510(k) K042368
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 2004
- Date Received
- August 31, 2004
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type