FlexView Diagnostic (v1.1.20)— 510(k) K233226

Substantially Equivalent

Radical Imaging, LLC

FDA 510(k) clearance K233226 for FlexView Diagnostic (v1.1.20), Substantially Equivalent on 2024-01-17. Applicant: Radical Imaging, LLC.

Clearance details

Applicant: Radical Imaging, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-09-28
Decision date: 2024-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stow, MA, 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.