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U.S. Department of Health and Human Services

Product Classification
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Device tracking, soft tissue, intraoperative
Regulation Description Stereotaxic instrument.
Definition For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Physical State a PC with LCD monitor for displaying images, tracked laser range scanner, tracked fixed reference emitter, tracked localization probe with infrared emitting dioodes, and three lens active-based optical position sensor
Technical Method the device uses optical, infrared light tracking systems for localizing surgical tools and a camera for spatial reconstruction of tool alignment and position
Target Area soft tissue
Regulation Medical Specialty Neurology
Review Panel General & Plastic Surgery
Product CodeOEW
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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