510(k) K260236
K260236 is an FDA 510(k) premarket notification submitted by GEMSS HEALTHCARE CO., LTD. for the device "XLITE". The FDA issued a decision of Substantially Equivalent on Aug 3, 2026. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. GEMSS HEALTHCARE CO., LTD. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2026
- Date Received
- Jan 26, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type
- 510(k)