ASCEND Image Viewer— 510(k) K192372

Substantially Equivalent

Ascend Hit

FDA 510(k) clearance K192372 for ASCEND Image Viewer, Substantially Equivalent on 2020-02-14. Applicant: Ascend Hit.

Clearance details

Applicant: Ascend Hit
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-08-30
Decision date: 2020-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, 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.