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

• K Number: K163120
• Device Name: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System
• Manufacturer: Philips Ultrasound, Inc.
• Date Cleared: 2017-01-10 ( 63 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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

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.

Predicate Devices

K160807, K112255, K142100

Reference Devices

K132304, K043535, K123754

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "general purpose, software controlled, diagnostic ultrasound system" using "essentially the same technologies for imaging, Doppler functions and signal processing" as the predicate device. There is no mention of AI/ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as "Diagnostic ultrasound imaging or fluid flow analysis" and "general purpose, software controlled, diagnostic ultrasound systems." It is used for "diagnosis of patients," not for a therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" section refers to them as "Diagnostic Ultrasound Systems" and states their purpose is to "acquire ultrasound data and to display the data in various modes of operation." The "Intended User / Care Setting" also mentions "for diagnosis of patients."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of both a system console (hardware) and transducers (hardware), in addition to the software.

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 or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to produce images or analyze flow, not a device that analyzes samples taken from the body (which is the core of IVD).
• Device Description: The description details a system console and transducers that are applied to the patient. This aligns with in-vivo imaging, not in-vitro analysis.
• Input Imaging Modality: The input is Ultrasound, which is an in-vivo imaging modality.
• Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound is applied externally or internally, not samples taken from these sites.
• Performance Studies: The performance studies described focus on acoustic output, measurement precision, transducer verification, and compliance with standards related to medical electrical equipment and biological evaluation of medical devices. These are typical for in-vivo medical devices, not IVDs which would involve studies on analytical and clinical performance using patient samples.

IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates by applying ultrasound to the body itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

Ultrasonic pulsed doppler imaging system

Anatomical Site

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.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

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

Not Found

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

Not Found

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

Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems:

• ElastQ Imaging Acoustic Output Test The purpose of this testing is to understand the thermal implications of the ElastO Imaging
• ElastQ Imaging Measurement Report A bench test of the EPIQ Diagnostic Ultrasound System in ElastQ Imaging mode in order to verify precision.
• X8-2t Transducer Verification Report To confirm X8-2t meets its specifications.
• Software Verification and Validation – Standard verification and validation testing in order to ensure the system meets specifications and use needs.
• IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
• IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007
• IEC 60601-1-6 Medical Electrical Equipment - Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability, 2010
• IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007
• ISO 10993: Biological evaluation of medical devices.
• Quality assurance measures applied to the system design and development include, but were not limited to:
  • Risk Analysis
  • Product Specifications
  • Design Reviews
  • Verification and Validation

The proposed EPIQ and Affiniti Diagnostic Ultrasound Systems did not require clinical study, since substantial equivalence to the currently marketed predicate devices, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System and SuperSonic AIXPLORER with ShearWave™ Elastography, respectively, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160807, K112255, K142100

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

K132304, K043535, K123754

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

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

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

January 10, 2017

Philips Ultrasound, Inc. % Ms. Peng Cui Senior Regulatory Specialist 3000 Minuteman Road ANDOVER MA 01810

Re: K163120

Trade/Device Name: EPIO 5 Diagnostic Ultrasound System: EPIO 7 Diagnostic Ultrasound System: Affiniti 50 Diagnostic Ultrasound System: Affiniti 70 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 8, 2016 Received: November 9, 2016

Dear Ms. Cui:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael O'Hara

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K163120 Device Name

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

Indications for Use (Describe)

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

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

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 70 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

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EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,
8,9,10,11,12,13,15,16,17,18
	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	Laparoscopic
& Other	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
	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
	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	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	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11 ,12,13,17
Vessel	Cerebral vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 11,12,13,17

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)
Previous submission: K132304, K160807, EPIQ

510(k) No:

4

510(k) No: ___

| System:
Transducer: | EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
3D9-3v | | | | | | | | |
|---------------------------|------------------------------------------------------------------------------------|---------------------------------------------------|---|-----|-----|--------------------|---------------------|---------------------------------|--|
| 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
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid,
testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | P | P | P | | P | Note: 1,2,3 | Note: 5,6,7,
8,10,,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
Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral Vascular | | | | | | | | |

ERIC-5 LERIC-7.R' (6-11)

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

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

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

5

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

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 Imaging
& Other	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)
	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, 910,11 ,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
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
*Color Doppler includes Color Amplitude Doppler			Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD: B+Color: B+Amplitude:

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous submission: K132304, EPIQ	Note 18: ElastQ Imaging

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510(k) No:

Note 8: Panoramic Imaging

Previous Submission: K132304, EPIQ

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: Intended Use:

C8-2 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
	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	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	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13
Vessel	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;				Note 10: Harmonic Imaging
B+M
Note 2: Combined modes include: B+M+Color					Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
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)
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13, 17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13, 17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral	Peripheral vessel	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 6: Imaging for guidance of biopsy				Note 14: TDI
	Note 7: Infertility monitoring of follicle development				Note 15: Elastography
Note 8: Panoramic Imaging					Note 16: ElastPQ (for Liver)
Note 17: PercuNav
	Previous submission: K132304, EPIQ
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	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,
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 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 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: K132304, EPIQ					Note 17: PercuNav
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	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;				Note 10: Harmonic Imaging

Note 17: Percu Nav

7

510(k) No: System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems Transducer: C9-2

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

8

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System: Transducer: C10-3v

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

9

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System: Transducer: C10-4ec Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

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

10

510(k) No: _______________________________________________
System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
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
	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 6: Imaging for guidance of biopsy					Note 14: TDI
Note 15: Elastography
	Note 7: Infertility monitoring of follicle development				Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging					Note 17: PercuNav
Previous Submission: K132304, EPIQ

11

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: D2tcd

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

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

12

510(k) No:

System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

Transducer: D5cwc

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

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

13

510(k) No: System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

Transducer: L12-3

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

14

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems Svstem: Transducer: L12-5 50 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

B+Amplitude+CWD

Note 6: Imaging for guidance of biopsy

Previous Submission: K132304, EPIQ

Note 8: Panoramic Imaging

Note 7: Infertility monitoring of follicle development

Note 5: SonoCT

Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific Color Combined Other B M PWD CWD (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic P Fetal / OB P P Note: 5,6,8,9,10,12,13 P Note: 1,2,3 Abdominal Note: P P P P Note: 1,2,3 5,6,8,9,10,11,12,13,15,17 Intra-operative (Cardiac) Intra-operative (Vascular) Fetal Imaging Laparoscopic & Other Pediatric P P P P Note: 1,2,3 Note: 5,6,8,10, 12,13, 17 Small Organ (breast, thyroid, Note: P P P P Note: 1,2,3 5,6,8,9,10,11,12,13,15,17 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, 12,13,17 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) P P Peripheral Peripheral vessel P P Note: 1,2,3 Note: 5,6,8,9,10, 12,13,17 P Vessel Cerebral Vascular 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; Note 10: Harmonic Imaging B+M Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging Note 3: Combined modes include: B+Color+PWD; Note 12: 3D/4D Imaging B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 13: XRES

Note 14: TDI

Note 15: Elastography

Note 17: PercuNav

Note 16: ElastPQ (for Liver)

Page 13 of 52

15

510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic 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 Imaging
& Other	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
	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	Cardiac Adult
	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

16

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: L18-5

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 Imaging
& Other	Fetal / OB	P	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)
		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	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,,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

17

510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: 55-1

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 Imaging
& Other	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)
	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	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14, 17
	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; Note 10: Harmonic Imaging
B+M
Note 2: Combined modes include: B+M+Color Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD; Note 12: 3D/4D Imaging
B+Amplitude+PWD
Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 13: XRES
B+Amplitude+CWD
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

18

510(k) No: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System: Transducer: S7-3t

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,,12,13,14
Cardiac	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: K132304 EPIQ

19

510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: 58-3

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	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;				Note 10: Harmonic Imaging
B+M	Note 2: Combined modes include: B+M+Color				Note 11: Contrast Imaging
	Note 3: Combined modes include: B+Color+PWD;
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: K132304, EPIQ

20

510(k) No: System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems Transducer: S12-4

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
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	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	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)
B+M	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;						Note 10: Harmonic Imaging
	Note 2: Combined modes include: B+M+Color						Note 11: Contrast Imaging
		Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 12: 3D/4D Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD						Note 13: XRES
Note 5: SonoCT							Note 14: TDI
	Note 6: Imaging for guidance of biopsy						Note 15: Elastography
	Note 7: Infertility monitoring of follicle development						Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging							Note 17: PercuNav
							Previous Submission: K132304. EPIQ

21

510(k) No: System: Transducer:

Previous Submission: K132304, EPIQ

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

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

22

System:	EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
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
r**	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Abdominal	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	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
	Small Organ (breast, thyroid,
testicle)	P	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	P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Musculo-skel. (Superficial)	P	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	P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Cerebral Vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,10,,12,13

N= new indication; P= previously cleared

Additional Comments:

• New

**Color Doppler includes Color Amplitude Doppler

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

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

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

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

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Note 14: TDI

Note 15: Elastography

23

510(k) No: System: Transducer: Intended Use:

Note 8: Panoramic Imaging

Previous Submission: K132304, EPIQ

EPIQ 7 Diagnostic Ultrasound Systems

X5-1

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	P	P	P		P		Note: 8,9,10,,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	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	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)
	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 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 17: Percu Nav

24

510(k) No: System: Transducer: Intended Use:

EPIQ 7 Diagnostic Ultrasound Systems

X6-1

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.)
Clinical Application	Clinical Application
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: ,6,8,9,10,12,13
	Abdominal	P	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	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
N= new indication
Additional Comments:	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 1: Combined modes include: B+PWD; B+Color; B+Amplitude;

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

25

| EPIQ 7 Diagnostic Ultrasound Systems
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
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 6,7,8,10,,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 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	Note: 1,2,3,4	Note: 10,,13,14
Cardiac	Cardiac Pediatric	P	P	P		P	Note: 1,2,3,4	Note: 10,,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	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

510(k) No:

Additional Comments:

• New

**Color Doppler includes Color Amplitude Doppler

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

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

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

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

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Note 14: TDI

Note 15: Elastography

26

510(k) No: System: Transducer:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

X7-2t

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(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 14: TDI

Note 15: Elastography

Note 16: ElastPQ (for Liver) Note 17: Percu Nav

Note 6: Imaging for guidance of biopsy Note 7: Infertility monitoring of follicle development Note 8: Panoramic Imaging Previous Submission: K132304, EPIQ

No

No No No

Note 5: SonoCT

27

510(k) No: System: Transducer: Intended Use:

Previous Submission: K123754 CX50 System

EPIQ 7 Diagnostic Ultrasound Systems

X8-2t

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

Clinical Application				Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	N	N	N	N	N	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)	N	N	N	N	N	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

28

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: 5,6,7,8,9,10,12,13,17
	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: 5,8,10,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,3	Note: 5,8,10,12,13
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	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: 5,8,9,10,12,13
	Adult Cephalic	P	P	P		P	Note: 1,3	Note: 8,10,12,13
	Trans-rectal	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal
	Other: GYN	P	P	P		P		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	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: 1,3	Note: 5,6,8,9,10,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17

Affiniti 70/50 Diagnostic Ultrasound Systems System:

E = added via Appendix E, 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: K160807, Affiniti system

29

System:	Affiniti 70 Diagnostic Ultrasound Systems
Transducer:	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 Imaging
& Other	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)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	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)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13,17
	Other: Urology	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,10,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

E = added via Appendix E, 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: K160807, Affiniti system

30

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic
	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: 5,6,8,9,10,11,12,13,1
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,10,12,13
Peripheral	Peripheral Vessel
Vessel	Cerebral Vascular

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication,P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

31

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 Imaging
& Other	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

32

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(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: 5,6,8,9,10,12,13,17
	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: 5,6,8,9,10,12,13,17
	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: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Other: Urology
	Cardiac Adult
Cardiac	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

System: Affiniti 70 Diagnostic Ultrasound Systems Transducer: C9-2

E = added via Appendix E

N= new indication

P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

33

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	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, 8,10,12,13, 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: 5,6,7,8,9,10,12,13,15
	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

Affiniti 70 Diagnostic Ultrasound Systems System:

C10-3v

Transducer:

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

E = added via Appendix E, N= new indication. P= previously cleared

Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 10: Harmonic Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M 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 13: XRES Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 5: SonoCT Note 14: TDI Note 15: Elastography Note 6: Imaging for guidance of biopsy Note 7: Infertility monitoring of follicle development Note 16: ElastPQ (for Liver) Note 8: Panoramic Imaging Previous Submission: K160807, Affiniti system

34

| Transducer:
Intended Use: | 3D9-3v
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 | |
| | 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, 8,10,12,13 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | |
| | Other: Urology | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | |
| | 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 | Peripheral vessel | | | | | | | | |
| Vessel | Cerebral Vascular | | | | | | | | |

Affiniti 70/50 Diagnostic Ultrasound Systems System:

E = added via Appendix E, N= new indication, P= previously cleared

Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 9: Color Power Angio (CPA) Note 10: Harmonic Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M 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: K160807, Affiniti system

35

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
	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, 8,10,12,13, 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: 5,6,7,8,9,10,12,13,15
	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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

N= new indication P= previously cleared

E = added via Appendix E

*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: K160807, Affiniti system

36

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: 5,6,8,9,10,12,13,17
	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: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,3	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
	Other: Urology	P	P	P		P	Note: 1,3	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: 1,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

37

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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

BP10-5ec

Transducer:

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

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

38

Transducer:	D2cwc
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	Cardiac Adult				P
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

Affiniti 70/50 Diagnostic Ultrasound Systems Transducer: D2cwc

System:

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 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: K160807, Affiniti system

39

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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

40

Transducer:	D5cwc
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	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
Vessel	Cerebral Vascular				P

System:
Transducer: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

41

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

Affiniti 70 Diagnostic Ultrasound Systems System:

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: K160807, Affiniti system

42

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
	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	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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: 5,6,8,9,10,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

Affiniti 70/50 Diagnostic Ultrasound Systems System:

Transducer: L12-4

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: K160807, Affiniti system

43

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, 8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	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: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	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	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17

Affiniti 70/50 Diagnostic Ultrasound Systems System:

L12-5 50

Transducer:

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: K160807, Affiniti system

44

| Transducer:
Intended Use: | L15-7io
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, 8,9,10,12,13 | |
| | Intra-operative (Cardiac) | P | P | P | | P | Note: 1,3 | Note: 5,8,9,10,12,13 | |
| | Intra-operative (Vascular) | P | P | P | | P | Note: 1,3 | Note: 5,8,9,10,12,13 | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 | |
| | Small Organ (breast, thyroid,
testicle) | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,12,13 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | P | P | P | | P | Note: 1,3 | 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 Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,12,13 | |
| | Cerebral Vascular | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,12,13 | |

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via appendix E,N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

45

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, 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	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: 1,3	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

Affiniti 70/50 Diagnostic Ultrasound Systems System:

Transducer: 118-5

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: K160807, Affiniti system

46

	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, 8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,3	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
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
	E = added via Appendix E, 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

System: Affiniti 70 Diagnostic Ultrasound Systems

47

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, 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,3	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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

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: K160807, Affiniti system

48

System: Ammifu 70/50 Diagnostic Ultrasound Systems
Transducer: S7-3t
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	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

Affiniti 70/50 Diagnostic Ultrasound Systems System:

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: K160807, Affiniti system

49

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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

Transducer:

58-3

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

E = added via Appendix E,N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

50

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

Affiniti 70/50 Diagnostic Ultrasound Systems System:

S12-4

Transducer:

alvsis of the huma ded Ue ... ત્વામાં .. ાંત્વે મા Intr Di

E = added via Appendix E, 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; Note 13: XRES B+Amplitude+CWD 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: K160807, Affiniti system

51

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: 5,6,8,9,10,12,13
	Abdominal
Fetal Imaging
& Other	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)	P	P	P		P	Note: 1,3	Note: 5,9,10,13
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E,N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

52

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	E	E	E	E	E	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

System: Affiniti 70/50 Diagnostic Ultrasound Systems

E = added via Appendix E, N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
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: K160807, Affiniti system

53

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

System: Affiniti 70/50 Diagnostic Ultrasound Systems

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: K160807, Affiniti system

54

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: Peng Cui, Regulatory Affairs Specialist Email: [e-mail] Tel: [phone] Fax: [phone]

Date prepared: November 7, 2016

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

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

3. Substantially Equivalent Devices

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

Product		510(k)
Philips EPIQ Diagnostic Ultrasound
System and Philips Affiniti Diagnostic	Primary Predicate
Device	K160807

55

Ultrasound System
SuperSonic AIXPLORER with
ShearWave™ Elastography	Predicate Device	K112255, K142100

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

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

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

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 (K160807), employ the same fundamental scientific technology. The primary difference is the addition of the ElastQ Imaging and the new transducer X8-2t to the EPIQ system. The ElastQ Imaging is a quantitative elastography technique for tissue stiffness measurement. Note that the ElastQ imaging utilizes the same fundamental scientific techonology as provided with the predicate device, SuperSonic AIXPLORER with ShearWave™ Elastography (K112255, K142100). The X8-2t transducer is a derivative of the cleared and marketed X7-2t cleared for use with the currently marketed and predicate device. Philips EPIO Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System transducer (K160807). The new transducer X8-2t is made from the same material and is provided with an additional button installed on the handle, for ease of use. Its frame rate has been increased to improve imaging quality and workflow has been improved. The new X8-2t transducer does not introduce new indications for use.

56

A 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, and SuperSonic AIXPLORER with ShearWave™ Elastography 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, and and SuperSonic AIXPLORER with ShearWave™ Elastography
Standard
Feature	SuperSonic
AIXPLORER with
ShearWave™
Elastography,
K112255, K142100
(Predicate device)	EPIQ
K160807, K132304
(Primary Predicate Device)	EPIQ 1.7
(Proposed Device)	Affiniti 1.7
K160807
(Primary
Predicate Device)	Affiniti 1.7
(Proposed
Device)
Indications
for Use	Abdominal, Small
organs,
Musculoskelatal,
Superficial
Musculoskeletal,
Vascular, Peripheral
Vascular,
Intraoperative,
OB-GYN, Pelvic,
Pediatric, Urology,
Trans-rectal, Trans-
vaginal and
Neonatal/adult
Cephalic.	Fetal/Obstetric,
Abdominal,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Pediatric, Small Organ
(Breast, Thyroid, Testicle),
Cephalic (Neonatal),
Cephalic (Adult),
Transrectal, Transvaginal
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial)
Gynecological, Other:
Urology, Cardiac Adult,
Cardiac Pediatric,
Transesophageal (Cardiac),
Cardiac other (Fetal),
Peripheral Vessel, Cerebral
Vascular,	Same as EPIQ
K160807	Same as EPIQ
K160807	Same as EPIQ
K160807
Transducers		C5-1, C8-5, C9-2,C10-3v,
C10-4ec, D2cwc, D5cwc,
L12-3,L12-5 50, L15-7io,
L18-5, S5-1, S7-3t, S8-3,
S12-4, V6-2, X7-2t, D2tcd,
X5-1, X6-1, VL13-5,X7-2 ,
3D9-3v	Same as EPIQ
K160807 with
addition of X8-2t	3D9-3v, C5-1, C6-
2, C8-5,C9-2, C9-
4V, C10-3v, C10-
4ec, D2cwc,
D2tcd, D5cwc,
BP10-5ec, L12-3,
L12-4,L12-5,L15-
7io, L18-5, S4-2,
S5-1, S7-3t, S8-3,
S12-4, V6-2,
VL13-5, X7-2t	Same as
Affiniti
K160807
Transducer
Types		Phased array Linear array Curved array Pencil Probes Multi-plane
Transesophageal Motorized arrays 3D Matrix Array	Same as EPIQ
K160807	Phased array Linear array Curved array Pencil Probes Multi-plane
Transesophag
eal Motorized
arrays	Same as
Affiniti
K160807
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, and and SuperSonic AIXPLORER with ShearWave™ Elastography
Standard
Feature	SuperSonic
AIXPLORER with
Shear Wave ™
Elastography,
K112255, K142100
(Predicate device)	EPIQ
K160807, K132304
(Primary Predicate Device)	EPIQ 1.7
(Proposed Device)	Affiniti 1.7
K160807
(Primary
Predicate Device)	Affiniti 1.7
(Proposed
Device)
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, Color Doppler,
Combined modes,	B mode, M mode, PWD,
CWD, Color Doppler,
Combined modes,	Same	Same	Same
Shear wave		ElastPQ	Same	Same	Same
Elastography	ShearWave™
Elastography	NA	ElastQ Imaging
*ElastQ imaging is
similar to
ShearWave™
Elastography
(K112255, K142100)	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		CSA International	Same	Same	Same
EMC
Compliance		C22.2 No. 60601-1
IEC 60601-1
IEC 60601-1-2
ANSI/AAMI ES60601-1
IEC 60601-2-37	Same	Same	Same
Patient
Contact
Materials		No changes from EPIQ K160807
Accessories		• Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB
• PercuNav Instruments
• Biopsy guides	Same	Same	Same

57

58

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 EPIO 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