DEXIS Webview— 510(k) K151941

Substantially Equivalent

Imaging Sciences International /Gendex/Dexis

FDA 510(k) clearance K151941 for DEXIS Webview, Substantially Equivalent on 2015-10-07. Applicant: Imaging Sciences International /Gendex/Dexis.

Clearance details

Applicant: Imaging Sciences International /Gendex/Dexis
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-07-14
Decision date: 2015-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.