Last synced on 24 May 2024 at 11:04 pm

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

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).

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

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).