The following data is part of a premarket notification filed by Pathfinder Therapeutics, Inc. with the FDA for Linasys Image-guided Liver Surgery System.
| Device ID | K093494 |
| 510k Number | K093494 |
| Device Name: | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM |
| Classification | Tracking, Soft Tissue, Intraoperative |
| Applicant | PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Contact | Craig Henderson |
| Correspondent | Craig Henderson PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Product Code | OEW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-10 |
| Decision Date | 2010-03-30 |
| Summary: | summary |