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# Intended Use / Indications for Use ### EPIQ: The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. ### Affiniti: The intended use of the Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging. The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

The purpose of this Special 510(k) Pre-Market Notification is to expand the Smart View Select (SVS) software application onto the Affiniti Series Diagnostic Ultrasound Systems and to modify the Smart View Select software application onto both the EPIQ Series Diagnostic Ultrasound Systems. Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning AI interface engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. No hardware changes to the EPIQ or Affiniti systems are required when using SVS, and existing, cleared Philips TTE transducers are used with these software applications. The SVS v2 feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software features are associated with the cardiac adult indication.

EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain TTE clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as "AutoStrain"), and AutoMeasure applications. The R-trigger algorithm is planned to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. The Auto-Measure and AutoStrain features support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients. The R-trigger feature (non-ECG-based) has been developed to enable clinical users to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, which is currently required. There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application. The software application is supported by all EPIQ and Affiniti models running software version 13.0 or higher.

Indications for Use Focal seizure detection (with or without secondary generalization) in patients with epilepsy age 6 years and older.

160 MHz 802.11ax Wi-Fi and Bluetooth 5.0 (Dual Band)

EPIQ: The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Intra-luminal, Intra-cardiac Echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Affiniti: The intended use of the Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The purpose of this Special 510(k) Pre-Market Notification is to modify the Segmental Wall Motion and introduce Auto EF with contrast software application onto the Philips EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems. SWM algorithm was previously cleared (K243862) and Auto EF contrast algorithm(K243235) was also previously cleared. The current software release version VM 13, replaces the previous version of the segmental wall motion algorithm included in version 11 of the software release with the current cleared version (K243862) without any modifications, and integrates Auto EF contrast algorithm(K243235) without any modifications into one software release. The SWM v2 software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The SWM v2 software is a semi-automated quantitative imaging algorithm, as users are generally expected to review and concur with the initial and generated results. The users can also manually edit algorithm-generated segmental wall motion scores for individual segments based on their clinical expertise. Auto EF with contrast is an AI based automated software feature that assists clinicians with assessing Left Ventricular Ejection Fraction (LVEF) from images acquired with contrast agent as part of an adult transthoracic echo (TTE) examination. The feature is located within the Philips Auto EF Adv application. Auto EF with contrast uses 2 apical views (Apical four chamber view (A4C), Apical two chamber (A2C)) and provides EF for each view and a biplane Simpsons EF. No hardware changes to the EPIQ or Affiniti systems were made due to the SWM v2 and Auto EF with contrast, and existing, cleared Philips TTE transducers are used with these software applications.

The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), Pulsed Wave Doppler (PWD), and M modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Fetal/Obstetric,Abdominal, Pediatric, Cephalic, Urology, Gynecological, Cardiac Fetal Echo, Small Organ,Musculoskeletal, Peripheral Vessel, Carotid, Cardiac, Lung, Ophthalmic. The Lumify system is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. The Lumify system is compatible with iOS and Android operating systems. The Lumify Diagnostic Ultrasound System (iOS) utilizes: 1. A commercial off-the-shelf (COTS) iOS mobile item (smart phone or tablet) 2. The Philips Ultrasound Lumify software running as a medical device application on the COTS device 3. The Philips C5-2 Curved array USB transducer 4. The Philips L12-4 Linear array USB transducer 5. The Philips S4-1 Sector array USB transducer 6. Lumify Micro B Transducer Cable 7. Lumify Micro C Transducer Cable 8. Lumify USB-C to USB-C Transducer Cable 9. Lumify Power Module The purpose of this Traditional 510k pre-market notification is to add Ocular preset to currently commercialized L12-4 transducer available with Lumify Diagnostic Ultrasound System. Addition of Ocular preset will be available under newly added Ophthalmic clinical indication, as part of this 510k submission. The Ocular Preset is an imaging setting to image the eye. It supports 2D (B Mode) and Color Doppler Mode and is available under "Ophthalmic" clinical indication. The ocular preset is available to download with the Lumify 5.1 software and is available with the previously commercialized L12-4 Lumify transducer.

The Flash Ultrasound System 5100 Point of Care (5100 POC and 5100 POC Pro) is indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Cerebral Vascular, Fetal/OB, Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Neonatal Cephalic, Ophthalmic, Other: Carotid, Other: GYN, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Trans-Esophageal (Cardiac), Trans-Vaginal. Modes of operation include B Mode (or 2D), Color Doppler, Color Power Angio Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-Mode (including anatomical M-Mode), Harmonics (Tissue), and Combined modes. The clinical environments where the Flash Ultrasound System 5100 POC may be used are: hospitals, surgery centers, clinics, physicians' offices, diagnostic centers, critical care and emergency room environments, and point-of-care clinical settings for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure.

The Flash Ultrasound System 5100 Point of Care (POC) device is constructed with assets from the previously cleared 5000 Compact Series hardware platform (K222648) and a new Rhythm software platform that is new to the POC environment. The Flash Ultrasound System 5100 POC supports a full touch screen interface on the main display as the primary means of directing the system, leveraging customer familiarity with smart devices and the ease of cleaning and maintenance of a pure glass surface. Additionally, Flash Ultrasound System 5100 POC is designed to fit into tight spaces in a crowded Emergency Room (ER) with its small footprint, sleek design, and a large vertical tablet with ergonomic controls. The new Rhythm software offers point-of-contact workflow enhanced with assisted needle visualization, streamline point-of-care workflows such as flexible patient data management and AutoStrain EF. In addition to these POC workflows, the Rhythm software provides enhanced responsiveness with an easy-to-learn user interface as all controls are located in the same plane as the user's eye and hand for working more efficiently with the patient. The Flash Ultrasound System 5100 POC has two models, the 5100 POC and the 5100 POC Pro. The 5100 POC version does not support two transducers, C5-1 and X8-2t; however, the 5100 POC Pro supports all the transducers listed for the system.

EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance. Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce Remote Software Management (RSM) software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new RSM software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K242020. The Philips RSM feature provides the capabilities to remotely upgrade EPIQ/Affiniti Systems, with the existing RSM capabilities, only patch upgrade was possible, and full upgrade (including OS components) was not supported. The full RSM feature provides the capabilities to perform a remote upgrade to EPIQ/Affiniti Systems. The RSM feature is capable of deploying following packages onto the system: OS Packages, Device Drivers, Printer Drivers, BIOS/UEFI version, Application Packages, Service Application Packages, Automatic backup/restore of existing system settings. Along with the above functionalities, it also supports Automatic and Scheduled software downloads/Installation. No hardware changes to the EPIQ or Affiniti Systems are required when using RSM software feature, and existing, commercialized Philips transducers are used for the RSM software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.

Indications for use of the product are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.

The purpose of this Traditional 510(k) Pre-market Notification is to introduce the SWM, 3D Auto TV and 3D Auto CFQ software applications as well as compatibility of VeriSight ICE / Pro ICE Probe data with the subject device Ultrasound Workspace Version 6.0. The semi-automated Segmental Wall Motion feature (SWM) evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. It performs border detection and tracking to identify each of the LV seqments, provides segmental wall motion scores for each segments of the LV by using machine learning algorithms and calculates an overall wall motion score index (WMSI) as the average of the segmental scores. 3D Auto TV software enables semi-automated quantification of the tricuspid valve. At a high level, this is accomplished through automatically derived measurements from a segmented model of the tricuspid valve annulus formed by the software through model-based segmentation of the acquired ultrasound images. 3D Auto CFQ provides semi-automated quantification of Mitral Requrgitation (MR) volume and peak flow rate based on 3D color flow images. This application uses a known fluid dynamic model of flow that is adapted to the acquired color information. This allows quantitative assessment of mitral valve leakage during systole. The derived result supports the assessment of mitral regurgitation volume and peak flow rate. Data Compatibility of the VeriSight ICE / Pro ICE Probe, transducers cleared for the EPIQ Series Diagnostic Ultrasound System (K202216), will be introduced for Ultrasound Workspace 6.0. General software architecture of the previously cleared version TOMTEC-ARENA remains unchanged. Two new clinical application packages will be introduced with UWS6.0: 3D Auto TV and 3D Auto CFQ. An existing feature AutoStrain Left Ventricle (AutoStrain LV) gains additional functionality by integration of Segmental Wall Motion (SWM) feature. The module using AutoStrain LV together with SWM is named 2D Auto LV.

EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode . Power Doppler and Harmonic Imaging. The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo quidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure. Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use. Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode , Power Doppler and Harmonic Imaging. The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems. Philips AutoMeasure feature provides the end user semi-automated 2D, Doppler and M-mode measurements with an adult cardiology transthoracic transducer and acquisitions that includes an electrocardiogram (ECG). The Auto Measure feature is designed to provide semi-automated and editable measures during an echocardiography. When Auto Measure is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semiautomated measurement that can be edited, accepted, or rejected. AutoMeasure is available in the Adult Echo analysis applications with ECG. Availability is also controlled by transducer and preset via the EPM. The software applications are supported by all EPIQ and Affiniti models running software version 13.0 or higher.