Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Tracking, Soft Tissue, Intraoperative
- Page Type
- Product Code
- 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 and Plastic Surgery
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 882.4560
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- Yes
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 882.4560 Stereotaxic instrument
§ 882.4560 Stereotaxic instrument.
(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
(b) Classification. Class II (performance standards).