Libby IAAA v1.0— 510(k) K210931

Substantially Equivalent

Dyad Medical, Inc.

FDA 510(k) clearance K210931 for Libby IAAA v1.0, Substantially Equivalent on 2021-12-17. Applicant: Dyad Medical, Inc..

Clearance details

Applicant: Dyad Medical, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-03-29
Decision date: 2021-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, 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.