AXIR-CX— 510(k) K213520

Substantially Equivalent

Radisen Co., Ltd.

FDA 510(k) clearance K213520 for AXIR-CX, Substantially Equivalent on 2022-08-19. Applicant: Radisen Co., Ltd..

Clearance details

Applicant: Radisen Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2021-11-03
Decision date: 2022-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

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.