ICU MEDICAL, INC. CL3969 ICU Medical

A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

Doctors Review Station - System, Image processing, Radiological

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

AR-11910SR: Grasper, Mini Straight Tip, ø2.75 mm 15° Up Curved Shaft w/SR Handle AR-13600SR: Grasper, Alligator Hook Tip, ø4.2 mm, Straight Shaft w/SR Handle AR-12500SR: Grasper, Blunt Straight Tip, ø3.4 mm Straight Shaft w/SR Handle AR-11200: Punch, Large 2.75 mm, Straight Shaft AR-12000: Punch, Standard Straight Tip, ø3.4 mm Straight Shaft AR-12240: Punch, WideBiter 15° Up Tip, ø3.4 mm Straight Shaft AR-12241: Punch, WideBiter 15° Up Tip, ø3.4 mm 15° Up Curved Shaft AR-12530: Punch, Medium Reverse Straight Tip, ø3.4 mm Straight Shaft AR-12800: Punch, Medium 45° Right Angled Tip, ø3.4 mm Straight Shaft AR-12810: Punch, Medium 45° Left Angled Tip, ø3.4 mm Straight Shaft AR-12912: Punch, WideBiter 90° Right Rotary Tip, 3.4 mm Straight Shaft AR-12913: Punch, WideBiter Rotary 90° Left Tip, ø3.4 mm Straight Shaft AR-12950: Punch, Rotary with Scoop 90° Left Tip, ø3.4 mm Straight Shaft AR-12940: Punch, Rotary with Scoop 90° Right Tip, ø3.4 mm Straight Shaft