OEW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tracking, Soft Tissue, Intraoperative
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Flags
- Life-sustaining
- FDA definition
- For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAS-One Liver (K143024) | Cascination AG | 2015-04-28 |
| EXPLORER LIVER (PASSIVE TRACKING) (K101979) | Pathfinder Therapeutics, Inc. | 2011-02-09 |
| LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM (K093494) | Pathfinder Therapeutics, Inc. | 2010-03-30 |
| LINASYS (K071063) | Pathfinder Therapeutics, Inc. | 2007-12-20 |
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Every clearance here is in the API, with alerts when new ones post.