LungVision Tool— 510(k) K172955

Substantially Equivalent

Bodyvision Medical , Ltd.

FDA 510(k) clearance K172955 for LungVision Tool, Substantially Equivalent on 2018-04-26. Applicant: Bodyvision Medical , Ltd..

Clearance details

Applicant: Bodyvision Medical , Ltd.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2017-09-26
Decision date: 2018-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Hasharon, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.