510(k) K010571
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2001
- Date Received
- February 26, 2001
- Clearance Type
- Special
- 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