Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using standard ultrasound imaging and signal processing technologies.

Therapeutic

No.
The intended use of the device is explicitly stated as "diagnostic ultrasound imaging and fluid flow analysis." The device description also highlights its function as "general purpose, software controlled, diagnostic ultrasound systems" to "acquire ultrasound data and to display the data." While it can assist in image guidance during treatment, its primary function is diagnostic, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), 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 "Device Description" also refers to them as "Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device consists of two parts: the system console and the transducers. These are hardware components, making it a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body". This involves imaging the internal structures and processes of the body directly, not analyzing samples taken from the body.
Device Description: The device description focuses on acquiring and displaying ultrasound data from the human body using transducers.
Input Imaging Modality: The input is "Diagnostic ultrasound imaging or fluid flow analysis", which are in-vivo techniques.
Anatomical Site: The listed anatomical sites are all locations within the human body.

IVD devices are specifically designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device operates by sending and receiving ultrasound waves into the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), 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.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Product codes

IYN, IYO, ITX

Device Description

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging or fluid flow analysis

Anatomical Site

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

Indicated Patient Age Range

Adult, Fetal, Neonatal, Pediatric

Intended User / Care Setting

Clinics, Hospitals, and clinical point-of-care for diagnosis of patients. Interventionalist and surgeon when integrated with Philips EchoNavigator.

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 verification testing has been performed to cover system level requirements and the risk control measures in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.
All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems:

comply with the aforementioned international and FDA-recognized consensus standards and FDA ultrasound guidance document, and
meet the acceptance criteria and are adequate for their intended use.

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems did not require clinical studies since substantial equivalence to the currently marketed predicate devices, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, was demonstrated with the following attributes:

Design features;
Indication for use;
Fundamental scientific technology;
Non-clinical performance testing; and
Safety and effectiveness.

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

Not Found

Predicate Device(s)

K172607

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

July 27, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K181485

Trade/Device Name: EPIQ , EPIQ 7, Affiniti 30, Affiniti 50 and 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: July 17, 2018 Received: July 18, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K181485

Device Name

EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, EPIQ Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

Indications for Use (Describe)

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), 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.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

CONTINUIF ON A SEPARATE PAGE IF NEEDED
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Type of Use (Select one or both, as applicable)

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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 / 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,
11,12,13,15,16,17,18,19
	Intra-operative (Cardiac)	P	P	P	P	P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-operative (Vascular)	P	P	P	P	P	Note: 1,2,3	Note: 5,8,9,10,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,12,13,17,18
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,
12,13,15,17,19
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13,17
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,12,13,17
	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	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,17
	Trans-esoph. (non-Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	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: 10,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4	Note: 5,6,8,10,12,13,14
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

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

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 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous submission: K172607, EPIQ/Affiniti

4

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: 5,6,8,10,12,13
	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, 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:
5,6,8,9,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: 3D9-3v

Transducer:

N= new indication; P= previously cleared

Additional Comments: *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 12: 3D/4D Imaging Note 2: Combined modes include: B+M+Color 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: Percu Nav Note 8: Panoramic Imaging Note 9: Color Power Angio (CPA) Previous Submission: K172607, EPIQ/Affiniti

5

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: C5-1

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	P	P	P		P	Note: 1,2,3	Note: 5,6,8,
9,10,11,12,13,16,17,18
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17,18
	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: 5,6,7,8,9,10,11,12,13,
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 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 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)

Previous submission: K172607, EPIQ/Affiniti

6

EPIQ, 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:

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: 5,6,8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	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	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	P= previously cleared
N= new indication
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: Percu Nav

Previous Submission: K172607, EPIQ/Affiniti

7

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

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
(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: 5,6,8,9,10,12,13, 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: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 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	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
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
	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:
5,6,7,8,9,10,11,12,13, 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 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
	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)
Previous Submission: K172607. ΕΡΙQ/Affiniti
Transducer: C10-4ec
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,
8,9,10,12,13,17
	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:
5,6,7,8,9,10,12,13,17
	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
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 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

Previous submission: K172607, EPIQ/Affiniti

8

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems Transducer: C10-3v

9

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

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)
Previous Submission: K172607, EPIQ/Affiniti	Note 17: PercuNav

10

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: D2cwc

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: K172607, EPIQ/Affiniti

11

System: EPIQ, 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	Cardiac Adult
	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 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: K172607, EPIQ/Affiniti

12

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

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 / 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
	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: K172607, EPIQ/Affiniti

13

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: L12-3 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	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)	P	P	P		P
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 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: 5,6,8,9,10,12,13, 17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13, 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
Vessel	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 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: K172607 ERIO/Affiniti

Note 9: Color Power Angio (CPA)

Previous Submission: K172607, EPIQ/Affiniti

14

System: EPIQ, EPIQ 5 and EPIQ 7 Ultrasound Systems

Transducer: L12-5 50

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: 5,6,8,10,12,13, 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: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	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: 5,6,8,9,10,12,13,17
	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 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: K172607. EPIQ/Affiniti

15

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:

Transducer: el18-4

s for the more of the bright of the research
Transducer:

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	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,
13,15,17,19
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,10,12,13, 17
	Small Organ (breast, thyroid,
testicle)	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,
12,13,15,17, 18,19
	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: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	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:
5,6,8,9,10,11,12,13,17
	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 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 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K172607 EPIO/Affiniti

16

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: L15-7io 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)		P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-operative (Vascular)		P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Small Organ (breast, thyroid,
testicle)		P	P	P		P	Note: 1,2,3	Note: 5,8,10,12,13
	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: 5,8,9,10,12,13
	Cerebral Vascular		P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	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

17

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: 118-5

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: 5,6,8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,12,13,15,17
	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: 5,6,8,9,10,12,13
	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
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	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: K172607, EPIQ/Affiniti

18

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

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: 6,8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic		P	P	P		P	Note: 1,2,3	Note: 8,9,10,12,13, 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: 10,12,13,14, 17
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)		P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
Peripheral
Vessel	Peripheral vessel		P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 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: K172607. EPIO/Affiniti

19

System: EPIQ, 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 / 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		Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
		Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
		Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
		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: K172607. EPIO/Affiniti

20

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: ട്ടു-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 / OB		P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric		P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	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: 10,12,13,14
Cardiac	Cardiac Pediatric		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	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: K172607, EPIQ

21

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

Transducer: S9-2

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: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note: 1,2,3	Note: 7,8,10,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	N	N	N		N	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	N	N	N	N	N	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	N	N	N	N	N	Note: 1,2,3,4	Note: 10,12,13,14
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	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 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 9: Color Power Angio (CPA)
	Note 6: Imaging for guidance of biopsy
	Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging	Note 10: Harmonic Imaging
	Note 11: Contrast Imaging
	Note 12: 3D/4D Imaging
	Note 13: XRES
	Note 14: TDI
	Note 15: Elastography
	Note 16: ElastPQ (for Liver)
	Note 17: PercuNav
	Previous Submission:

22

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:

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: 8,10,12,13
	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: 12,13,14
Cardiac	Cardiac Pediatric		P	P	P	P	P	Note: 1,2,3,4	Note: 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: K172607, EPIQ/Affiniti

23

System: EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems Transducer: V6-2 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					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(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: 5,6,8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	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: 5,9,10,13
Peripheral	Peripheral vessel
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: K172607, EPIQ/Affiniti

24

System:

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems

VL13-5 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 / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
Fetal Imaging
& Other	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
	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: 5,6,8,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13
	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: 5,6,8,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13

N= new indication; P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: EFOV including Amplitude Doppler
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 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: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging
Previous Submission: K172607, EPIQ/Affiniti

25

System: EPIQ EPIQ 5, and EPIQ 7 Ultrasound System

Transducer: X5-1

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: 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,9,10,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,12,13
	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: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
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: K172607, EPIQ/Affiniti

26

System: EPIQ EPIQ 5, and EPIQ 7 Ultrasound System

Transducer: X6-1

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
	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: ,6,8,9,10,12,13,17
	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: ,6,8,9,10,12,13
	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: 6,8,9,10,12,13,17
	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 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: K172607, EPIQ/Affiniti

27

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound System 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 / OB	P	P	P		P	Note: 1,2,3	Note: 6,7,8,10,11,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 6,7,8,10,12,13
	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 Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
Peripheral
Vessel	Peripheral vessel						Note: 1,2,3
	Cerebral Vascular

N= new indication; P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: EFOV including Amplitude Doppler
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 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: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging
Previous Submission: K172607, EPIQ/Affiniti

28

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System:

Transducer: X7-2t

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	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	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: K172607, EPIQ/Affiniti

29

EPIQ and EPIQ 7 Ultrasound System System:

Transducer: X8-2t

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		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric
	Trans-esophageal (Cardiac)		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler
	Note 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: K172607, EPIQ/Affiniti

30

EPIQ and EPIQ 7 Ultrasound System System:

Transducer: S8-3t

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 / 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, 13,14
	Trans-esophageal (Cardiac)		P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	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: K172607, EPIQ/Affiniti

31

EPIQ and EPIQ 7 Ultrasound System System: Transducer: X8-2ti 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
	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: 10,12,13,14
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	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: K172607, EPIQ/Affiniti

32

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)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	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 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: K172607, EPIQ/Affiniti

EPIQ, EPIQ 5, and EPIQ 7 Ultrasound Systems System: Transducer: XL14-3 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

33

System: Affiniti 70/50/30 Ultrasound 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)
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,3	Note: 5,8,10,11,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,3	Note: 5,8,10,11,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic	P	P	P		P	Note: 1,3	Note: 5,8,9,10,11,12,13
	Adult Cephalic	P	P	P		P	Note: 1,3	Note: 8,10,11,12,13
	Trans-rectal	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,11,12,13, 15,17
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13, 15,17
	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)	P	P	P	P	P	Note: 1,2,3,4	Note: 5,6,8,10,12,13,14
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17

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
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: K172607, EPIQ/Affiniti

34

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
(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: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,7,8,9,10,11,12,13,17
	Other: Urology	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,10,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

35

System: Affiniti 70/50/30 Ultrasound System

Transducer: C6-2

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

| Clinical Application | | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|--------------------------|--------------------------------------------|---|---|-----|-----|-------------------|----------------------|-------------------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal / OB | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 |
| | Abdominal | P | P | P | | P | Note: 1,3 | Note: 5,6, 8,9,10,11,12,13,15 |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,3 | 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 | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8, 9,10,11,12,13 |
| | Other: Urology | P | P | P | | P | Note: 1,3 | Note: 5,6,8, 9,10,11,12,13 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | | P | Note: 1,3 | Note: 5,6,10,12,13 |
| Peripheral
Vessel | Peripheral Vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

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
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: K172607, EPIQ/Affiniti

36

System: Affiniti 70/50/30 Ultrasound System

Transducer: C8-5

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	P	P	P		P	Note: 1,3	Note: 5,6,8,9,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,11,12,13
	Small Organ (breast, thyroid,
	testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,11,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,11,12,13

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
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: K172607, EPIQ/Affiniti

37

System: Affiniti 70 Ultrasound System C9-2

Transducer:

Intended Use: 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: 1,3	Note: 5,6,8,9,10,11,12,13,17
		Abdominal	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
		Laparoscopic
		Pediatric	P	P	P	P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
		Musculo-skel. (Superficial)
		Intra-luminal
		Other: GYN	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
		Other: Urology
Cardiac		Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (Fetal Echo)	P	P	P	P	Note: 1,3	Note: 5,6,10,12,13
Peripheral
Vessel		Peripheral vessel
		Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

38

System: Affiniti 70 Ultrasound System

Transducer: C10-3v

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	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	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: 1,3	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: 1,3	Note: 5,6,7,8,9,10,11,12,13,15
	Other: Urology	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

39

System: Affiniti 70/50/30 Ultrasound System

Transducer: 3D9-3v

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

Intended Use:		Mode of Operation (*includes simultaneous B-mode)
Clinical Application
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: 1,3	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: 1,3	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: 1,3	Note: 5,6,7,8,9,10,11,12,13
	Other: Urology	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

N= new indication, P= previously cleared

Additional Comments: Note 9: Color Power Angio (CPA) *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 2: Combined modes include: B+M+Color 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: K172607, EPIQ/Affiniti

40

System: Affiniti 70/50/30 Ultrasound System

Transducer: C9-4v

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

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	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,7,8,9,10,11,12,13,15
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,11,12,13,15
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	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 12: 3D/4D Imaging 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 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: K172607, EPIQ/Affiniti

41

System: Affiniti 70/50 Ultrasound System

Transducer: C10-4ec

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		P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P	P	P		P	Note: 1,3	Note: 5,6,7, 8,9,10,11,12,13,17
	Trans-vaginal		P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,7,8,9,10,11,12,13,17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)		P	P	P		P	Note: 1,3	Note: 5,6,8,10,11,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

42

System: Affiniti 70/50 Ultrasound System

Transducer: BP10-5ec

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

| 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	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,13
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology	P	P	P		P		Note: 5,6,8,9,10,11,13
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

N= new indication, P= previously cleared

Additional Comments: Note 9: Color Power Angio (CPA) *Color Doppler includes Color Amplitude Doppler Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 2: Combined modes include: B+M+Color 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: K172607, EPIQ/Affiniti

43

System: Affiniti 70/50/30 Ultrasound System

Transducer: D2cwc

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
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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

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
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: K172607, EPIQ/Affiniti

44

System: Affiniti 70/50 Ultrasound System

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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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

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
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: K172607, EPIQ/Affiniti

45

System: Affiniti 70/50 Ultrasound System

Transducer: D5cwc

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

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
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel				P
	Cerebral Vascular				P

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
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: K172607, EPIQ/Affiniti

46

System: Affiniti 70/50 Ultrasound System

Transducer: L12-3

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: 1,3	Note: 5,6,7,8,9,10,11,12,13
	Abdominal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13
	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: 1,3	Note: 5,6,8,9,10,11,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13

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
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: K172607, EPIQ/Affiniti

47

System: Affiniti 70/50/30 Ultrasound System

Transducer: L12-4

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: 1,3	Note: 5,6,7,8,9,10,11,12,13
	Abdominal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13
	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	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	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 12: 3D/4D Imaging 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 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: K172607, EPIQ/Affiniti

48

System: Affiniti 70/50/30 Ultrasound System

Transducer: L12-5 50

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

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: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17

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
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: K172607, EPIQ/Affiniti

49

System: Affiniti 70 Ultrasound System

Transducer: eL18-4

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

| 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: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17
	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: 1,3	Note: 5,6,8,9,10,11,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,17

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
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: K172607, EPIQ/Affiniti

50

System: Affiniti 70/50 Ultrasound System

Transducer: L15-7io

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.)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,3	Note: 5,8,9,10,11,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,3	Note: 5,8,9,10,11,12,13
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,11,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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: 1,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13

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
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: K172607, EPIQ/Affiniti

51

System: Affiniti 70/50 Ultrasound System

Transducer: L18-5

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

| | Clinical Application | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|---------------------------|--------------------------------------------|---|---|-----|-----|-------------------|----------------------|----------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | | | | | | | |
| | Abdominal | P | P | P | | P | Note: 1,3 | 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: 1,3 | Note: 5,6,8,9,10,11,12,13 |
| | Small Organ (breast, thyroid,
testicle) | P | P | P | | P | Note: 1,3 | 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: 1,3 | Note: 5,6,8,9,10,11,12,13 |
| | Musculo-skel. (Superficial) | P | P | P | | P | Note: 1,3 | 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 | Peripheral vessel | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |
| Vessel | Cerebral Vascular | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13 |

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
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: K172607, EPIQ/Affiniti

52

System: Affiniti 70 Ultrasound System S5-1

Transducer:

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
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,11,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
	testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,3	Note: 8,9,10,11,13,17
	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
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

53

System: Affiniti 70/50/30 Ultrasound System S4-2

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 / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,11,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,3	Note: 8,9,10,11,13
	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: 10,11,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
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 11: Contrast Imaging Note 2: Combined modes include: B+M+Color 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: K172607, EPIQ/Affiniti

54

	System: Affiniti 70/50 Ultrasound System
Transducer:
Intended Use:	S7-3t
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Clinical Application
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
	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: 10,11,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Other (Fetal Echo)
Peripheral	Peripheral vessel
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 12: 3D/4D Imaging 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 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: K172607, EPIQ/Affiniti

55

System: Affiniti 70 Ultrasound System

Transducer: 58-31

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	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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

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 Previous Submission: K172607, EPIQ/Affiniti

56

System: Affiniti 70/50/30 Ultrasound System 58-3

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 / OB	P	P	P		P	Note: 1,3	Note: 7,8,9,10,13
	Abdominal	P	P	P		P	Note: 1,3	Note: 8,9,10,11,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 8,10,11,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,3	Note: 8,10,13
	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: 10,11,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,3	Note: 10,11,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

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
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: K172607, EPIQ/Affiniti

57

System: Affiniti 70/50 Ultrasound System

Transducer:

S12-4
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| 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 | | | | | | | |
| | Abdominal | P | P | P | | P | Note: 1,3 | Note: 8,9,10,11,13 |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| | Laparoscopic | | | | | | | |
| & Other | Pediatric | P | P | P | | P | Note: 1,3 | Note: 8,9,10,11,13 |
| | Small Organ (breast, thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note: 1,3 | Note: 8,9,10,13 |
| | 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: 10,11,13,14 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| 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
Previous Submission: K172607, EPIQ/Affiniti

58

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

System: Affiniti 70/50/30 Ultrasound System

Transducer: V6-2

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

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
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: K172607, EPIQ/Affiniti

59

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	P	P	P	P	P	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

System: Affiniti 70/50 Ultrasound System

Transducer: X7-2t

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
Previous Submission: K172607, EPIQ/Affiniti

60

System: Affiniti 70 Ultrasound System

Transducer: X5-1

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
Fetal Imaging
& Other	Abdominal	P	P	P		P	Note: 1,2,3	Note: 8,9,10,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,9,10,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10,13
	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: 10,11,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
	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 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: Panoramic Imaging
	Previous Submission: K172607, EPIO

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System: Affiniti 70/50 Ultrasound System

Transducer: VL13-5

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)	P	P	P		P	Note: 1,3	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	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	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 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: K172607, EPIQ/Affiniti

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510(k) Summary of Safety and Effectiveness

EPIQ and Affiniti 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: Kym Rupp, Senior Regulatory Affairs Specialist-
Email: kym.rupp@philips.com
Tel: 425-487-7127
Fax: 425-487-8666

April 23rd, 2018 Date prepared:

1. 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 Diagnostic Ultrasound System
	EPIQ 7 Diagnostic Ultrasound System
	EPIQ 5 Diagnostic Ultrasound System
	Affiniti 70 Diagnostic Ultrasound System
	Affiniti 50 Diagnostic Ultrasound System
	Affiniti 30 Diagnostic Ultrasound System

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.

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3. Substantially Equivalent Devices

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

Predicate Device	510(k)
Philips EPIQ Diagnostic Ultrasound System and Philips
Affiniti Diagnostic Ultrasound System	K172607

4. Device Description

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). The removable transducers are connected to the system using a standard technology, multi-pin connectors.

5. Indications for Use

The intended use of the EPIQ, EPIO 5, EPIO7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the follow 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.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed. However, nothing stated in the user

64

information reduces your responsibility for sound clinical judgement and best clinical procedure.

6. Technological Comparison to Predicate Devices

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems and the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System (K172607), employ the same fundamental scientific technology. The primary differences are the addition of the S9-2 transducer to the EPIQ Diagnostic Ultrasound Systems and the extended use of ElastQ Imaging Linear (Shear Wave Elastography Imaging). The main difference between ElastO Imaging and the new ElastQ Imaging Linear is summarized below:

ElastQ Linear enables a different scanning geometry. The cleared ElastQ Imaging uses curvilinear scanning geometry while Elast() Imaging Linear uses Linear scanning geometry to allow for additional transducers to be used.
. The proposed ElastQ Imaging Linear has a higher spatial resolution which supports a stiffness range 0-200kPa (0-8.2 m/s). The cleared ElastO Imaging supports a stiffness range of 0-90kPa (0-5.5 m/s). This expanded tissue stiffness range allows for measurements of the breast in addition to the abdomen.
The proposed ElastQ Imaging Linear offers a visual comparison between ● compression elastography and Elast() Linear images, which was not available on the currently cleared ElastQ Imaging

A comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIO Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System is provided in Table 1 below:

Table 1 Comparison of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems to the currently marketed and predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System.

| Standard
Feature | EPIQ
K172607 (Predicate Device) | EPIQ 3.0
(Proposed Device) | Affiniti
K172607
(Predicate Device) | Affiniti 3.0
(Proposed
Device) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------|--------------------------------------|
| Indications
for Use | Fetal/Obstetric,
Abdominal,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Pediatric, Small Organ (Breast,
Thyroid, Testicle),
Cephalic (Neonatal),
Cephalic (Adult),
Transrectal, Transvaginal | Same as EPIQ
K172607 | Same as EPIQ
K172607 | Same as EPIQ
K172607 |

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| | Musculoskeletal (Conventional),
Musculoskeletal (Superficial)
Gynecological, Other: Urology,
Cardiac Adult,
Cardiac Pediatric,
Transesophageal (Cardiac),
Cardiac other (Fetal),
Peripheral Vessel, Cerebral
Vascular, | | | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Transducers | C5-1, C8-5, C9-2, C10-3v, C10-
4ec, D2cwc, D5cwc, eL18-4, L12-
3, L12-5 50, L15-7io, L18-5, S5-1,
S7-3t, S8-3, S8-3t, S12-4, V6-2,
X7-2t, X8-2t, D2tcd, X5-1, X6-1,
VL13-5, X7-2, X8-2ti, XL14-3,
3D9-3v | Same as EPIQ
K172607 with
addition of the S9-2
transducer. | 3D9-3v, C5-1, C6-2,
C8-5,C9-2, C9-4V,
C10-3v, C10-4ec,
D2cwc, D2tcd,
D5cwc, BP10-5ec,
eL18-4, L12-3, L12-
4, L12-5 50, L15-7io,
L18-5, S4-2, S5-1,
S7-3t, S8-3, S12-4,
V6-2, VL13-5, X7-
2t | Same as Affiniti
K172607 |
| Transducer
Types | Phased array Linear array Curved array Pencil Probes Multi-plane Transesophageal Motorized arrays 3D Matrix Array | Same as EPIQ
K172607 | Phased array Linear array Curved array Pencil Probes Multi-plane
Transesophageal Motorized
arrays | Same as Affiniti
K172607 |
| Transducer
Frequency | 1.0 - 18.0 MHz | Same | Same | Same |
| Acoustic
Output
Display &
FDA Limits | IEC 62359 ISPTA max=720 mw/cm2 MI max =1.9 MI display TI display | Same | Same | Same |
| Imaging
Mode | B mode, M mode, PWD, CWD,
Color Doppler, Combined modes, | Same | Same | Same |
| Shear wave | ElastPQ | Same | Same | Same |
| Elastography | ElastQ Imaging | Same with the
addition of ElastQ
Imaging Linear | NA | NA |
| # Transmit
Channels | 128 | Same | Same | Same |
| # Receive
Channels | 256 | Same | Same | Same |
| 510(k) Track | Track 3 | Same | Same | Same |
| Product
Safety
Certification | IEC 60601-1
C22.2 No. 60601-1
ANSI/AAMI ES60601-1
IEC 60601-2-37 | Same | Same | Same |
| EMC
Compliance | IEC 60601-1-2 | Same | Same | Same |

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| Patient
Contact

Materials	No changes from EPIQ K172607
Accessories	Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB PercuNav Instruments Biopsy guides Footswitch	Same	Same	Same

7. Safety Considerations

As a Track 3 ultrasound device, the subject EPIQ and Affiniti Diagnostic 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 subject EPIQ and Affiniti Diagnostic Ultrasound Systems comply with the referenced standard as well as the FDA ultrasound guidance document. Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on September 9, 2008.

The system acoustic output limits are:

Ispta.3 ≤ 720 MW/cm2 ●
MI