K241937
- 510(k) number
- K241937
- Device name
- Klarity SGRT System (ARSG-E1A, ARSG-E3A)
- Applicant
- Klarity Medical & Equipment (GZ) Co., Ltd. CN
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-03-18
- Date received
- 2024-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241937.pdf
Official FDA record: K241937
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.