510(k) K251645
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP by
Canon Medical Systems Corporation
— Product Code JAK
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2025
- Date Received
- May 29, 2025
- Clearance Type
- Traditional
- 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