Pure Global AI
FDA product code OEW

Tracking, Soft Tissue, Intraoperative

NeurologyClass 221 CFR 882.4560Life-sustaining
Verified
US regulatory classifications
US Product Code (FDA)
OEW
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.4560
View CFR Regulation
Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
Yes
Third party review
Not Eligible
Definition

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

Search keywords

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01Tissue tracking02Soft tissue03Intraoperative tracking04Surgical tracking05Navigation system06Image guided07Real time tracking08Surgical navigation09Tissue monitor10Surgical imaging
About this record

Tracking, Soft Tissue, Intraoperative is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.