The following data is part of a premarket notification filed by Pathfinder Therapeutics, Inc. with the FDA for Planisight Linasys.
| Device ID | K082228 |
| 510k Number | K082228 |
| Device Name: | PLANISIGHT LINASYS |
| Classification | System, Image Processing, Radiological |
| Applicant | PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Contact | James D Stefansic |
| Correspondent | James D Stefansic PATHFINDER THERAPEUTICS, INC. 2969 ARMORY DRIVE SUITE 100A Nashville, TN 37204 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-09-22 |
| Summary: | summary |