Siemens Healthcare Diagnostics Products GmbH OQGR11 LA 2 Confirmation Reagent

This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.

This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.

BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM

SCREW, CANN. INT., FULL THREAD

SCRW,CANN. INT.,W/DISP SHTH

TIGHTROPE ABS, BUTTON, 8 X 12 MM

Torque Wrench Square Head Adaptor

These Stryker 3002 Ex Secure 2 Beds are in fully functional condition and include electric controls for adjusting the head, foot, and height positions, along with Trendelenburg capabilities. The bed has adjustable side rails and a secure braking system. It also features pressure-relief surfaces.

This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.

This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.