Cyware 4H and Cysart 4H— 510(k) K221796

Substantially Equivalent

Abys Medical

FDA 510(k) clearance K221796 for Cyware 4H and Cysart 4H, Substantially Equivalent on 2022-12-30. Applicant: Abys Medical.

Clearance details

Applicant: Abys Medical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-06-21
Decision date: 2022-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Rochelle, 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.