APPLE INC. Feature Version 3.x Cycle Tracking 3.0

S2186 NovoTHOR Gen 3.0 XL PRX

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending.The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required.Length – approximately 36” / Weight – approximately 5 oz.

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.

Transfusion Manager is a comprehensive software application intended for use by trained healthcare professionals responsible for transfusion services. Transfusion Manager helps users manage the following transfusion service activities:• Positively identify transfusion recipients• Match blood products to recipients• Record recipient pertinent transfusion information• Record recipient transfusion reactions and caregiver comments