Klarity SGRT System (ARSG-E1A, ARSG-E3A)— 510(k) K241937

Substantially Equivalent

Klarity Medical & Equipment (GZ) Co., Ltd.

FDA 510(k) clearance K241937 for Klarity SGRT System (ARSG-E1A, ARSG-E3A), Substantially Equivalent on 2025-03-18. Applicant: Klarity Medical & Equipment (GZ) Co., Ltd..

Clearance details

Applicant: Klarity Medical & Equipment (GZ) Co., Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2024-07-02
Decision date: 2025-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.