EXINI— 510(k) K122205

Substantially Equivalent

Exini Diagnostics AB

FDA 510(k) clearance K122205 for EXINI, Substantially Equivalent on 2012-08-15. Applicant: Exini Diagnostics AB.

Clearance details

Applicant: Exini Diagnostics AB
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-07-25
Decision date: 2012-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, 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.