Pathfinder Therapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Pathfinder Therapeutics, Inc. makes
Pathfinder Therapeutics, Inc. manufactures ultrasound-based imaging systems for liver surgery, including the LINASYS and PLANISIGHT LINASYS platforms. These devices also include the LINASYS Image-Guided Liver Surgery System, which integrates real-time imaging for surgical guidance. The company produces passive tracking systems like the EXPLORER LIVER, designed for intraoperative navigation.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to FDA oversight. No other regulatory registries or jurisdictions are specified.
Catalogue
Linasys Ref K071063
Regimes: 510(k) Registry: 510(k)Planisight Linasys Ref K082228
Regimes: 510(k) Registry: 510(k)Linasys Image-Guided Liver Surgery System Ref K093494
Regimes: 510(k) Registry: 510(k)Explorer Liver (Passive Tracking) Ref K101979
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pathfinder Therapeutics, Inc. have in the registry?
The registry currently lists 4 devices for Pathfinder Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pathfinder Therapeutics, Inc.'s devices?
Among its 4 most recently registered devices, Pathfinder Therapeutics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Pathfinder Therapeutics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pathfinder Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pathfinder Therapeutics, Inc. in the registry?
The most recently registered devices listed for Pathfinder Therapeutics, Inc. include LINASYS, PLANISIGHT LINASYS, LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM and EXPLORER LIVER (PASSIVE TRACKING).