510(k) K241440
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2024
- Date Received
- May 21, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type