# Tracking, Soft Tissue, Intraoperative
> **Product code: OEW** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
## Classification
- **FDA Product Code:** OEW
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.4560
- **Review panel:** SU
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OEW)
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