510(k) K003438
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2001
- Date Received
- November 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type