510(k) K241980
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2025
- Date Received
- July 5, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type