Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging technology and signal processing, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No

The device is intended for diagnostic ultrasound imaging and fluid flow analysis, for use by healthcare professionals to make a diagnosis, not for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging." The "Device Description" also mentions that the 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."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of a system console and transducers, which are hardware components. It also mentions physical knobs, buttons, a display, and system electronics.

IVD (In Vitro Diagnostic)

Based on the provided text, the Philips CX50 and Sparq Diagnostic Ultrasound Systems are not In Vitro Diagnostic (IVD) devices.

Here's why:

IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
Device Function: The text clearly states that these systems "acquire ultrasound data and to display the data in various modes of operation." They generate and receive ultrasound waves that pass through the body to create images and analyze fluid flow within the body.
Intended Use: The intended uses listed are all related to imaging and analysis of the body (e.g., Fetal, Abdominal, Cardiac, Peripheral Vessel). There is no mention of analyzing samples taken from the body.

Therefore, these devices are diagnostic imaging systems, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Intraoperative, Laparoscopic, Fetal, Abdominal, Pediatric, Small Organ (thyroid, scrotum, prostate, breast), Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal (conventional, superficial), Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-Esophogeal (Cardiac), Intracardiac echo, Peripheral Vessel, Carotid, Trans-rectal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Non-clinical performance testing has been performed on the modified CX50 and Sparq Diagnostic Ultrasound Systems and demonstrates compliance with the 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K123754

Reference Device(s)

K160807, K120321

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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

2

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)

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)

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.

3

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

"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

4

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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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)
Fetal
Imaging
& 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)
Peripheral
Vessel	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

5

	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	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
General
(Track I
Only)
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
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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

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 | | | | | | | | | |
| | 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 | | | | | | | | | |
| Fetal
Imaging
& 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) | | | | | | | | | |
| Peripheral
Vessel | 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 I
Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | 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 | | | | | | | | | |
| Fetal
Imaging
& 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) | | | | | | | | | |
| Peripheral
Vessel | 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 I
Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | 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 | | | | | | | | | |
| Fetal
Imaging
& 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) | | | | | | | | | |
| Peripheral
Vessel | 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 | | | | | | | | | |

6

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

7

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

8

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)

9

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:

(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)

10

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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	Peripheral vessel
	Other (Carotid)
	N= new indication; P= previously cleared by FDA
* Other modes:
Combined modes:
Clinical Application		Mode of Operation
General
(Track I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative
(vascular/epicardial)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	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	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
(Track I
Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal	P	P	P		P	P	P (1,3-8)
	Intraoperative
(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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:

(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)

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:

(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)

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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
Ophthalmic	Ophthalmic	P	P	P		P	P	P
(1,4,6,7)
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)
See below	Other*
(Specify)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative
(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track I
Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative
(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
General
(Track I
Only)
Ophthalmic	Ophthalmic
	Fetal/Obstetric
	Abdominal
	Intraoperative
(vascular/epicardial)
	Intraoperative (Neuro)
	Laparoscopic
Fetal
Imaging
& 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)
Peripheral
Vessel	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
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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)

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

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

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

"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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	N	N (1,3-7, 8)
	Other (Specify)
	N= new indication; P= previously cleared by FDA
Other Modes

Harmonic (Tissue or Contrast)
Tissue Doppler Imaging
iScan
X-Res | | | 5. Angio Imaging
SonoCT
Biopsy Guidance
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

25

	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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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)
Peripheral
Vessel	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	Color
Doppler	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)
Peripheral
Vessel	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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26

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:

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

27

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	Color
Doppler*	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)

Peripheral
Vessel	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

iScan | | | 7. Biopsy Guidance
Needle Visualization* | | | | | |
| 4. X-Res | | | | | | | | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | | | | | | | | |
| Previous submission: K160807 - Affiniti | | | | | | | | |

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28

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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	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
Fetal
Imaging
& 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,

| |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | 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. iScan

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 I
Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other*
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging
& 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) | | | | | | | | |
| Peripheral
Vessel | 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 | | | | | | | | | |
| (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 | | | | | | | | |
| | 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) | | | | | | | | |
| Peripheral
Vessel | 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. iScan
X-Res | | | | 8. Needle Visualization* | | | | | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual | | | | | | | | | |

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29

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

30

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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31

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 I
Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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)
Peripheral
Vessel	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-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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32

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 Hwy
Bothell, WA 98021-8431
Establishment Registration Number: 3019216
Primary Contact
Person:	Maxs Newberry
Regulatory Affairs Engineer
Phone: 425-482-8810
Fax: 425-487-8666
E-mail: maxs.newberry@philips.com
Device:	Common/usual name: Diagnostic Ultrasound System and Transducers
Proprietary name: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
Classification Regulation: 21CFR §892.1550, 21CFR §892.1560, 21CFR §892.1570
Classification Panel: Radiology
Device Class: Class II
Primary 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 Predicate
Device:	Trade Name: CX50 Diagnostic Ultrasound System
Manufacturer: Philips Ultrasound, Inc.
510(k) Clearance: K123754 (December 21, 2012)
Reference device (if
applicable):	Trade Name: EPIQ 5 Diagnostic Ultrasound System
EPIQ 7 Diagnostic Ultrasound System
Affiniti 50 Diagnostic Ultrasound System
Affiniti 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. |

33

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

34

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)	(Modified
Device)	( Modified Device)
Indication for
Use	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-rectal
indication
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 the
following
additional
transducer with
no new
indications
• S7-3t
The new
transducer
introduces
neither new
indications for
use nor new
patient contact
material.	Sparq shares the
following three
transducers with CX50
• C5-1
• L15-7io
• X7-2t
And adds the following
additional transducers
• C6-2
• C9-4v
• L12-4
• S4-2
The new transducers
introduce neither new
indications for use nor
new patient contact
material. They are used
on the currently
Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
Standard
Feature	CX50
K123754
(Predicate Device)	CX50 4.0
(Modified
Device)	Sparq 2.0
( Modified Device)
	• X7-2t		marketed EPIQ/Affiniti
Diagnostic Ultrasound
Systems (K160807)
Transducer
Types	• Phased array
• Linear array
• Curved array
• Pencil Probes
• Multi-plane Transesophageal
• 3D Matrix Array	Same	Same *
*Sparq does not have
3D Matrix Array
transducers
Transducer
Frequency	1.0 – 18.0 MHz	Same	Same
Acoustic Output
Display & FDA
Limits	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
Standard
Feature	CX50
K123754
(Predicate Device)	CX50 4.0
(Modified
Device)	Sparq 2.0
( Modified Device)
	2D Color Doppler Imaging Tissue Dopplwer Imaging and
Harmonics (Tissue and Contrast) Combination modes
# Transmit
Channels	128	Same	Same
# Receive
Channels	256	Same	Same
510(k) Track	Track 3	Same	Same
System
Characteristics	Beamformer 128/128 Portable Laptop that can be
placed on mobile cart Single LCD monitor	Same	Same technology,
different form factor.
Sparq is cart based, with
an articulating monitor
arm.
Product Safety
Certification	CSA International
ANSI/AAMI ES60601-1
IEC 60601-2-37	Same	Same
EMC
Compliance	IEC 60601-1-2	Same	Same
Patient Contact
Materials	All patient contact materials of the
CX50 Ultrasound System and
transducers are detailed in K123754.	Same	Same
		No new patient
contact
materials
Table 2. Comparison of Modified CX50 and Sparq Features to the Predicate Device
Standard
Feature	CX50
K123754
(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

35

36

37

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).

38

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.

39

| Philips Ultrasound, Inc | Traditional 510(k)
CX50 and Sparq Diagnostic
Ultrasound Systems | Doc. ID: 243919 A
Doc. Date: August 12, 2016
Page: 52 of 156 |

-------------------------	-----------------------------------------------------------------------	--------------------------------------------------------------------

| Summary of Clinical
Performance Data: | 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. | | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Substantial
Equivalence
Conclusion: | The modified CX50 and Sparq Diagnostic Ultrasound Systems are substantially
equivalent to the currently marketed predicate device identified above:
• The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound Systems are indicated for the diagnostic ultrasonic imaging and
fluid flow analysis. | | |
| | • The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound Systems have the same gray-scale and Doppler capabilities. | | |
| | • The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound Systems use essentially the same technologies for imaging,
Doppler functions and signal processing. | | |
| | • The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound Systems have acoustic output levels within the Track 3 FDA
limits. | | |
| | • The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound Systems are manufactured under equivalent quality systems. | | |
| | • The predicate device and the modified CX50 and Sparq Diagnostic
Ultrasound 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 Diagnostic
Ultrasound Systems are designed and manufactured to the same electrical and
physical safety standards. | | |
| 514 Performance
Standards | There are no Sec. 514 performance standards for the modified CX50 and Sparq
systems. | | |

40

| Philips Ultrasound, Inc | Traditional 510(k)
CX50 and Sparq Diagnostic
Ultrasound Systems | Doc. ID: 243919 A
Doc. Date: August 12, 2016
Page: 53 of 156 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Prescription Status | The modified CX50 and Sparq Diagnostic Ultrasound Systems are prescription
devices. 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 3
systems. | |