510(k) K230800
K230800 is an FDA 510(k) premarket notification submitted by GEMSS HEALTHCARE CO., LTD. for the device "XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50". The FDA issued a decision of Substantially Equivalent on Nov 2, 2023. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. GEMSS HEALTHCARE CO., LTD. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 2, 2023
- Date Received
- Mar 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)