Predicate Devices

Reference Devices

K130159, K132165, K121498, K043535, K120321, K081661

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and image processing, not AI/ML capabilities.

Therapeutic

No.
The intended use and device description explicitly state that it is a "diagnostic ultrasound imaging or fluid flow analysis" and a "general purpose, software controlled, diagnostic ultrasound system." Its function is to acquire and display ultrasound data for diagnosis by healthcare professionals, not to provide therapeutic treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and "for diagnosis of patients." The "Device Description" also refers to the systems as "general purpose, software controlled, diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of both a system console (containing hardware like a display, electronics, and peripherals) and transducers, which are physical components. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this device is a "Diagnostic ultrasound imaging or fluid flow analysis of the human body". It uses ultrasound waves to create images and analyze flow within the body, not by examining samples taken from the body.
Intended Use: The intended use describes imaging and analysis of various anatomical sites within the human body.
Device Description: The description details the system console, transducers, and how ultrasound waves are generated and received to create images and analyze Doppler shifts in vivo.

The device is a diagnostic ultrasound system, which is a medical device used for imaging and analysis in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 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 user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as 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 proposed EPIQ and Affiniti 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. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Cardiac (Adult, Fetal, Pediatric), Cerebral Vascular, Cephalic (Adult, Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular, Cardiac), Musculoskeletal (Conventional, Superficial), Urology, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

Indicated Patient Age Range

Adult, Fetal, Pediatric, Neonatal.

Intended User / Care Setting

Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

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-Clinical Performance Data, Software Verification and Validation. The proposed EPIQ and Affiniti systems comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, and ISO 10993. Quality assurance measures included Risk Analysis, Product Specifications, Design Reviews, and Verification and Validation. Clinical data was not required as no new indications or features were introduced compared to the predicate device K132304.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132304

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K130159, K132165, K121498, K043535, K120321, K081661

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters.

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

April 6, 2016

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

Re: K160807 Trade/Device Name: EPIO 5 Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System Affiniti 70 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: March 22, 2016 Received: March 24, 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

1

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K160807

Device Name

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

Indications for Use (Describe)

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric,

Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-6740 EF

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510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems 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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,
8,9,10,11,12,13,15,16,17,
	Intra-operative (Cardiac)	P	P	P	P	P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13,17
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13,17
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4	Note: 5,6,8,10,12,13,14
Peripheral	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
Vessel	Cerebral vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging
Note 9: Color Power Angio (CPA)
Previous submission: K132304, EPIQ

4

510(k) No: __

3D9-3v

EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer:

System:

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	Color
Doppler**	Combined
(Spec.)	Other
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note:
5,6,8,10,11,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,
8,10,11,12,13, 15
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P
	Other: Urology	P	P	P		P
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

N= new indication; P= previously cleared (; E= previously cleared by earlier letter to file

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging
Note 9: Color Power Angio (CPA)
Previous Submission: K043535, HD 11

5

510(k) No:

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

C5-1

Transducer:

Intended Use:

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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,
9,10,11,12,13,16,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8, 910,11,12,13,
17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,,8, 9,10,11,12,13,
17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral vascular
	N= new indication P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
			Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
			Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
			Note 5: SonoCT					Note 14: TDI
			Note 6: Imaging for guidance of biopsy					Note 15: Elastography
			Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging					Note 16: ElastPQ (for Liver)
Note 17: PercuNav

	Previous submission: K132304, EPIQ
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 / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

6

510(k) No: EPIQ 5 and EPIQ 7 Ultrasound Systems System: Transducer: C8-5

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

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K132304, EPIΩ

7

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: C9-2

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

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 Imaging
& Other	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,
17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Cerebral Vascular
	N= new indication
P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
Note 5: SonoCT					Note 14: TDI
	Note 6: Imaging for guidance of biopsy				Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
	Previous submission: K132304, EPIQ
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	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,12,13,17
Fetal Imaging
& Other	Fetal / OB	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13, 15,
17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13, 15,
17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,
17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,
17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler					Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M					Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD					Note 13: XRES
Note 5: SonoCT					Note 14: TDI
Note 6: Imaging for guidance of biopsy					Note 15: Elastography
Note 7: Infertility monitoring of follicle development					Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
Previous Submission: K132304, EPIQ
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic					P
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,
8,9,10,11,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,
8,9,10,11,12,13,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
Vessel	Cerebral Vascular
	N= new indication
P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler					Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M					Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD					Note 13: XRES
	Note 5: SonoCT					Note 14: TDI
	Note 6: Imaging for guidance of biopsy					Note 15: Elastography
	Note 7: Infertility monitoring of follicle development					Note 16: ElastPQ (for Liver)
	Note 8: Panoramic Imaging					Note 17: PercuNav
	Previous Submission: K132304, EPIQ
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 / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD
	Note 13: XRES
Note 5: SonoCT					Note 14: TDI
	Note 6: Imaging for guidance of biopsy				Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
Previous Submission: K132304. EPIQ

8

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: C10-3v

9

510(k) No:

System: EPIQ 5 and EPIQ 7 Ultrasound Systems C10-4ec

Transducer: Intended Use:

10

510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

Transducer: D2cwc

11

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: D2tcd

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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)

Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular				P
	N= new indication P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler		Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
	Note 5: SonoCT	Note 14: TDI
	Note 6: Imaging for guidance of biopsy	Note 15: Elastography
	Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
	Note 8: Panoramic Imaging	Note 17: PercuNav
	Previous Submission: K132304, EPIQ

12

510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

Transducer: D5cwc

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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel				P
	Cerebral Vascular				P
	N= new indication P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography
Note 8: Panoramic Imaging	Note 16: ElastPQ (for Liver)
	Note 17: PercuNav
	Previous Submission: K132304, EPIQ
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 / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
17
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler
Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
Note 10: Harmonic Imaging
	B+M
	Note 2: Combined modes include: B+M+Color
Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
Note 12: 3D/4D Imaging
B+Amplitude+PWD
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
	B+Amplitude+CWD
Note 13: XRES
Note 5: SonoCT		Note 14: TDI
Note 6: Imaging for guidance of biopsy		Note 15: Elastography
Note 7: Infertility monitoring of follicle development		Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging		Note 17: PercuNav
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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,11,12,13,
17
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD						Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
Note 5: SonoCT	Note 6: Imaging for guidance of biopsy				Note 14: TDI
Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
	Previous Submission: K132304. EPIQ
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 / OB
	Abdominal
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,8,10,11,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler						Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M						Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color						Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD						Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD						Note 13: XRES
Note 5: SonoCT					Note 14: TDI
	Note 6: Imaging for guidance of biopsy						Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
								Previous Submission: K132304, EPIQ

13

510(k) No: System: EPIQ 5 and EPIQ 7 Ultrasound Systems Transducer: L12-3

14

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: L12-5 50

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

15

510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

Transducer: L15-7io

16

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: L18-5

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

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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K132304. EPIQ

17

510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

Transducer: S5-1

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 / OB		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 17
	Abdominal		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,
17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic		P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13, 17
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult		P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14, 17
Cardiac	Cardiac Pediatric		P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14, 17
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)		P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
Peripheral	Peripheral vessel		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,
17
Vessel	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler							Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M							Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color							Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD							Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD							Note 13: XRES
Note 5: SonoCT								Note 14: TDI
	Note 6: Imaging for guidance of biopsy							Note 15: Elastography
	Note 7: Infertility monitoring of follicle development							Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging								Note 17: PercuNav
	Previous Submission: K132304, EPIQ

18

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: S7-3t

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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M				Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD				Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
	Note 5: SonoCT				Note 14: TDI
	Note 6: Imaging for guidance of biopsy				Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
	Note 8: Panoramic Imaging				Note 17: PercuNav
Previous Submission: K132304,EPIQ

19

510(k) No: _

EPIQ 5 and EPIQ 7 Ultrasound Systems System:

Transducer: ട്ട-3

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 Imaging
& Other	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 7,8,10,11,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD					Note 13: XRES
Note 5: SonoCT					Note 14: TDI
Note 6: Imaging for guidance of biopsy					Note 15: Elastography
Note 7: Infertility monitoring of follicle development					Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav

20

510(k) No: _

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: S12-4

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 / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,10,11,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)

Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
Note 5: SonoCT					Note 14: TDI
	Note 6: Imaging for guidance of biopsy				Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
Previous Submission: K132304, EPIQ

21

510(k) No: J

System: EPIQ 5 and EPIQ 7 Ultrasound Systems V6-2

Transducer:

Intended Use:

	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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,9,10,11,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler			Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M			Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color			Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD		Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD			Note 13: XRES
Note 5: SonoCT			B+Amplitude+CWD		Note 14: TDI
	Note 6: Imaging for guidance of biopsy			Note 15: Elastography
	Note 7: Infertility monitoring of follicle development			Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging				Note 17: PercuNav
	Previous Submission: K132304, EPIQ

22

System: Transducer: Intended Use: EPIQ 5 and EPIQ 7 Ultrasound Systems VL13-5

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 / OB	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Abdominal	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Musculo-skel. (Superficial)	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13
Vessel	Cerebral Vascular	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,10,11,12,13

N= new indication; P= previously cleared

Additional Comments:

New

**Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD
Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging
Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging
Note 13: XRES

Note 14: TDI

N= new indication P= previously cleared Additional Comments:

Note 15: Elastography

23

510(k) No: _

System:

X5-1

Transducer:

Intended Use:

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 / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler					Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M					Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD						Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD						Note 13: XRES
Note 5: SonoCT						Note 14: TDI
	Note 6: Imaging for guidance of biopsy					Note 15: Elastography
	Note 7: Infertility monitoring of follicle development					Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging						Note 17: PercuNav
	Previous Submission: K132304. EPIO

24

510(k) No: J

System: EPIQ 7 Ultrasound System

X6-1

Transducer:

Intended Use:

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 / OB	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note:
6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler				Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging

Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K132304, EPIQ

25

510(k) No: _

System: EPIQ 7 Ultrasound System Transducer: X7-2 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 Imaging
& Other	Fetal / OB	N	N	N		N	Note: 1,2,3	Note: 6,7,8,10,11,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	N	N	N		N	Note: 1,2,3	Note: 6,7,8,10,11,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,13,14
	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,13,14
Peripheral
Vessel	Peripheral vessel						Note: 1,2,3
	Cerebral Vascular

N= new indication; P= previously cleared

Additional Comments:

New

**Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;
Note 2: Combined modes include: B+M+Color
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD
Note 5: SonoCT
Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging
Note 9: EFOV including Amplitude Doppler
Note 10: Harmonic Imaging
Note 11: Contrast Imaging
Note 12: 3D Imaging
Note 13: XRES
Note 14: TDI
Note 15: Elastography

26

510(k) No:

System: EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer:

X7-2t 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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
	*Color Doppler includes Color Amplitude Doppler			Note 9: Color Power Angio (CPA)
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M				Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD				Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 13: XRES
Note 5: SonoCT				Note 14: TDI
	Note 6: Imaging for guidance of biopsy				Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging						Note 17: PercuNav

Previous Submission: K132304, EPIQ

27

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

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 / OB	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	N	N	N		N	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)	N	N	N		N	Note: 1,2,3	Note: 5,8,10,11,12,13
	Intra-operative (Vascular)	N	N	N		N	Note: 1,2,3	Note: 5,8,10,11,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic	N	N	N		N	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Adult Cephalic	N	N	N		N	Note: 1,2,3	Note: 8,10,11,12,13
	Trans-rectal	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Trans-vaginal	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN	N	N	N		N		Note: 5,6,7,8,9,10,11,12,13, 15,17
	Other: Urology	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13, 15,17
	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)	N	N	N	N	N	Note: 1,2,3,4	Note: 5,6,8,10,12,13,14

Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral Vascular	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17 PercuNav

28

System:	Affiniti 70 Ultrasound System
---------	-------------------------------

C5-1

Transducer:

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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	M	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	M	P		P	Note: 1,2,3	Note: 5,6,7,8, 9,10,11,12,13,17
	Other: Urology	P	M	P		P	Note: 1,2,3	Note: 5,6,8, 9,10,11,12,13,17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral	Peripheral Vessel
Vessel	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note:17 PercuNav
Previous submission: K132304, EPIQ

29

Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:		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 / OB	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	N	N	N		N	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13,15
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8, 9,10,11,12,13
	Other: Urology	N	N	N		N	Note: 1,2,3	Note: 5,6,8, 9,10,11,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	N	N	N		N	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

Affiniti 70 and Affiniti 50 Ultrasound Systems System:

C6-2

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging

30

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 / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,11,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,11,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,11,12,13

Affiniti 70 and Affiniti 50 Ultrasound Systems System:

C8-5

Transducer:

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

E = added via Appendix E

N= new indication

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous Submission: K132304, EPIQ

31

Affiniti 70 Ultrasound System System:

Transducer:

C9-2 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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13.17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
	testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5.6,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared (K132304)

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K132304, EPIQ

32

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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,10,11,12,13, 15
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,15
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,15
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

Affiniti 70 Ultrasound System System: Transducer: C10-3v

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous Submission: K132304, EPIQ

33

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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,10,11,12,13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

Affiniti 70 and Affiniti 50 Ultrasound Systems System:

3D9-3v

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous Submission: K043535, HD 11

34

| 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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,10,11,12,13, 15
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,15
	Other: Urology	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,15
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	N	N	N		N	Note: 1,2,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

C9-4v

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K120321, ClearVue 350/550

35

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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,9,10,11,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,9,10,11,12,13,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,11,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

Affiniti 70 and Affiniti 50 Ultrasound Systems System: C10-4ec

Transducer:

E = added via Appendix E N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note:17 PercuNav
Previous submission: K132304, EPIQ

36

| 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 / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology	N	N	N		N		Note: 5,6,8,9,10,11,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

Affiniti 70 and Affiniti 50 Ultrasound Systems System: Transducer: BP10-5ec

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K081661, HD 15

37

| Intended Use: | Clinical Application | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 | | | | | | | |
| | Fetal / OB | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid,
testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | | | | | | | |
| | Other: Urology | | | | | | | |
| | Cardiac Adult | | | | P | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

Transducer: Intended Use:

D2cwc
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

38

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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic			P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

D2tcd

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

39

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 / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel			P
	Cerebral Vascular			P

Affiniti 70 and Affiniti 50 Ultrasound Systems System:

D5cwc

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

40

System: Affiniti 70 Ultrasound System

L12-3

Transducer:

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 Imaging
& Other	Fetal / OB	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

41

	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 / OB	N	N	N		N	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13
	Abdominal	N	N	N		N	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

L12-4

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K120321, ClearVue 350/550

42

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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

Transducer:

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note:17 PercuNav
Previous submission: K132304, EPIQ

43

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 / OB
	Abdominal	N	N	N		N	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,11,12,13
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

Affiniti 70 and Affiniti 50 Ultrasound Systems System: L15-7io

Transducer:

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

E = added via appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

44

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
Intended Use:	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal / OB
		Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
		Laparoscopic
		Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
		Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,11,12,13
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
		Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
		Intra-luminal
		Other: GYN
		Other: Urology
	Cardiac	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (Fetal Echo)
Peripheral		Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
Vessel		Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

L18-5

Transducer:

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

E = added via Appendix E

N= new indication

P= previously cleared (K132304)

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

45

System:	Affiniti 70 Ultrasound System
---------	-------------------------------

S5-1

Transducer:

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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
	testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13,17
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note:17 PercuNav
Previous submission: K132304, EPIQ

46

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

Transducer: S4-2

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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
	testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES	2.0
Note 5: SonoCT	Note 14: TDI	3.0
Note 6: Imaging for guidance of biopsy	Note 15: Elastography	4.0
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)	5.0
Note 8: Panoramic Imaging	6.0
Previous submission: K043535, HD11

47

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

S7-3t

Transducer:

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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

48

| Intended Use:
Clinical Application | | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 | | | | | | | | |
| | Fetal / OB | | P | P | P | | P | Note: 1,2,3 | Note: 7,8,9,10,12,13 |
| | Abdominal | | N | N | N | | N | Note: 1,2,3 | Note: 8,9,10,11,12,13 |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | | Pediatric | | P | P | P | | P | Note: 1,2,3 |
| | | Small Organ (breast, thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | | P | P | P | | P | Note: 1,2,3 | Note: 8,10,12,13 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | | | | | | | | |
| | Other: Urology | | | | | | | | |
| Cardiac | Cardiac Adult | | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 |
| | | Cardiac Pediatric | | P | P | P | P | P | Note: 1,2,3,4 |
| | | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | N | N | N | N | N | Note: 1,2,3,4 | Note: 10,11,12,13 |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | | Cerebral Vascular | | | | | | | |

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

Transducer:
Intended Use:

S8-3
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

49

Affiniti 70/50 Ultrasound System System: S12-4

Transducer:

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 Imaging
& Other	Fetal / OB
	Abdominal	N	N	N		N	Note: 1,2,3	Note: 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,9,10,11,12,13
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)

Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

50

| Intended Use:
Clinical Application | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 Imaging
& Other | Fetal / OB | P | P | P | | P | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid,
testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other: GYN | | | | | | | |
| | Other: Urology | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,2,3 | Note: 5,9,10,11,13 |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

System: Affiniti 70 and Affiniti 50 Ultrasound Systems Transducer: V6-2

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

E = added via Appendix E

N= new indication

P= previously cleared (K132304)

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

51

| 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 / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

Affiniti 70 and Affiniti 50 Ultrasound Systems System: X7-2t

Transducer:

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging
Previous submission: K132304, EPIQ

52

| Intended Use:
Clinical Application | | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (includes simultaneous B-mode) | | | | | | | |
|---------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---|-----|-----|----------|-------------|---------------------------|--|
| | | | | | | Color | Combined | | |
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Doppler* | (Spec.) | Other
(Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal / OB | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid,
testicle) | N | N | N | | N | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | | | | | | | | |
| | Other: Urology | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | | N | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |
| | Cerebral Vascular | N | N | N | | N | Note: 1,2,3 | Note: 5,6,8,9,10,11,12,13 | |

System: Affiniti 70 and Affiniti 50 Ultrasound Systems

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging (for LVO applications)
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic imaging

53

510(k) Summary of Safety and Effectiveness EPIQ 5, EPIQ 7, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems

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

1. Submitter's name, address, telephone number, contact person.

Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431

Contact person: Peng Cui, Regulatory Affairs Specialist Email: peng.cui@philips.com Tel: (978) 659-7966 Fax: (978) 487-4450

Date prepared: March 21, 2016

2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/usual name:	Diagnostic ultrasound system and transducers
Proprietary name:	EPIQ 7 Diagnostic Ultrasound System
	EPIQ 5 Diagnostic Ultrasound System
	Affiniti 50 Diagnostic Ultrasound System
	Affiniti 70 Diagnostic Ultrasound System

Within this notification,

the reference to EPIQ represents both the EPIQ 7 and the EPIQ 5,
the reference to Affiniti represents both the Affiniti 70 and the Affiniti 50. .

These devices are classified as follows:

Classification Name	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

As stated in 21 CFR, parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.

3. Substantially Equivalent Devices

Philips Ultrasound believes the proposed EPIO and Affiniti Ultrasound Systems are substantially equivalent to the following currently marketed devices:

Product	510(k)
---------	--------

54

Philips EPIQ Diagnostic Ultrasound System K132304

Below is a comparison to the predicate devices:

| Standard
Feature | EPIQ
K132304
(Predicate Device) | EPIQ 1.5
(Proposed Device) | Affiniti 1.5
( Proposed Device) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | Abdominal, Cardiac Adult,
Cardiac other (Fetal),
Cardiac Pediatric, Cerebral
Vascular, Cephalic (Adult),
Cephalic (Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial), Other:
Urology, Pediatric,
Peripheral Vessel, Small
Organ (Breast, Thyroid,
Testicle), Transesophageal
(Cardiac), Transrectal,
Transvaginal | Same | Same |
| Transducers | C5-1 C8-5 C9-2 C10-3v C10-4ec D2cwc D5cwc L12-3 L12-5 50 L15-7io L18-5 S5-1 S7-3t S8-3 S12-4 V6-2 X7-2t D2tcd X5-1 X6-1 | Same with the following
additional transducers
with no new indications VL13-5 X7-2 3D9-3v The new transducers
introduce neither new
indications for use nor
new patient contact
material. | Same with the following
additional transducers with
no new indications S4-2 3D9-3v C9-4v C6-2 BP10-5ec L12-4 VL13-5 The new transducers
introduce neither new
indications for use nor new
patient contact material.
Affiniti does not include: X5-1 X6-1 |
| Transducer | Phased array | Same | Same * |
| Standard
Feature | EPIQ
K132304
(Predicate Device) | EPIQ 1.5
(Proposed Device) | Affiniti 1.5
( Proposed Device) |
| Types | Linear array Curved array Pencil Probes Multi-plane Transesophageal Motorized arrays 3D Matrix Array | | Affiniti 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 2D Color Doppler Imaging Color Power Angio (CPA) Color Amplitude Doppler M Mode Color Doppler Imaging Broadband Imaging Harmonic Imaging 2D Tissue Doppler (TDI) Combination modes | Same | Same |
| # Transmit
Channels | 128 | Same | Same |
| # Receive
Channels | 256 | Same | Same |
| 510(k) Track | Track 3 | Same | Same |
| System
Characteristics | Beamformer 128/128 Mobile cart Single LCD monitor | Same | Same
*The Affiniti cart is smaller. Brakes are locking casters on Affiniti while EPIQ has integrated brakes and a control pedal. |
| Product Safety
Certification | CSA International | Same | Same |
| Standard
Feature | EPIQ
K132304
(Predicate Device) | EPIQ 1.5
(Proposed Device) | Affiniti 1.5
(Proposed Device) |
| EMC
Compliance | C22.2 No. 60601-1
IEC 60601-1
IEC 60601-1-2
ANSI/AAMI ES60601-1
IEC 60601-2-37 | Same | Same |
| Patient Contact
Materials | All patient contact
materials of the EPIQ
Ultrasound System and
transducers are detailed in
K132304. | Same
No new patient contact
materials comparing with
the predicates. | Same
No new patient contact
materials comparing with the
predicates. |
| Accessories | Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB PercuNav Instruments Biopsy guides Footswitch | Same | Same |

55

56

4. Device Description

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 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 user interface consists of a touch screen with soft key controls. EPIO also has a OWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as 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

57

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 proposed EPIQ and Affiniti 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. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

5. Technological Comparison to Predicate Devices

The proposed EPIQ and Affiniti ultrasound systems, and the predicate device EPIQ ultrasound system cleared in K132304 are track 3 systems and employ the same fundamental scientific technology. They are the same in indications for use, materials, type of transducers, optimization, accessories and imaging modes. The primary differences between the proposed EPIQ and Affiniti systems and the predicate device EPIO system are as follows:

Integration of OLAB Heart Model software which was cleared via K130159 and ● K132165.
. Addition of the new security features to help the healthcare providers be compliant with HIPAA and the regulations imposed by the other governmental and regulatory bodies.
. Integration of a service tool called OmniSphere. OmniSphere gives the Ultrasound system the ability to create utilization reports which describe how the system is being used. OmniSphere also allows the Biomedical Engineer within a medical facility to remotely log into a connected system to perform service related operations.
Update of the analysis packages to allow the acquisition and export of measurements and . calculations in the fetal echo DICOM template and the small parts DICOM template, to allow the standardization of user defined measurement export , and to include new or newly standardized measurements from standards bodies e.g. ASE, AIUM, ACEP.
Addition of the following transducers: VL13-5, X7-2, 3D9-3v, S4-2,C9-4v,C6-2,BP10-● 5ec,L12-4.

6. Indications for Use

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult). Cephalic (Neonatal). Fetal/Obstetric. Gynecological. Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

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

7. Safety Considerations

58

As track 3 ultrasound devices the proposed EPIQ and Affiniti Ultrasound Systems are designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.0 (Particular requirements for the basic safety and essential performance of ultrasonic medical and monitoring equipment) and IEC 62359, Ed 2.0 (Ultrasonics - Field characterization -Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields).

The proposed EPIQ and Affiniti Ultrasound Systems comply with the referenced standard as well as 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).

The system acoustic output limits are:

. Ispta.3 ≤ 720 MW/cm2
MI