The intended use of the Affiniti 30, Affiniti 70 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 (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, 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, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes.

It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

The intended use of the EPIQ, EPIQ 7 is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, 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.

The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+Color), 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. Lumify is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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

Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel.

Device Description

Philip Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices which are intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN applications and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.

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' Diagnostic Ultrasound Systems.

Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips Diagnostic Ultrasound Systems and QLAB software and may vary among model configurations.

The diagnostic ultrasound systems are manufactured with hardware components which consist of:

a primary console (e.g., workstation, tablet) with built-in software components, features, and 1) various clinical applications, and
1. a range of compatible ultrasound transducers.

A suite of compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array, linear array and sector/ohased array transducer models which have a prefix "C" are designed to provide larger fields of view and penetration for e.g., consolidation between bone spaces while linear array transducer models, which can be identified with a "L" prefix model name are designed to provide shallow visualization which are optimal for tissue layer interfaces. Sector/phased array transducer models which usually have a "S" prefix model names are designed to be applied for difficult anatomical sites (e.g., cardiac intercostal space (ICS)). Other Philips ultrasound transducers may also start with the prefix "X" which is referring to the xMatrix technology for two full-resolution planes of imaging. Volumetric three-dimensional (3D) imaging functionality is also available when specific transducer models are connected to the primary console. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

AI/ML Overview

This document is a 510(k) Premarket Notification from Philips Ultrasound, Inc. to the FDA regarding several of their diagnostic ultrasound systems and software. The primary purpose of this submission is not to present performance data for a new device that meets acceptance criteria, but rather to assert substantial equivalence to previously cleared predicate devices for expanded labeling related to COVID-19.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies, does not apply in the traditional sense for a new device submission with novel performance claims.

Instead, the submission states:

1. A table of acceptance criteria and the reported device performance:

There is no specific table of acceptance criteria or reported device performance for novel features in this submission.
The document focuses on establishing technological characteristic equivalence between the subject devices and their respective predicate devices.
Table 1, Table 2, Table 3, Table 4, Table 5, and Table 6 (spanning pages 13-25) provide a technological comparison for each subject device (Philips Lumify, EPIQ, Affiniti, CX50, Sparq, and QLAB software) against its predicate device. For all listed "Standard Features" (Indications for Use, Reusable?, Duration of Use, Scientific Technology, Operating principles, Type of Previously-cleared Transducers, Acoustic Outputs Within Range?, Previously cleared Imaging Modes?, Biocompatibility), the comparison consistently states "Identical." This indicates that no new performance metrics or acceptance criteria beyond those already established for the predicate devices are being introduced for new functionalities.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The submission does not describe a new performance study requiring a test set. It relies on the equivalence of the subject devices to their predicate devices, which would have undergone performance testing for their initial clearances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new ground truth establishment is described in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No new performance study or test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study is mentioned. The submission is for existing ultrasound systems and software with expanded labeling, not for AI-assisted diagnostic tools requiring such studies for comparative effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. While QLAB is software, the submission primarily focuses on maintaining substantial equivalence in its current functionality and expanding labeling. No new standalone algorithm performance is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No new ground truth is described. The established safety and effectiveness of the predicate devices implicitly relied on various forms of ground truth relevant to diagnostic ultrasound at the time of their clearance.

8. The sample size for the training set:

Not applicable. This submission does not involve a new machine learning algorithm or a training set.

9. How the ground truth for the training set was established:

Not applicable. This submission does not involve a new machine learning algorithm or a training set.

Summary of the Submission's Approach:

The core of this 510(k) submission is to assert that the subject devices (various Philips Diagnostic Ultrasound Systems and QLAB software) are substantially equivalent to their respective predicate devices. The significant change being addressed is the "Expanded Labeling" to include information about lung and cardiac ultrasound imaging for COVID-19 patients, based on established methods or the latest society guidelines. The submission explicitly states:

"Relevant performance data does not apply to this submission." (Page 26)
"There are no changes in software, hardware, and intended uses of the subject devices comparing to the predicates." (Page 26)
"The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices." (Page 26)

Therefore, the "study" proving the device meets "acceptance criteria" is essentially the argument of identical technological characteristics and unchanged intended uses compared to the already cleared predicate devices, with the new labeling information being based on general clinical practice and guidelines rather than new device-specific performance data.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Ultrasound, Inc. % Deep Pal Director, Regulatory Affairs 22100 Bothell Everett Highway Bothell WA 98021

May 1, 2020

Re: K201012

Trade/Device Name: Affiniti Diagnostic Ultrasound System Series Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: April 17, 2020 Received: April 20, 2020

Dear Deep Pal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K201012

Device Name

Affiniti Diagnostic Ultrasound System Series

Indications for Use (Describe)

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care for diagnosis of patients.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K201012

Device Name CX50 Diagnostic Ultrasound System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K201012

Device Name

EPIQ Diagnostic Ultrasound System Series

Indications for Use (Describe)

The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K201012

Device Name Lumify Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K201012

Device Name

QLAB Advanced Quantification Software

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 201. Subpart D)
Over-The-Counter Use (21 CFR 201. Subpart C)

| X Prescription Use (Part 21 CFR 801 Subpart D)

|__ | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K201012

Device Name Sparq Diagnostic Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.

510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. Date Prepared: April 30, 2020

I. Submitter
Manufacturer Nameand Address	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431
ContactInformation	Deep PalHead of Regulatory AffairsTEL: +1 (425) 219-3412EMAIL: deep.pal@philips.com
Secondary ContactInformation	Benny LamPrincipal Regulatory Affairs SpecialistTEL: +1 (425)-215-3496EMAIL: benny.lam@philips.com
II. Device
Trade Name	Philips Lumify Diagnostic Ultrasound SystemPhilips EPIQ Diagnostic Ultrasound System SeriesPhilips Affiniti Diagnostic Ultrasound System SeriesPhilips CX50 Diagnostic Ultrasound SystemPhilips Sparq Diagnostic Ultrasound SystemPhilips QLAB Advanced Quantification Software
Common Name	Diagnostic ultrasound system and transducersAutomated Radiological Image Processing Software
Regulation Description	Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducerPicture archiving and communications system
Regulation Number	892.1550892.1560892.1570892.2050
Product Code	IYN
Secondary Product Codes	IYO

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ITX OIH

Device Class	Class II
Classification Panel	Radiology

III. Predicate Device

K192226 Philips Lumify Diagnostic Ultrasound System ■
K182857 Philips EPIQ Diagnostic Ultrasound System ■
l K182857 - Philips Affiniti Diagnostic Ultrasound System
K162329 Philips CX50 Diagnostic Ultrasound System ■
I K162329 - Philips Sparq Diagnostic Ultrasound System
K191647 - QLAB Advanced Quantification Software

IV. Device Description

The diagnostic ultrasound systems are manufactured with hardware components which consist of:

a primary console (e.g., workstation, tablet) with built-in software components, features, and 1) various clinical applications, and
1. a range of compatible ultrasound transducers.

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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is a bright blue. The letters are evenly spaced and the word is centered in the image.

SPECIAL 510(k) Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

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Device	Indications for Use
Philips LumifyDiagnosticUltrasoundSystem	Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined(B+Color), 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. Lumify is a transportable ultrasound system intended for use in environments wherehealthcare is provided by healthcare professionals.
Philips EPIQDiagnosticUltrasoundSystem	The intended use of the EPIQ, EPIQ 5, EPIQ 7 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flowanalysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), CardiacPediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular),Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, PeripheralVessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.The clinical environments where the EPIQ Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinicalpoint-of-care for diagnosis of patients.When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance duringtreatment 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 operatinginstructions given in the product user information, and only for the purposes for which it was designed. However, nothing statedin the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
Philips AffinitiDiagnosticUltrasoundSystem	The intended use of the Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imagingand 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.The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinicalpoint-of-care for diagnosis of patients.When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance duringtreatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
Device	Indications for Use
Philips CX50DiagnosticUltrasoundSystem	The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operatinginstructions given in the product user information, and only for the purposes for which it was designed. However, nothing statedin the user information reduces your responsibility for sound clinical judgement and best clinical procedure
	Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (includingAnatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics(Tissue and Contrast) modes.It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic IntraoperativeLaparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletalGynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)
Philips SparqDiagnosticUltrasoundSystem	Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2- D), M-mode (includingAnatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics(Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal GynecologicalCardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel
QLABAdvancedQuantificationsoftware	QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image dataacquired on Philips ultrasound systems.

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Page 6 of 19

VI. Comparison of Technological Characteristics with the Predicate Device

Table 1: Technological Comparison of Subject Device (i.e., Philips Lumify Diagnostic Ultrasound System) & Predicate Device

Standard Feature	Philips Lumify Ultrasound SystemK# Pending(Subject Device)	Philips Lumify DiagnosticUltrasound SystemK192226(Predicate Device)	Comparison
Indications for Use	Philips Lumify Diagnostic UltrasoundSystem is intended for diagnosticultrasound imaging in B (2D), ColorDoppler, Combined (B+Color), and Mmodes. It is indicated for diagnosticultrasound imaging and fluid flowanalysis in the following applications:Fetal/Obstetric, Abdominal, Pediatric,Cephalic, Urology, Gynecological,Cardiac Fetal Echo, Small Organ,Musculoskeletal, Peripheral Vessel,Carotid, Cardiac. Lumify is atransportable ultrasound systemintended for use in environments wherehealthcare is provided by healthcareprofessionals.	Philips Lumify Diagnostic UltrasoundSystem is intended for diagnosticultrasound imaging in B (2D), ColorDoppler, Combined (B+Color), and Mmodes. It is indicated for diagnosticultrasound imaging and fluid flowanalysis in the following applications:Fetal/Obstetric, Abdominal, Pediatric,Cephalic, Urology, Gynecological,Cardiac Fetal Echo, Small Organ,Musculoskeletal, Peripheral Vessel,Carotid, Cardiac. Lumify is atransportable ultrasound systemintended for use in environments wherehealthcare is provided by healthcareprofessionals.	Identical
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
ScientificTechnology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operatingprinciples	Compatible device generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.	Compatible device generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.	Identical
Standard Feature	Philips Lumify Ultrasound SystemK# Pending(Subject Device)	Philips Lumify DiagnosticUltrasound SystemK192226(Predicate Device)	Comparison
	Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.	Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.
Type of Previously-clearedTransducers	Curved ArrayLinear ArraySector Array	Curved ArrayLinear ArraySector Array	Identical
Acoustic OutputsWithin Range?	Yes	Yes	Identical
Previously clearedImaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 7 of 19

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Page 8 of 19

Table 2: Technological Comparison of Subject Device (i.e., Philips EPIQ Diagnostic Ultrasound System Series) & Predicate Device

Standard Feature	Philips EPIQ Diagnostic UltrasoundSystem SeriesK# Pending	Philips EPIQ Diagnostic UltrasoundSystem SeriesK182857	Comparison
	(Subject Device)	(Predicate Device)
Indications for Use	The intended use of the EPIQ, EPIQ 5,EPIQ 7 Diagnostic Ultrasound Systemsis diagnostic ultrasound imaging andfluid flow analysis of the human bodywith the following Indications for Use:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, CerebralVascular, 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.The clinical environments where theEPIQ Diagnostic Ultrasound Systemscan be used include Clinics, Hospitals,and clinical point-of-care for diagnosis ofpatients.When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon withimage guidance during treatment of	The intended use of the EPIQ, EPIQ 5,EPIQ 7 Diagnostic Ultrasound Systemsis diagnostic ultrasound imaging andfluid flow analysis of the human bodywith the following Indications for Use:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, CerebralVascular, 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.The clinical environments where theEPIQ Diagnostic Ultrasound Systemscan be used include Clinics, Hospitals,and clinical point-of-care for diagnosis ofpatients.When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon withimage guidance during treatment of	Identical
Standard Feature	Philips EPIQ Diagnostic UltrasoundSystem SeriesK# Pending(Subject Device)	Philips EPIQ Diagnostic UltrasoundSystem SeriesK182857(Predicate Device)	Comparison
	cardiovascular disease in which theprocedure uses both live X-ray and liveEcho Guidance.The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposesfor which it was designed. However,nothing stated in the user informationreduces your responsibility for soundclinical judgement and best clinicalprocedure.	cardiovascular disease in which theprocedure uses both live X-ray and liveEcho Guidance.The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposesfor which it was designed. However,nothing stated in the user informationreduces your responsibility for soundclinical judgement and best clinicalprocedure.
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
ScientificTechnology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operatingprinciples	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that are	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that are	Identical
Standard Feature	Philips EPIQ Diagnostic UltrasoundSystem SeriesK# Pending(Subject Device)	Philips EPIQ Diagnostic UltrasoundSystem SeriesK182857(Predicate Device)	Comparison
	reflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.	reflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.
Type of Previously-clearedTransducers	Curved ArrayLinear ArraySector Array	Curved ArrayLinear ArraySector Array	Identical
Acoustic OutputsWithin Range?	Yes	Yes	Identical
Previously clearedImaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical
Standard Feature	Philips Affiniti DiagnosticUltrasound System SeriesK# Pending(Subject Device)	Philips Affiniti DiagnosticUltrasound System SeriesK182857(Predicate Device)	Comparison
Indications for Use	The intended use of the Affiniti 30,Affiniti 50 and Affiniti 70 DiagnosticUltrasound Systems is diagnosticultrasound imaging and fluid flowanalysis of the human body with thefollowing Indications for Use:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, CerebralVascular, 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.The clinical environments where theAffiniti Diagnostic Ultrasound Systemscan be used include Clinics, Hospitals,and clinical point-of-care for diagnosis ofpatients.When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon with	The intended use of the Affiniti 30,Affiniti 50 and Affiniti 70 DiagnosticUltrasound Systems is diagnosticultrasound imaging and fluid flowanalysis of the human body with thefollowing Indications for Use:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, CerebralVascular, 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.The clinical environments where theAffiniti Diagnostic Ultrasound Systemscan be used include Clinics, Hospitals,and clinical point-of-care for diagnosis ofpatients.When integrated with PhilipsEchoNavigator, the systems can assistthe interventionalist and surgeon with	Identical
Standard Feature	Philips Affiniti DiagnosticUltrasound System SeriesK# Pending(Subject Device)	Philips Affiniti DiagnosticUltrasound System SeriesK182857(Predicate Device)	Comparison
	image guidance during treatment ofcardiovascular disease in which theprocedure uses both live X-ray and liveEcho Guidance.The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposesfor which it was designed. However,nothing stated in the user informationreduces your responsibility for soundclinical judgement and best clinicalprocedure.	image guidance during treatment ofcardiovascular disease in which theprocedure uses both live X-ray and liveEcho Guidance.The systems are intended to be installed,used, and operated only in accordancewith the safety procedures and operatinginstructions given in the product userinformation, and only for the purposesfor which it was designed. However,nothing stated in the user informationreduces your responsibility for soundclinical judgement and best clinicalprocedure.
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
ScientificTechnology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operatingprinciples	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucus	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucus	Identical
Standard Feature	Philips Affiniti DiagnosticUltrasound System SeriesK# Pending(Subject Device)	Philips Affiniti DiagnosticUltrasound System SeriesK182857(Predicate Device)	Comparison
	membrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.	membrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.
Type of Previously-clearedTransducers	Curved ArrayLinear ArraySector Array	Curved ArrayLinear ArraySector Array	Identical
Acoustic OutputsWithin Range?	Yes	Yes	Identical
Previously clearedImaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical
Standard Feature	Philips CX50 Diagnostic UltrasoundSystemK# Pending	Philips CX50 Diagnostic UltrasoundSystemK162329	Comparison
	(Subject Device)	(Predicate Device)
Indications for Use	Philips CX50 Diagnostic UltrasoundSystems is intended for diagnosticultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode),Pulse Wave Doppler, Continuous WaveDoppler, Color Doppler, Tissue DopplerImaging and Harmonics (Tissue andContrast) modes.It is indicated for diagnostic ultrasoundimaging and fluid flow analysis in thefollowing applications: OphthalmicIntraoperative Laparoscopic FetalAbdominal Pediatric Small Organ AdultCephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal GynecologicalCardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echoPeripheral Vessel Other (Carotid)	Philips CX50 Diagnostic UltrasoundSystems is intended for diagnosticultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode),Pulse Wave Doppler, Continuous WaveDoppler, Color Doppler, TissueDoppler Imaging and Harmonics (Tissueand Contrast) modes.It is indicated for diagnostic ultrasoundimaging and fluid flow analysis in thefollowing applications: OphthalmicIntraoperative Laparoscopic FetalAbdominal Pediatric Small Organ AdultCephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal GynecologicalCardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echoPeripheral Vessel Other (Carotid)	Identical
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
ScientificTechnology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operatingprinciples	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate its	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate its	Identical
Standard Feature	Philips CX50 Diagnostic UltrasoundSystemK# Pending(Subject Device)	Philips CX50 Diagnostic UltrasoundSystemK162329(Predicate Device)	Comparison
	piezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.	piezoelectric elements at the distal end.Stimulation causes the elements toexpand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.
Type of Previously-clearedTransducers	Curved ArrayLinear ArraySector Array	Curved ArrayLinear ArraySector Array	Identical
Acoustic OutputsWithin Range?	Yes	Yes	Identical
Previously clearedImaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical
Standard Feature	Philips Sparq Diagnostic UltrasoundSystemK# Pending(Subject Device)	Philips Sparq Diagnostic UltrasoundSystemK162329(Predicate Device)	Comparison
Indications for Use	Philips Sparq Diagnostic UltrasoundSystem is intended for diagnosticultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode),Pulse Wave Doppler, Continuous WaveDoppler, Color Doppler, Tissue DopplerImaging and Harmonics (Tissue andContrast) modes. It is indicated fordiagnostic ultrasound imaging and fluidflow analysis in the followingapplications: Ophthalmic FetalAbdominal Pediatric Small Organ AdultCephalic Trans-vaginal Trans-rectalMusculo-skeletal Gynecological CardiacAdult Trans-Esoph. (Cardiac) PeripheralVessel	Philips Sparq Diagnostic UltrasoundSystem is intended for diagnosticultrasound imaging in B (or 2- D), M-mode (including Anatomical M-mode),Pulse Wave Doppler, Continuous WaveDoppler, Color Doppler, TissueDoppler Imaging and Harmonics (Tissueand Contrast) modes. It is indicated fordiagnostic ultrasound imaging and fluidflow analysis in the followingapplications: Ophthalmic FetalAbdominal Pediatric Small Organ AdultCephalic Trans-vaginal Trans-rectalMusculo-skeletal Gynecological CardiacAdult Trans-Esoph. (Cardiac) PeripheralVessel	Identical
Reusable?	Yes	Yes	Identical
Duration of Use	Limited (≤ 24 hours)	Limited (≤ 24 hours)	Identical
ScientificTechnology	Ultrasound Imaging	Ultrasound Imaging	Identical
Operatingprinciples	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements to	System console generates electricalcurrent and sends to a connected,compatible transducer to stimulate itspiezoelectric elements at the distal end.Stimulation causes the elements to	Identical
Standard Feature	Philips Sparq Diagnostic UltrasoundSystemK# Pending(Subject Device)	Philips Sparq Diagnostic UltrasoundSystemK162329(Predicate Device)	Comparison
	expand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.	expand and contract which creates ahigh-pressured wave (i.e., soundwave). Aseries of soundwaves then propagatetoward tissue medium (e.g., mucusmembrane, bone). The transducer thenreceives echoed soundwaves that arereflected from the tissue medium andtransmits it to the system. The systemprocesses the echoed soundwaves intoan image which is displayed on thedisplay monitor screen of the system foruser interpretation.
Type of Previously-clearedTransducers	Curved ArrayLinear ArraySector Array	Curved ArrayLinear ArraySector Array	Identical
Acoustic OutputsWithin Range?	Yes	Yes	Identical
Previously clearedImaging Modes?	Yes	Yes	Identical
Biocompatibility	ISO 10993-1	ISO 10993-1	Identical

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 9 of 19

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 10 of 19

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Page 11 of 19

Table 3: Technological Comparison of Subject Device (i.e., Philips Affiniti Diagnostic Ultrasound System Series) & Predicate Device

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 12 of 19

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 13 of 19

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Table 4: Technological Comparison of Subject Device (i.e., Philips CX50 Diagnostic Ultrasound System) & Predicate Device

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 15 of 19

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Table 5: Technological Comparison of Subject Device (i.e., Philips Sparq Diagnostic Ultrasound System) & Predicate Device

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Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLAB Devices

Page 17 of 19

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PHILIPS	SPECIAL 510(K)Expanded Labeling for Lumify/EPIQ/Affiniti/CX50/Sparq/QLABDevices	Page 18 of 19
	Table 6: Technological Comparison of Subject Device (i.e., QLAB Advanced Quantification Software) & Predicate Device
Standard Feature	QLAB Advanced QuantificationSoftwareK# Pending(Subject Device)	QLAB Advanced QuantificationSoftwareK191647(Predicate Device)	Comparison
Indications for Use	QLAB Advanced QuantificationSoftware is a software applicationpackage. It is designed to view andquantify image data acquired on Philipsultrasound systems.	QLAB Advanced QuantificationSoftware is a software applicationpackage. It is designed to view andquantify image data acquired on Philipsultrasound systems.	Identical
ApplicationDescriptions	Semiautomatic border detection,chamber identification, contourgeneration, measurement parameters	Semiautomatic border detection,chamber identification, contourgeneration, measurement parameters	Identical

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VII. Performance Data

Relevant performance data does not apply to this submission. Design control measures are described within submission support a decision of substantial equivalence.

VIII. Conclusion

There are no changes in software, hardware, and intended uses of the subject devices comparing to the predicates. User labeling for the subject devices has been expanded to include information about lung and cardiac ultrasound imaging, based on established methods or the latest society guidelines, for patients with coronavirus disease 2019 (COVID-19). The results of the design controls activity support a determination that the subject devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate devices.

Image /page/26/Picture/7 description: The image shows the Philips logo. The logo consists of a blue circle with a white wave pattern inside. There are also four white stars inside the circle. The Philips logo is a well-known symbol associated with the company's brand.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.