DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC— 510(k) K140445

Substantially Equivalent

Imaging Sciences International, LLC

FDA 510(k) clearance K140445 for DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC, Substantially Equivalent on 2014-04-23. Applicant: Imaging Sciences International, LLC.

Clearance details

Applicant: Imaging Sciences International, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2014-02-21
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Special
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.