MYRIAN 1.4— 510(k) K091001

Substantially Equivalent

Intrasense

FDA 510(k) clearance K091001 for MYRIAN 1.4, Substantially Equivalent on 2009-06-29. Applicant: Intrasense.

Clearance details

Applicant: Intrasense
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-04-08
Decision date: 2009-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier, FR

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.