510(k) K093494
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2010
- Date Received
- November 10, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tracking, Soft Tissue, Intraoperative
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- SU
- Submission Type
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.