

Clearance details

Applicant
Bodyvision Medical , Ltd.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ramat Hasharon, IL
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.