ABBOTT LABORATORIES 08P6306 Alinity

GE OEC Elite CFD 31cm Flat Detector Super C-Arm - VAS 15 Software. GE OEC Elite CFD C-Arm 31 cm Flat Detector w/ Bumper VAS 15 Vascular Software, SUPER C Motorized C Refurbished, Calibrated, Ready for Use 31 cm CMOS Flat Detector (CFD) - CMOS - Complementary metal-oxide semiconductor detector - DQE(0): 72% - Active amplification inside pixel for ultra-fast electron mobility - Active Matrix: 1548x1524 pixels - Pixel Pitch: 190.0 um - Nominal resolution (at display): 31 cm: 2.7 lp/mm; 21 cm: 2.8 lp/mm; 15 cm: 2.9 lp/mm - Quad-mode magnification: Live Zoom fluidly from 1 to 4X with no change in dose; Fixed try-mode Mag settings: 31cm/21cm/15cm Workstation Display - 13.6 in Live and Reference Image displayed size - 1 to 1 detail imaging chain from CMOS detector to 4K display resolution - Squircle shaped image retains 100% of image when rotated and no cropped or changed view. - 4K, 32" Ultra high definition (UHD) Color Display - Monitor displays two split screens for equivalent view of two 20in displays - 3840x2160 display resolution - 600 cd/m2 maximum brightness - Touchscreen interface with anti-reflection, anti-fingerprint - Easily position monitor to surgical line of sight with display mount on an articulating arm with five movements What's Included: GE OEC Elite CFD C-Arm, Super C; (REF OEC Elite) Qty: 1 GE Beam Limiting Device; (REF 5455288-03) Qty: 1 GE Laser Aiming Device; (REF 5440087) Qty: 1 GE Image Receptor; (REF 5457729-02) Qty: 1 GE Remote User Interface; (REF 5719003-01) Qty: 1 GE Hand Control OEC ELITE; (REF 5819193); Qty; 1 GE Foot Switch; (REF 1482807); Qty: 1 GE Skin Spacer - Squircular; (REF 5436688-01) Qty: 2

The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.

GUIDOR® Bioresorbable Matrix Barrier

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.

The GE OEC 9800 C-Arm system offers an increased resolution (1,000 x 1,000 pixel resolution vs the 9600’s 512 x 512), touch-screen controls, additional configurations (PMCare, Neuro-Vascular, and Cardiac packages), additional physical options such as MD Models (motorized movements), and increased storage options (additional image storage on disk as well as built-in DICOM). The c-arm was manufactured from 2000 to 2005 with the 9800 Plus models being manufactured from 2003-2005.