Tracking, Soft Tissue, Intraoperative
The Intraoperative Soft Tissue Tracking System (product code OEW) is a neurological image-guidance device used during open liver surgical procedures where image-guidance may be appropriate and the patient can tolerate apneic periods under general anesthesia, enabling real-time tracking of soft tissue structures to assist surgical navigation. This device is FDA Class 2 under regulation 882.4560 in the Neurology specialty, requiring 510(k) clearance, and is notably flagged as life-sustaining/life-supporting given its use in critical surgical procedures. It carries no implant flag.
Research product code OEW in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OEW
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143024 | CAS-One Liver | Apr 28, 2015 | Substantially Equivalent | Cascination AG |
| K101979 | EXPLORER LIVER (PASSIVE TRACKING) | Feb 09, 2011 | Substantially Equivalent | Pathfinder Therapeutics, Inc. |
| K093494 | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Mar 30, 2010 | Substantially Equivalent | Pathfinder Therapeutics, Inc. |
| K071063 | LINASYS | Dec 20, 2007 | Substantially Equivalent | Pathfinder Therapeutics, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.