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 Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

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

The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel. The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application. The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Philips CX50 and Sparq Diagnostic Ultrasound Systems are implicitly defined by compliance with several international and FDA-recognized consensus standards, as well as the FDA's specific guidance for diagnostic ultrasound systems. The reported device performance is that it complies with these standards and guidances, and meets the acceptance criteria.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance Standards	IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance. 2005. Amendment 1, 2012 (General electrical and safety requirements)	Complies
	IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007 (Electromagnetic Compatibility - EMC)	Complies
	IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007 (Specific safety and performance requirements for ultrasound equipment)	Complies
	IEC 62359: Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010 (Acoustic Output Display & FDA Limits: ISPTA max=720 mW/cm², MI max=1.9, MI display, TI display)	Complies; acoustic output levels are within Track 3 FDA limits.
	ISO 10993: Biological evaluation of medical devices (Biological compatibility of patient contact materials)	Complies; materials have equivalent bio-safety, no new or changed materials.
FDA Guidance	Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008)	Complies
System Level Requirements	Satisfy system level requirements and risk control measures.	Non-Clinical verification testing performed and demonstrates compliance.
Intended Use & Claims	Covered intended use and commercial claims as well as usability with representative intended users.	Non-Clinical validation testing performed and demonstrates the device is adequate for its intended use.
Substantial Equivalence	The modified CX50 and Sparq Diagnostic Ultrasound Systems are substantially equivalent to the predicate CX50 Diagnostic Ultrasound System (K123754) and reference predicate EPIQ Diagnostic Ultrasound System (K160807) in terms of: - Indication for use - Technological characteristics - Non-clinical performance testing - Safety and effectiveness These devices share the same gray-scale and Doppler capabilities, fundamentally identical scientific technology, same materials (bio-safety), equivalent quality systems, and same electrical and physical safety standards.	This is the primary conclusion of the submission, based on the non-clinical testing, confirming that the device meets the acceptance criteria for substantial equivalence to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The modified CX50 and Sparq Diagnostic Ultrasound Systems did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System and reference predicate EPIQ Diagnostic Ultrasound System was demonstrated with the following attributes: • Indication for use; • Technological characteristics; • Non-clinical performance testing; and • Safety and effectiveness." (Page 39)

Therefore, there appears to be no separate clinical test set in the traditional sense for evaluating the performance of the modified device against specific clinical metrics. Instead, the performance was established through non-clinical testing and comparison to legally marketed predicate devices.

The data provenance for the modifications is based on the previously cleared predicate device (CX50, K123754) and reference device (EPIQ/Affiniti, K160807), which would have undergone their own testing. The current submission relies on the established safety and effectiveness of these predicates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical test set was required for the modified device, there's no information provided about experts establishing ground truth for a test set. The evaluation was primarily non-clinical and comparative.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set with human interpretation was conducted for this specific 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No MRMC comparative effectiveness study was mentioned or indicated as being performed for this submission. The submission explicitly states "did not require clinical data."

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This refers to a diagnostic ultrasound system, which is a hardware device with software, not typically a standalone algorithm like AI software. The performance assessment was based on the system's ability to acquire and display ultrasound data in various modes, complying with established physical and safety standards. Therefore, an "algorithm only" standalone performance study in the context of an AI-driven system is not applicable here.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established by the engineering and quality control standards defined in the referenced IEC and ISO standards. This includes:

Engineering specifications and measurements for acoustic output (e.g., ISPTA, MI, TI).
Compliance with electrical and physical safety requirements.
Biocompatibility testing against ISO 10993 standards for materials.
Verification and validation against system requirements and risk controls.

The ground truth for the predicate devices (K123754 and K160807) would have involved comprehensive testing for their initial clearances, which may have included a combination of phantom studies, animal studies, and potentially clinical studies to establish their diagnostic capabilities. However, this submission specifically highlights that additional clinical data was not required due to the substantial equivalence argument.

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The system's functionalities are based on established ultrasound physics and engineering principles, not statistical learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 14, 2016

Philips Healthcare % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K162329

Trade/Device Name: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 17, 2016 Received: August 19, 2016

Dear Mr. Job:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K162329 510(k) Number (if known)

Device Name

CX50 Diagnostic Ultrasound System

Indications for Use (Describe)

Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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FORM FDA 3881 (8/14) Publishing Services (301) 443-6740

Page 1 of 1 EF

PSC

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Traditional 510(k)

CX50 and Sparq Diagnostic Ultrasound Systems

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic	P	P	P		P	P	P (1,4,6,7)
	Fetal/Obstetric	P	P	P	P	P	P	P (1,3-8)
	Abdominal	P	P	P	P	P	P	P (1,3-9)
	Intraoperative(vascular/epicardial)	P	P	P		P	P	P (1,3,4,5,7)
	Intraoperative (Neuro)
	Laparoscopic	P	P	P		P	P	P (1,3,4,5,7)
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1,3-8)
	Small Organ (thyroid,scrotum, prostate, breast)	P	P	P		P	P	P (1,3-8)
	Neonatal Cephalic	P	P	P	P	P	P	P(1-8)
	Adult Cephalic	P	P	P	P	P	P	P (1,3-7)
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P (1,3-8)
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel(conventional)	P	P	P		P	P	P (1,3-8)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3-8)
	Other (Gynecological)	P	P	P		P	P	P (1,3-9)
	Cardiac Adult	P	P	P	P	P	P	P(1-4)
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P (1-7)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P(1-4)
	Other (Intracardiac)	P	P	P	P	P	P	P (1-7)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P	P	P	P	P (1,3-8)
	Other (Carotid)	P	P	P		P	P	P (1,3-8)
	N= new indication; P= previously cleared by FDA
*Other modes:				5. Angio Imaging
	1. Harmonics (Tissue or Contrast)			6. 3D Imaging
	2. Tissue Doppler Imaging			7. SonoCT
	3. iSCAN						8. Biopsy guidance
	4. X-Res						9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

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	Philips Ultrasound, Inc
--	-------------------------	--

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

C5-1 transducer for use with CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application				Mode of Operation
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
General(Track IOnly)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1,3-8)
	Abdominal	P	P	P		P	P	P (1,3-9)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1,3-9)
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3-8)
	Other (Gynecological)	P	P	P		P	P	P (1,3-9)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3-8)
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:						5. Angio Imaging
1. Harmonics (Tissue & Contrast)			6. 3D Imaging
2. Tissue Doppler Imaging			7. SonoCT
3. iSCAN			8. Biopsy guidance
4. X-Res						9. Infertility monitoring of follicle development
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics
Clinical Application	Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1,3-8)
	Abdominal	P	P	P		P	P	P (1,3-9)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1,3-8)
	Small Organ (thyroid, scrotum,prostate, breast)	P	P	P		P	P	P (1,3-8)
	Neonatal Cephalic	P	P	P		P	P	P (1-8)
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,3-8)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3-8)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3-8)
	Other (Carotid)	P	P	P		P	P	P (1,3-8)
	N= new indication; P= previously cleared by FDA
*Other modes:						5. Angio Imaging
	1. Harmonics (Tissue & Contrast)					6. 3D Imaging
	2. Tissue Doppler Imaging					7. SonoCT
	3. iSCAN					8. Biopsy guidance
4. X-Res9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P (1,3,4,5,7)
	Intraoperative(vascular/epicardial)	P	P	P		P	P	P (1,3,4,5,7)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)	P	P	P		P	P	P (1,3,4,5,7)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:	1. Harmonics (Tissue & Contrast)		5. Angio Imaging
	2. Tissue Doppler Imaging		6. 3D Imaging
	3. iSCAN		7. SonoCT
4. X-Res		8. Biopsy guidance
			9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1,3-8)
	Abdominal	P	P	P		P	P	P (1,3-9)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P (1,3-9)
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)	P	P	P		P	P	P (1,3-9)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
N= new indication; P= previously cleared by FDA
*Other modes:			5. Angio Imaging
	1. Harmonics (Tissue & Contrast)		6. 3D Imaging
	2. Tissue Doppler Imaging		7. SonoCT
3. iSCAN			8. Biopsy guidance
4. X-Res			9. Infertility monitoring of follicle development
			Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
Clinical Application			Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1,3-8)
	Abdominal	P	P	P		P	P	P (1,3-9)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P (1,3-9)
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)	P	P	P		P	P	P (1,3-9)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Specify)
	N= new indication; P= previously cleared by FDA
*Other modes:			5. Angio Imaging
	1. Harmonics (Tissue & Contrast)			6. 3D Imaging
	2. Tissue Doppler Imaging			7. SonoCT
3. iSCAN				8. Biopsy guidance
4. X-Res				9. Infertility monitoring of follicle development
				Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50

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510(k) Number:

C8-5 transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

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510(k) Number:

C9-3io transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

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510(k) Number:

Device name: C9-3v transducer for use with CX50 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics Prescription Use (Per 21 CFR 801.109)

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510(k) Number:

Device name: C10-3v transducer for use with CX50 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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510(k) Number:

Device name: D2cwc transducer for use with CX50 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
* Other modes:
Combined modes:
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
Cardiac	Cardiac Adult					P		P (1-7)
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel				P
	Other (Carotid)				P
	N= new indication; P= previously cleared by FDA
*Other modes:
	5. Angio Imaging
	1. Harmonics (Tissue & Contrast)
	6. 3D Imaging
	2. Tissue Doppler Imaging
	7. SonoCT
	3. iSCAN
	8. Biopsy guidance
	4. X-Res
	9. Infertility monitoring of follicle development

	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
Previous submission: K123754 - CX50
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic	P	P	P		P	P	P (1,3,4,5,7)
	Pediatric
	Small Organ (thyroid,scrotum, prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac echo)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Specify)
N= new indication; P= previously cleared by FDA
*Other modes:					5. Angio Imaging
	1. Harmonics (Tissue & Contrast)				6. 3D Imaging
	2. Tissue Doppler Imaging				7. SonoCT
	3. iSCAN				8. Biopsy guidance
	4. X-Res				9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application			Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
(Track IOnly)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P (1,3-8)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1,3-8)
	Small Organ (thyroid, scrotum,prostate, breast)	P	P	P		P	P	P (1,3-8)
	Neonatal Cephalic	P	P	P		P	P	P (1-8)
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,3-8)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3-8)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3-8)
	Other (Carotid)	P	P	P		P	P	P (1,3-8)
N= new indication; P= previously cleared by FDA
*Other modes:			5. Angio Imaging
1. Harmonics (Tissue & Contrast)				6. 3D Imaging
2. Tissue Doppler Imaging			7. SonoCT
3. iSCAN			8. Biopsy guidance
4. X-Res			9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1,4,6,7,8)
	Abdominal	P	P	P		P	P	P (1,4,6,7,8)
	Intra-operative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P(1,4,6,7,8)
	Small Organ (thyroid, scrotum,prostate, breast)	P	P	P		P	P	P (1,4,6,7,8)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,4,6,7,8)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,4,6,7,8)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac echo)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P(1,4,6,7,8)
	Other (Carotid)	P	P	P		P	P	P (1,4,6,7,8)
	N= new indication; P= previously cleared by FDA
	*Other modes:		5. Angio Imaging
	1. Harmonics (Tissue & Contrast)		6. 3D Imaging
	2. Tissue Doppler Imaging		7. SonoCT
	3. iSCAN		8. Biopsy guidance
	4. X-Res		9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754-CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	Color Doppler	Combined (Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)	P	P	P		P	P	P (1,3,4,5,7)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid,scrotum, prostate, breast)	P	P	P		P	P	P (1,3,4,5,7)
	Neonatal Cephalic	P	P	P		P	P	P (1,3,4,5,7)
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,3,4,5,7)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3,4,5,7)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3,4,5,7)
	Other (Carotid)
N= new indication; P= previously cleared by FDA
*Other modes:
1. Harmonics (Tissue & Contrast)	5. Angio Imaging
2. Tissue Doppler Imaging	6. 3D Imaging
3. iSCAN	7. SonoCT
4. X-Res	8. Biopsy guidance
	9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P	P	P	P	P (1-4,6)
	Abdominal	P	P	P	P	P	P	P (1-4,6)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1-4,6)
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic	P	P	P	P	P	P	P (1-4,6)
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
	Cardiac Adult	P	P	P	P	P	P	P (1-4,6)
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P (1-4,6)
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:				5. Angio Imaging
	1. Harmonics (Tissue & Contrast)		6. 3D Imaging
	2. Tissue Doppler Imaging			7. SonoCT
3. iSCAN		8. Biopsy guidance
	4. X-Res		9. Infertility monitoring of follicle development
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{11}------------------------------------------------

510(k) Number:

Device name: D5cwc transducer for use with CX50 Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

{12}------------------------------------------------

510(k) Number:

Device name: L10-4lap transducer for use with CX50 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{13}------------------------------------------------

510(k) Number:

L12-3 transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

{14}------------------------------------------------

510(k) Number:

Device name: L12-5 50 transducer for use with CX50 Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{15}------------------------------------------------

510(k) Number:

L15-7io transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{16}------------------------------------------------

510(k) Number:

S12-4 transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{17}------------------------------------------------

	Philips Ultrasound, Inc
--	-------------------------	--

CX50 and Sparq Diagnostic Ultrasound Systems

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

S5-1 transducer for use with CX50 Diagnostic Ultrasound System Device name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic	P	P	P		P	P	P(1,4,6,7)
FetalImaging& Other	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P (1,3-8)
	Intra-operative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic	P	P	P	P	P	P	P (1-8)
	Adult Cephalic	P	P	P	P	P	P	P (1,3-7)
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P
	Cardiac Pediatric	P	P	P	P	P	P	P (1-7)
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:
	1. Harmonics (Tissue & Contrast)	5. Angio Imaging
	2. Tissue Doppler Imaging	6. 3D Imaging
	3. iSCAN	7. SonoCT
	4. X-Res	8. Biopsy guidance
		9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P (1-5)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Specify)
	N= new indication; P= previously cleared by FDA
*Other modes:	1. Harmonics (Tissue & Contrast)			5. Angio Imaging
	2. Tissue Doppler Imaging			6. 3D Imaging
	3. iSCAN			7. SonoCT
	4. X-Res			8. Biopsy guidance
				9. Infertility monitoring of follicle development
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: S7-3t cleared in K160807 – EPIQ
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application	Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P	P	P	P	P (1-4,6)
	Abdominal	P	P	P	P	P	P	P (1-4,6)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1-4,6)
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic	P	P	P	P	P	P	P (1-4,6)
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1-4,6)
	Musculo-skel (superficial)	P	P	P		P	P	P (1-4,6)
	Other (Gynecological)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P (1-4,6)
	Cardiac Pediatric	P	P	P	P	P	P	P (1-4,6)
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:	1. Harmonics (Tissue & Contrast)		5. Angio Imaging
	2. Tissue Doppler Imaging		6. 3D Imaging
	3. iSCAN		7. SonoCT
	4. X-Res		8. Biopsy guidance
	9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754-CX50
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application				Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
(Track IOnly)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P (1-6)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:
	1. Harmonics (Tissue & Contrast)		5. Angio Imaging
	2. Tissue Doppler Imaging		6. 3D Imaging
	3. iSCAN		7. SonoCT
	4. X-Res		8. Biopsy guidance
			9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Clinical Application	Mode of Operation
	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
General(Track IOnly)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Gynecological)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)	P	P	P	P	P		P (1-7)
	Other (Fetal)
PeripheralVessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:						5. Angio Imaging
	1. Harmonics (Tissue & Contrast)				6. 3D Imaging
	2. Tissue Doppler Imaging				7. SonoCT
	3. iSCAN				8. Biopsy guidance
	4. X-Res					9. Infertility monitoring of follicle development
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
	Previous submission: K123754 - CX50
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED)

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{18}------------------------------------------------

510(k) Number:

S7-3t transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{19}------------------------------------------------

510(k) Number:

S8-3 transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{20}------------------------------------------------

510(k) Number:

X7-2t transducer for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{21}------------------------------------------------

510(k) Number:

St. Jude Medical ViewFlex Xtra (K121381) for use with CX50 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

{22}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31,

2017 See PRA Statement below.

K162329 510(k) Number (if known)

Device Name

Sparq Diagnostic Ultrasound System

Indications for Use (Describe)

Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel

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

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

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.

{23}------------------------------------------------

Philips Ultrasound, Inc

Traditional 510(k)

CX50 and Sparq Diagnostic Ultrasound Systems

Department of Health and Human Services Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) Publishing Services (301) 443-6740

Page 1 of 1 EF

PSC

{24}------------------------------------------------

510(k) Number:

Device name: Philips Ultrasound, Inc. Sparq Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic	N	N	N	N	N	N	N (1,3-7)
	Fetal/Obstetric	N	N	N	N	N	N	N (1,3-7)
	Abdominal	N	N	N	N	N	N	N (1,3-8)
	Intra-operative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid,scrotum, prostate, breast)	N	N	N	N	N	N	N (1,3-8)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N (1,3-7)
	Trans-rectal	N	N	N	N	N	N	N (1,3-7)
	Trans-vaginal	N	N	N	N	N	N	N (1,3-7)
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel(conventional)	N	N	N	N	N	N	N (1,3-7, 8)
	Musculo-skel (superficial)	N	N	N	N	N	N	N (1,3-7, 8)
	Other (Gynecological)	N	N	N	N	N	N	N (1,3-7)
	Cardiac Adult	N	N	N	N	N	N	N (1-5, 7, 8)
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N (1,3,4)
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N	N (1,3-7, 8)
	Other (Specify)
	N= new indication; P= previously cleared by FDA
Other Modes1. Harmonic (Tissue or Contrast)2. Tissue Doppler Imaging3. iScan4. X-Res			5. Angio Imaging6. SonoCT7. Biopsy Guidance8. Needle Visualization*
	Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
Previous submission: K123754 - CX50. K160807 - EPIO

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109

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	Philips Ultrasound, Inc
--	-------------------------	--

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

C5-1 transducer for use with Sparq Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric	P	P	P		P	P	P (1, 3-7)
	Abdominal	P	P	P		P	P	P (1, 3-7)
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	P (1, 3-7)
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)	P	P	P		P	P	P (1, 3-7)
	Other (Gynecological)	P	P	P		P	P	P (1, 3-7)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1, 3-7)
	Other (Carotid)
Clinical Application			Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P (1, 3-7)
	Abdominal	P	P	P		P	P	P (1, 3-7)
	Intra-operative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (thyroid, scrotum,breast)	N	N	N		N	N	N (1, 3-7)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel (conventional)	N	N	N		N	N	N (1, 3-7)
	Musculo-skel (superficial)
	Intra-luminal
	Other (Gynecological)	P	P	P		P	P	P (1, 3-7)
	Cardiac Adult	N	N	N		N	N	N (1-4, 7)
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N		N	N	N (1, 3-7)
	Other (Carotid, I/O)
	N= new indication; P= previously cleared by FDA
Other Modes					5. Angio Imaging
1. Harmonic (Tissue or Contrast)					6. SonoCT
2. Tissue Doppler Imaging					7. Biopsy Guidance
3. iScan						8. Needle Visualization*
4. X-Res
	Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
	Previous submission: K160807 - Affiniti

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Philips Ultrasound, Inc

Traditional 510(k)

CX50 and Sparq Diagnostic Ultrasound Systems

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

Device name: C6-2 Transducer for use with Sparq Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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510(k) Number:

Device name: C9-4v Transducer for use with Sparq Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P (1, 3-7)
	Abdominal
	Intra-operative(Abdominal, vascular)
	Intra-operative (Neuro.)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ	N	N	N		N	N	N (1, 3-7)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N (1, 3-7)
	Trans-vaginal	P	P	P		P	P	P (1, 3-7)
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (Gynecological)	P	P	P		P	P	P (1, 3-7)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal(Cardiac)
	Other (Specify)

PeripheralVessel	Peripheral vessel
	Other (Specify)
	N= new indication; P= previously cleared by FDA
Other Modes				5. Angio Imaging
	1. Harmonic (Tissue or Contrast)			6. SonoCT
2. Tissue Doppler Imaging3. iScan			7. Biopsy Guidance8. Needle Visualization*
4. X-Res
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual
Previous submission: K160807 - Affiniti

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

Device name: L12-4 Transducer for use with Sparq Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)See below	Other*(Specify)
Ophthalmic	Ophthalmic	N	N	N		N		N (1, 3-6)
	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P (1, 3-6, 8)
	Intra-operative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)	P	P	P		P	P	P (1, 3-6, 8)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,3-6, 8)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3-6, 8)
	Other (Specify)
	Cardiac Adult	N	N	N		N	N	N (1,3,4,6,8)
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3-6, 8)
	Other (Specify)
	N= new indication; P= previously cleared by FDA
Other Modes						5. Angio Imaging
	1. Harmonic (Tissue or Contrast)					6. SonoCT
2. Tissue Doppler Imaging						7. Biopsy Guidance
3. iScan4. X-Res							8. Needle Visualization*
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
Previous submission: K160807 - Affiniti
Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal
	Intraoperative(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid,scrotum, prostate, breast)	P	P	P		P	P	P (1,3,4,5,7)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)	P	P	P		P	P	P (1,3,4,5,7)
	Musculo-skel (superficial)	P	P	P		P	P	P (1,3,4,5,7)
	Other (Gynecological)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Intracardiac)
	Other (Fetal)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P (1,3,4,5,7)
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
*Other modes:						5. Angio Imaging
1. Harmonics (Tissue & Contrast)						6. SonoCT
	2. Tissue Doppler Imaging					7. Biopsy guidance
	3. iSCAN						8. Infertility monitoring of follicle development
4. X-Res
Combined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
Previous submission: K123754 - CX50
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Clinical Application		Mode of Operation
General(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N (1, 3-5, 7)
	Abdominal	P	P	P	P	P	P	P (1, 3-5, 7)
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal Imaging& Other	Pediatric
	Small Organ (Scrotum,Thyroid, Breast)	N	N	N	N	N	N	N (1, 3-5, 7)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P (1, 3-5, 7)
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel(conventional)
	Musculo-skel (superficial)
	Other (Gynecological)	N	N	N	N	N	N	N (1, 3-5, 7)
	GYN
	Cardiac Adult	P	P	P	P	P	P	P (1-4)
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N	N (1, 3-5, 7)
	Other (Specify)
N= new indication; P= previously cleared by FDA
Other Modes					5. Angio Imaging
1. Harmonic (Tissue or Contrast)			6. SonoCT
2. Tissue Doppler Imaging			7. Biopsy Guidance
3. iScan4. X-Res				8. Needle Visualization*
Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

510(k) Number:

L15-7io transducer for use with Sparq Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics

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510(k) Number:

Device name: S4-2 Transducer for use with Sparq Diagnostic Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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510(k) Number:

Device name: X7-2t Transducer for use with Sparq Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track IOnly)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal/Obstetric
	Abdominal
	Intra-operative(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (thyroid, scrotum,prostate, breast)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Intra-luminal
	Musculo-skel (conventional)
	Musculo-skel (superficial)
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P (1,3,4)
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)
	N= new indication; P= previously cleared by FDA
Other Modes			5. Angio Imaging
1. Harmonic (Tissue or Contrast)			6. SonoCT
2. Tissue Doppler Imaging			7. Biopsy Guidance
3. iScan			8. Needle Visualization*
4. X-ResCombined modes: B+PWD, B+Color, B+M, B+M+Color, B+Color+PWD, B+CWD, B+Color+CWD
Previous submission: K123754 - CX50

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510(k) Summary of Safety and Effectiveness

CX50 and Sparq Diagnostic Ultrasound Systems

This summary of safety and effectiveness information is submitted in accordance with 21CFR $807.92

Date Prepared:	August 12, 2016
Manufacturer:	Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431Establishment Registration Number: 3019216
Primary ContactPerson:	Maxs NewberryRegulatory Affairs EngineerPhone: 425-482-8810Fax: 425-487-8666E-mail: maxs.newberry@philips.com
Device:	Common/usual name: Diagnostic Ultrasound System and TransducersProprietary name: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemClassification Regulation: 21CFR §892.1550, 21CFR §892.1560, 21CFR §892.1570Classification Panel: RadiologyDevice Class: Class IIPrimary Product Code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)Secondary Product Code: IYO (System Imaging Pulsed Echo, Ultrasonic)Tertiary Product Code: ITX (Transducer, Ultrasonic, Diagnostic)
Primary PredicateDevice:	Trade Name: CX50 Diagnostic Ultrasound SystemManufacturer: Philips Ultrasound, Inc.510(k) Clearance: K123754 (December 21, 2012)
Reference device (ifapplicable):	Trade Name: EPIQ 5 Diagnostic Ultrasound SystemEPIQ 7 Diagnostic Ultrasound SystemAffiniti 50 Diagnostic Ultrasound SystemAffiniti 70 Diagnostic Ultrasound System
Manufacturer:	Philips Ultrasound, Inc.
510(k) Clearance:	K160807 (April 6, 2016)
Device description:	The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation.The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel.The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application.The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm.The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes.Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.

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See Table 2 below for a comparison to the primary predicate device.

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Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
Standard	CX50	CX50 4.0	Sparq 2.0
Feature	K123754(Predicate Device)	(ModifiedDevice)	( Modified Device)
Indication forUse	Ophthalmic, Intracardiac echo,Intraoperative, Laparoscopic, Fetal,Abdominal, Pediatric, Small Organ,Adult Cephalic, Neonatal Cephalic,Trans-vaginal, Musculoskeletal,Gynecological, Cardiac Adult,Cardiac pediatric, Trans-Esophogeal.(Cardiac), Peripheral Vessel, Other(Carotid)	Same	Addition of trans-rectalindication
Transducers	• C5-1• C8-5• C9-3io• C9-3v• C10-3v• D2cwc• D5cwc• L10-4 lap• L12-3• L12-5 50• L15-7io• S5-1• S8-3• S12-4	Same with thefollowingadditionaltransducer withno newindications• S7-3tThe newtransducerintroducesneither newindications foruse nor newpatient contactmaterial.	Sparq shares thefollowing threetransducers with CX50• C5-1• L15-7io• X7-2tAnd adds the followingadditional transducers• C6-2• C9-4v• L12-4• S4-2The new transducersintroduce neither newindications for use nornew patient contactmaterial. They are usedon the currently
Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
StandardFeature	CX50K123754(Predicate Device)	CX50 4.0(ModifiedDevice)	Sparq 2.0( Modified Device)
	• X7-2t		marketed EPIQ/AffinitiDiagnostic UltrasoundSystems (K160807)
TransducerTypes	• Phased array• Linear array• Curved array• Pencil Probes• Multi-plane Transesophageal• 3D Matrix Array	Same	Same **Sparq does not have3D Matrix Arraytransducers
TransducerFrequency	1.0 – 18.0 MHz	Same	Same
Acoustic OutputDisplay & FDALimits	IEC 62359• ISPTA max=720 mw/cm2• MI max =1.9• MI display• TI display	Same	Same
Imaging Mode	• 2D Echo Imaging• M-mode Echo Imaging• PW Doppler Imaging• CW Doppler Imaging	Same	Same
Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
StandardFeature	CX50K123754(Predicate Device)	CX50 4.0(ModifiedDevice)	Sparq 2.0( Modified Device)
	2D Color Doppler Imaging Tissue Dopplwer Imaging andHarmonics (Tissue and Contrast) Combination modes
# TransmitChannels	128	Same	Same
# ReceiveChannels	256	Same	Same
510(k) Track	Track 3	Same	Same
SystemCharacteristics	Beamformer 128/128 Portable Laptop that can beplaced on mobile cart Single LCD monitor	Same	Same technology,different form factor.Sparq is cart based, withan articulating monitorarm.
Product SafetyCertification	CSA InternationalANSI/AAMI ES60601-1IEC 60601-2-37	Same	Same
EMCCompliance	IEC 60601-1-2	Same	Same
Patient ContactMaterials	All patient contact materials of theCX50 Ultrasound System andtransducers are detailed in K123754.	Same	Same
		No new patientcontactmaterials
Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
StandardFeature	CX50K123754(Predicate Device)	CX50 4.0(Modified Device)	Sparq 2.0(Modified Device)
		comparing with the predicates.	No new patient contact materials comparing with the predicates.
Accessories	Various hardcopy, recording and printing devices: report printer, DVD, USB Biopsy guides Footswitch	Same	Same

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{36}------------------------------------------------

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The modified CX50 and Sparq Diagnostic Ultrasound Systems are intended for Indications for Use: diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The devices are indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Intracardiac echo, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Trans-rectal, Musculoskeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esophogeal. (Cardiac), Peripheral Vessel, Other (Carotid).

The modified CX50 and Sparq Diagnostic Ultrasound Systems, and the predicate Technological CX50 Diagnostic Ultrasound System Cleared in K123754, are Track 3 systems characteristics: and employ the same fundamental scientific technology. They are the same in materials, type of transducers, optimization, accessories and imaging modes. The primary differences between the modified CX50 and Sparq Diagnostic Ultrasound Systems, and the predicate CX50 Diagnostic Ultrasound System (K123754), are the addition of the S7-3t transducer to CX50, and the addition of the C6-2, C9-4v (new trans-rectal indication), L12-4 and S4-2 transducers to Sparq. Each of these transducers were cleared for use with the EPIQ and Affiniti Diagnostic Ultrasound Systems in K160807. The additional trans-rectal indication for use was cleared with on the C9-4v with ClearVue (K120321).

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Summary of Non-Non-clinical performance testing has been performed on the modified CX50 and Clinical Performance Sparq Diagnostic Ultrasound Systems and demonstrates compliance with the Data: following FDA recognized consensus standards:

IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance. 2005. Amendment 1, 2012
IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General ● Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007
IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
IEC 62359. Ultrasonics Field characterization Test methods for the ● determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
ISO 10993: Biological evaluation of medical devices

The modified CX50 and Sparq Diagnostic Ultrasound Systems also comply with the FDA ultrasound specific guidance, Guidance for Industry and FDA Staff -Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.

All these tests were used to support substantial equivalence of the subject device and demonstrate that the modified CX50 and Sparq Diagnostic Ultrasound Systems:

complies with the aforementioned international and FDA-recognized ● consensus standards and FDA ultrasound guidance document, and
. meets the acceptance criteria and is adequate for its intended use.

Therefore, modified CX50 and Sparq Diagnostic Ultrasound Systems are substantially equivalent to the predicate CX50 Diagnostic Ultrasound System in terms of safety and effectiveness.

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Summary of ClinicalPerformance Data:	The modified CX50 and Sparq Diagnostic Ultrasound Systems did not requireclinical data since substantial equivalence to the primary currently marketedpredicate CX50 Diagnostic Ultrasound System and reference predicate EPIQDiagnostic Ultrasound System was demonstrated with the following attributes:• Indication for use;• Technological characteristics;• Non-clinical performance testing; and• Safety and effectiveness.
SubstantialEquivalenceConclusion:	The modified CX50 and Sparq Diagnostic Ultrasound Systems are substantiallyequivalent to the currently marketed predicate device identified above:• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems are indicated for the diagnostic ultrasonic imaging andfluid flow analysis.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems have the same gray-scale and Doppler capabilities.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems use essentially the same technologies for imaging,Doppler functions and signal processing.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems have acoustic output levels within the Track 3 FDAlimits.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems are manufactured under equivalent quality systems.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems are manufactured of materials with equivalent bio safety.There is no new material or material change in application.
	• The predicate device and the modified CX50 and Sparq DiagnosticUltrasound Systems are designed and manufactured to the same electrical andphysical safety standards.
514 PerformanceStandards	There are no Sec. 514 performance standards for the modified CX50 and Sparqsystems.

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Philips Ultrasound, Inc	Traditional 510(k)CX50 and Sparq DiagnosticUltrasound Systems	Doc. ID: 243919 ADoc. Date: August 12, 2016Page: 53 of 156
Prescription Status	The modified CX50 and Sparq Diagnostic Ultrasound Systems are prescriptiondevices. The prescription device statement appears in the labeling.
Sterilization Sites	Not applicable. No components are supplied sterile.
Track	The modified CX50 and Sparq Diagnostic Ultrasound Systems are Track 3systems.

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.