510(k) K241937
K241937 is an FDA 510(k) premarket notification submitted by Klarity Medical & Equipment (GZ) Co., Ltd. for the device "Klarity SGRT System (ARSG-E1A, ARSG-E3A)". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Klarity Medical & Equipment (GZ) Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2025
- Date Received
- July 2, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type