510(k) K240385
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2024
- Date Received
- February 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type