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QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. It can be used for the off-line review and quantification of ultrasound studies. QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. QLAB software functions through Q-App modules, each of which provides specific capabilities. QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products. Philips Ultrasound is submitting this 510(k) to address QLAB 11.0 modifications which include: - Dynamic Heart Model (DHM) an enhancement to the Heart Model Quantification ● application that provides tracking of the entire cardiac cycle - QLAB functionality upgraded to the HSDP Platform 2 from the HSDP Platform 1 ● - O-Store Shared central database supporting multiple clients. .

The PercuNav system is a stereotaxic accessory for computed tomography (CT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav system is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures. The PercuNav system also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting. The PercuNav system is also intended for use in clinical interventions to determine the proximity of one device relative to another. Example procedures include, but are not limited to, the following: - · Image fusion for diagnostic clinical examinations and procedures - · Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.) - · Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on) - Bone ablations - Bone biopsies - · Nerve blocks and pain management - Drainage placements - Tumor resections

The proposed PercuNav provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physician-defined targets. The target can be indicated either pre-procedurally or intra-procedurally, either using images or relative to an indicated position on the patient. The proposed PercuNav provides real-time, three-dimensional visualization and navigation tools for all stages of diagnosis and intervention, including pre-procedure planning and procedure navigation. The system transforms two-dimensional patient images into dynamic representations that can be fused with live ultrasound or other previously acquired images. Those two-dimensional patient images, or scan sets, are derived from Ultrasound, CT, PET, PET/CT, and MRI. The resulting dynamic representation supports diagnostic review and instrument navigation. The PercuNav system performs spatial mapping from one image space to another image space or from image space to physical space (registration), allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive diagnostic and interventional procedures. Features include the following: - Multiple Applications: The PercuNav system supports multiple applications and can be used for ablations, biopsies, and other diagnostic and guidance procedures. - Multiple Modalities: The PercuNav system works with images from multiple modalities, including but not limited to CT, MR, PET, and ultrasound.