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

• K Number: K172607
• Device Name: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
• Manufacturer: Philips Healthcare
• Date Cleared: 2017-10-04 ( 35 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: 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. When Philips EPIQ system is integrated with Philips EchoNavigator. the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

Device Description

The proposed EPIO 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, multipin connectors.

Predicate Devices

K163120, K121781

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose diagnostic ultrasound system and does not mention AI, ML, or related terms in the device description, intended use, or performance studies.

Therapeutic

No.
The device is described as a "diagnostic ultrasound imaging and fluid flow analysis" system, indicating its purpose is for diagnosis, not treatment. While it can "assist the interventionalist and surgeon with image guidance during treatment," its primary function remains diagnostic imaging to guide the treatment, not to perform the treatment itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the system is for "diagnostic ultrasound imaging and fluid flow analysis." The "Device Description" also clearly labels the systems as "Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body". This describes an in-vivo (within the living body) diagnostic method, not an in-vitro (outside the living body) diagnostic method.
• Device Description: The description details a system console and transducers that acquire and display ultrasound data from the human body. This aligns with in-vivo imaging.
• Input Imaging Modality: The input modality is "Diagnostic ultrasound," which is an in-vivo imaging technique.
• Anatomical Site: The listed anatomical sites are all parts of the human body, indicating in-vivo application.
• Performance Studies: The performance studies focus on safety and effectiveness in the context of medical electrical equipment and ultrasound systems, not on the performance of tests on biological samples outside the body.

IVD devices are designed to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide diagnostic information. This device operates by sending and receiving ultrasound waves within the body to create images and analyze fluid flow.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the EPIQ series, Affiniti 30 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiat Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obsteric, Gynecological, Intraoperative (Cardiac), Intraoperat Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardisvascular disease in which the X-ray and live Echo Guidance. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed.

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

IYN, IYO, ITX

Device Description

The proposed EPIO 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, multipin connectors.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The clinical environments where the EPIQ system 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)

Nonclinical performance testing was performed to demonstrate substantial equivalence to predicate devices. This testing included compliance with electrical safety, EMC, usability, and specific ultrasound standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62359, ISO 10993). Clinical studies were not required. The device passed all required nonclinical testing and is substantially equivalent to predicate devices for 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.

K163120, K121781

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.

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.

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

October 4, 2017

PHILIPS HEALTHCARE C/O Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW Buffalo MN 55313

Re: K172607

Trade/Device Name: Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 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: August 28, 2017 Received: August 30, 2017

Dear Mr. Job:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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 D. O'Hara For

Robert Ochs 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 | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known)
K172607 | |
| Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System
Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Device Name | |
| The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and
fluid flow analysis of the human body with the following Indications for Use:
Indications for Use (Describe) | |
| Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiat Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obsteric, Gynecological, Intraoperative (Cardiac), Intraoperat
Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast,
Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal | |
| The clinical environments where the EPIQ system can be used include Clinics, Hospitals, and clinical point-of-care for
diagnosis of patients. | |
| guidance during treatment of cardisvascular disease in which the X-ray and live Echo Guidance
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image | |
| instructions given in the product user information, and only for the purposes for which it was designed. However, nothing
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating
stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure. | |
| | |
| | |
| | |
| > Prescription Use (Part 21 CFR 801 Subpart D)
or both, as applicable)
Type of Use (Select one | _ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995 | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and completer aspect
of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services
Paperwork Reduction Act (PRA) Staff
Office of Chief Information Officer
Food and Drug Administration
[e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number." | |
| Page 1 of 1
FORM FDA 3881 (7/17) | EF
PSC Publishing Services [phone] |

As

ﺭﺱ ﺍﻟ

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5 10(k) No: _______________________________________

System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
Intended Use:

Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; br 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; br B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; br 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: K163120 EPIQ/Affiniti

4

510(k) No:

Note: Note: 5,6,8,10,,12,1 Note: 5,6,7,
8,10,,12,13, 15 Other
(Spec.) Note: 1,2,3 Note: 1,2,3 Note: 1,2,3 an A y and L. Fat - Bragnotic Official of Colorno
SD9-37 Storio ultrasound in the More of the human body as follows:
Diagnosic ultrasound imaging or finales of Operation ("Mo d d d d EPIQ 5 and EPIQ 7 Diagnostic Ultrasound System d d d d പ d d d d d d പ്ര
പ Small Organ (breast, thyroid Intra-operative (Cardiac)
Intra-operative (Vascular) Neonatal Cephalic
Adult Cephaliic
Trans-rectal
Trans-rectal
Trans-vaginal Cerebral Vascular Peripheral vessel Specific
(Tracks I & III) aparoscopic Ophthalmic Abdominal Fetal / OB Pediatric testicle) Clinical Application System:
Transducer:
Intended Use: Fetal Imaging
& Other General
(Track | only)
Ophthalmic Peripheral Cardiac Vessel

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

Additional Comments

*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging	Note 9: Color Power Angio (CPA)	Previous Submission: K163120 EPIQ/Affiniti
Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D/4D Imaging	Note 13: XRES	Note 14: TDI	Note 15: Elastography	Note 16: ElastPQ (for Liver)	Note 17: PercuNav

5

510(k) No: ___________________________________________________________________________________________________________________________________________________________________

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

	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,
9,10,11,12,13,16,17,18
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
,12,13,17,18
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8, 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

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: K163120 EPIQ/Affiniti	Note 18: ElastQ Imaging

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510(k) No: ___________________________________________________________________________________________________________________________________________________________________ C8-5 Intended Use: Transducer:

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	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic					P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic	P	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,12,13

Note 11: Contrast Imaging

Note 12: 3D/4D Imaging

Note 13: XRES Note 14: TDI

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

B+Amplitude+CWD

Note 5: SonoCT

Note 2: Combined modes include: B+M+Color
Note 3: Combined modes include: B+Color+PWD;
Note 3: Combined modes include: B+Color+PWD;

Note 7: Infertility monitoring of follicle development

Note 6: Imaging for guidance of biopsy

Previous Submission: K163120 EPIQ/Affiniti

Note 8: Panoramic Imaging

Note 16: ElastPQ (for Liver)

Note 15: Elastography Note 17: Percu Nav

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 510(k) No: ___________________________________________________________________________________________________________________________________________________________________ Transducer:
Intended Use:

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

Note 11: Contrast Imaging

Note 12: 3D/4D Imaging

Note 13: XRES Note 14: TDI

---

Note 5: SonoCT

Note 3: Combined modes include: B+Color+PWD; Note 2: Combined modes include: B+M+Color

Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous submission: K163120 EPIQ/Affiniti

Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

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510(k) No:
System:	EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
Transducer:	C10-3v
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Note 9: Color Power Angio (CPA)	Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D/4D Imaging	Note 13: XRES	Note 14: TDI	Note 15: Elastography	Note 16: ElastPQ (for Liver)	Note 17: PercuNav
Additional Comments:	*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging	Previous Submission: K163120 EPIQ/Affiniti

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510(k) No: ___________________________________________________________________________________________________________________________________________________________________

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

	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
Fetal Imaging
& Other	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,11,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Trans-vaginal	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
	Other: Urology	P		P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P			Note: 1,2,3	Note: 5,8,9,10,
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13, 17
	Cerebral Vascular
	N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 9: Color Power Angio (CPA)

Note 9: Color Power Angio (CPA)	Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D/4D Imaging	Note 13: XRES	Note 14: TDI	Note 15: Elastography	Note 16: ElastPQ (for Liver)	Note 17: PercuNav
*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging
Intended Use:	Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult			P
	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 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 12: 3D/4D Imaging
Note 5: SonoCT Note 13: XRES
Note 6: Imaging for guidance of biopsy Note 14: TDI
Note 7: Infertility monitoring of follicle development Note 15: Elastography
Note 8: Panoramic Imaging Note 16: ElastPQ (for Liver)
Previous Submission: K163120 EPIQ/Affiniti Note 17: PercuNav

Previous Submission: K163120 EPIQ/Affini

10

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

11

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

| Transducer:
Intended Use: | Clinical Application | Mode of Operation (includes simultaneous B-mode) | | | | | | Other
(Spec.) | | |
|------------------------------|--------------------------|---------------------------------------------------|-----------------------------------------|---|---|-----|-----|------------------|-------------------|----------------------|
| | | General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | | Color
Doppler | Combined*
(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 | | | P | | | | |
| | | | Cerebral Vascular | | | | | | | |

| Cerebral Vascular
N= new indication

Additional Comments:

Note 9: Color Power Angio (CPA)	Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D/4D Imaging	Note 13: XRES	Note 14: TDI	Note 15: Elastography	Note 16: ElastPQ (for Liver)	Note 17: PercuNav
*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging
Previous Submission: K163120 EPIQ/Affiniti

12

Dow -510(k) No: ___________________________________________________________________________________________________________________________________________________________________ Intended Use:

| General
(Track I only) | Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|-----------------------------------------------------------------|------------------------------------------------------|---|---|-----|-----|-------------------|----------------------|--------------------------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging
& 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 | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | P |
| | Cerebral Vascular | | | | | | | P |
| Clinical Application | Mode of Operation (includes simultaneous B-mode) | | | | | | | |
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13, 17 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12, 13, 17 |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid, testicle) | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13, 17 |
| | Neonatal Cephalic | P | 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 | P | Note: 1,2,3 | Note: 5,6,8,9,10,, 12, 13,
17 |
| | Musculo-skel. (Superficial) | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10, 12,13, 17 |
| | Intra-luminal | | | | | | | |
| | Other: GYN | | | | | | | |
| | Other: Urology | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9, 10, 11, 12, 13,
17 |
| | Cerebral Vascular | P | P | P | P | P | Note: 1,2,3 | Note: 5,6,8,9,10,11 12,13 |
| N= new indication P= previously cleared
Additional Comments: | | | | | | | | |

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

13

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

14

ed 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	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10, 12,13, 17
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	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, 12,13,17
	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 9: Color Doppler includes Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography
Note 8: Panoramic Imaging	Note 16: ElastPQ (for Liver)
Previous Submission: K163120 EPIQ/Affiniti	Note 17: PercuNav

15

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,8,10,,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	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
Previous Submission: K163120 EPIQ/Affiniti

16

diagnostic ultrasound indications for use statement

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

Lucer-
el84
diameter

1. diameter
2. internal
3. internal
4. diameter

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

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: K163130 EBIO/Affiniti

17

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,, 12, 13
	Pediatric	P	P	P		P	Note: 1,2,3
	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

*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: K163120 ERIO/Affiniti

18

ed 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	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 17
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	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)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Cerebral Vascular

*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M
Note 2: Combined modes include: B+M+Color
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD
Note 5: SonoCT
Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Note 9: Color Power Angio (CPA)
Note 10: Harmonic Imaging
Note 11: Contrast Imaging
Note 12: 3D/4D Imaging
Note 13: XRES
Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PercuNav
Previous Submission: K162120 ERIO/Affiniti

19

510(k) No: ___________________________________________________________
System:

	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,,12,13,14
	Cardiac Pediatric	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	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD: B+Color: B+Amplitude:
Note 9: Color Power Angio (CPA)

*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

hote 15: Elastography
Note 16: ElastPQ (for Liver)
Note 16: ElastPQ (for Liver)
Note 17: PercuNav Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: K.I.63120 EPIQ/Affiniti

20

38-3 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
Fetal Imaging
& Other	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	Cardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4
Note: 1,2,3,4	Note: 10,,12,13,14
Note: 10,,12,13,14

P= previously cleared ral

Peripheral
Vessel

Additional Comments:

Note 9: Color Power Angio (CPA)	Note 10: Harmonic Imaging	Note 11: Contrast Imaging	Note 12: 3D/4D Imaging	Note 13: XRES	Note 14: TDI	Note 15: Elastography	Note 16: ElastPQ (for Liver)	Note 17: PercuNav
*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging
Previous Submission: K163120 ERIO/Affiniti

21

ed 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	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	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: ,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: ,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
N= new indication P= previously cleared
Additional Comments:

Additional Comments:
Color, Dome: Includes Color, Amplitude, Doppler

*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: K163120 EPIQ/Affiniti

22

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

v6-2
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:						Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Clinical Application
Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 12, 13
	Abdominal	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 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	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 1: Combined modes include: B+PWD; B+Color; B+Amplitude;					Note 9: Color Power Angio (CPA)
B+M	Note 2: Combined modes include: B+M+Color					Note 10: Harmonic Imaging
	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD					Note 11: Contrast Imaging
	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD				Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES				Note 14: TDI
	Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development				Note 15: Elastography
	Note 8: Panoramic Imaging
Note 16: ElastPQ (for Liver)				Note 17: PercuNav
	Previous Submission: K163120 EPIQ/Affiniti
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler**	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,,12,13

23

System:
Transducer:
Intended Use:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

VL13-5
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

w indication; P= previously clea

Additional Comments :

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	Note 16: ElastPQ (for Liver)	Note 17: PercuNav
*Color Doppler includes Color Amplitude Doppler	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 2: Combined modes include: B+M+Color	Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 5: SonoCT	Note 6: Imaging for guidance of biopsy	Note 7: Infertility monitoring of follicle development	Note 8: Panoramic Imaging	Previous Submission: K163120 EPIQ/Affiniti

24

agnostic ultrasound indications for use statemen

EPIQ 7 Diagnostic Ultrasound Systems
X5-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 510(k) No:
System:
Transducer:
Transducer:
Intended Use:

ended 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)	Ophthalmic	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB		P	P	P		P	Note: 1,2,3	Note: 8,9,10,,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	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; Note 10: Harmonic Imaging
B+M

*Color Doppler includes Color Amplitude Doppler (CPA)	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: PercuNav
Previous Submission: K163120 EPIQ/Affiniti

25

EPIQ 7 Diagnostic Ultrasound Systems 510(k) No:
System:
Transducter:
Intended Use:

X6-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)
Ophthalmic	Ophthalmic	P
Fetal Imaging
& Other	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)
	Laparoscopic
	Pediatric	P	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	P	Note: 1,2,3	Note: 6,8,9,10, 12,13
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
	Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note: 1,2,3
		Cerebral Vascular	P	P	P	P	P	Note: 1,2,3
	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	P	P	P
	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	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,
Peripheral
Vessel	Peripheral vessel						Note: 1,2,3
	Cerebral Vascular

Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: K.I 63 I20 EPIQ/Affiniti

Note 5: SonoCT

26

510(k) No:

EPIQ 7 Diagnostic Ultrasound Systems

ultrasound imaging or fluid flow analysis of the human body X7-2
Diagnostic System:
Transducer:
Intended Use:

indication; ﺎﻥ =

Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 9: EFOV including Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K163120 EPIQ/Affiniti

27

agnostic ultrasound indications for use statemen

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

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems
X7-2t
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 Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P		Note: 1,2,3,4
Note: 10,,12,13,14
	Cardiac Pediatric	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:

Additional Comments:

Department of Public Works

*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;	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: PercuNav
Previous Submission: K163120 EPIQ/Affiniti

28

EPIQ 7 Diagnostic Ultrasound Systems 510(k) No:
System:
Transducer:
Intended Use:

X8-2t
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

| General
(Track I only) | Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---|---|-----|-----|---------------------------------------------------|----------------------|--------------------|---------------------------------------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
& Other | Fetal / OB | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid, testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | | | | | | | | |
| | Other: Urology | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| | Cardiac Pediatric | 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 | | | | | | | | |
| | | | | | | | | | |
| General
(Track I only) | Clinical Application
Specific
(Tracks I & III) | | | | | Mode of Operation (includes simultaneous B-mode) | | | |
| Ophthalmic | Ophthalmic | B | M | PWD | CWD | Color
Doppler | Combined* | Other
(Spec.) | Other
(Spec.) |
| | 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: 10,11,12,13,14
Note: 1,2,3,4 |
| | Cardiac Pediatric | | | P | P | P | P | P | Note 10, 13,14
Note: 1,2,3,4 |
| | Trans-esophageal (Cardiac) | | | P | P | P | P | P | Note: 10,12,13,14
Note: 1,2,3,4 |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral Vascular | | | | | | | | |
| N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M
Note 9: Color Power Angio (CPA)
Note 10: Harmonic Imaging | | | | | | | | | |

Note 14: TDI
Note 15: Elastography
Note 16: ElastPQ (for Liver)
Note 17: PercuNav

Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development
Note 8: Panoramic Imaging
Previous Submission: K163120 EPIQ/Affiniti

Note 5: SonoCT

29

System:

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

B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography
Note 8: Panoramic Imaging	Note 16: ElastPQ (for Liver)
Previous Submission: K163120 EPIO/Affiniti	Note 17: PercuNav

Previous Submission: K163120 PERIO Affidaviti

30

x8-2ti

transducer:

System:

	Clinical Application					Mode of Operation (*includes simultaneous B-mode)
		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	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	N	N	N	N	N		Note: 10,12,13,14
Cardiac	Cardiac Pediatric	N	N	N	N	N		Note: 10,12,13,14
	Trans-esophageal (Cardiac)
Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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: K163120 EPIQ/Affiniti

31

System:

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
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	N	N	N		N		Note: 1,2,3
Vessel	Cerebral Vascular	N	N	N		N		Note: 1,2,3
	N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 9: Color Power Angio (CPA)
								Note:
5,6,8,9,10,11,12,13,17
Note: 5,6,8,9,10,11,12,13

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CPA)
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;
B+M	Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color	Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD;
B+Amplitude+PWD	Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastography
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging	Note 17: PercuNav
Previous Submission: K163120 EPIQ/Affiniti

32

agnostic ultrasound indications for use statemen

| System:
Intended Use: | Affiniti 70/50/30 Diagnostic Ultrasound Systems
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 | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,17 | |
| | Abdominal | P | 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 | P | Note: 1,3 | Note: 5,8,10,12,13 | |
| | Intra-operative (Vascular) | P | P | P | P | P | Note: 1,3 | Note: 5,8,10,12,13 | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | 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 | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,15,17 | |
| | Neonatal Cephalic | P | P | P | P | P | Note: 1,3 | Note: 5,8,9,10,12,13 | |
| | Adult Cephalic | P | P | P | P | P | Note: 1,3 | Note: 8,10,12,13 | |
| | Trans-rectal | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| | Trans-vaginal | P | P | P | P | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13,15,17 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| | Musculo-skel. (Conventional) | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| | Musculo-skel. (Superficial) | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| | Intra-luminal | | | | | | | | |
| | Other: GYN | P | P | P | P | P | | Note: 5,6,7,8,9,10,11,12,13,
15,17 | |
| | Other: Urology | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,11,12,13,
15,17 | |
| | Cardiac Adult | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,11,12,13,14 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note: 1,2,3,4 | Note: 10,12,13,14 | |
| | 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 | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| E = added via Appendix E, N= new indication, P= previously cleared
Additional Comments: | | | | | | | | | |

Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography
Note 8: Panoramic Imaging	Note 16: ElastPQ (for Liver)
Previous Submission: K163120 EPIQ/Affiniti	Note:17 PercuNav

33

Affiniti 70 Diagnostic ULTRASOUND INDICATIONS FOR USE STATEMENT

CS-1
CS-1
DiaEnostic ultrasound Systems
DiaEnostic ultrasound imaging or fluid flow analysis of the human bod

System:
Transducer:
Intended Use

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,
8,9,10,11,12,13,15,16,17
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	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	P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13,17
	Other: Urology	P	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	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: K163120 FPIO/Affiniti

34

System:
Transducer:
Intended Use

.....

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	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13,15
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	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	P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13
	Other: Urology	P	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	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
Previous Submission: K163120 EPIQ/Affiniti

35

്കുന്നു. അവലംബം പ്രസ്കാരിയോടിന് ആയാം

Affiniti 70/50/30 Diagnostic Ultrasound Systems
C8-5
Diagnostic ultrasound imaging or fluid flow analysis

System:
Transducer:
Intended Use

follo t nalvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal / OB	Abdominal	P	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	P	Note: 1,3	Note: 5,6,8,9,12,13
		Small Organ (breast, thyroid, testicle)
		Neonatal Cephalic	P	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	P	Note: 1,3	Note: 5,6,8,9,12,13
		Cerebral Vascular	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,12,13

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
Previous Submission: K163120 EPIQ/Affiniti

36

Affiniti 70 Diagnostic Ultrasound Systems

C9-2
Diagnostic ultrasound imaging or fluid flow

System:
Transducer:
Intended Use

follo નું ત cis

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
E = added via Appendix E

E-added via Appendix

= = added diaded the 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: K163120 EPIQ/Affiniti

37

	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
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
Fetal Imaging
& Other		Laparoscopic
		Pediatric
		Small Organ (breast, thyroid, testicle)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal	P	P		P	P	Note: 1,3	Note: 5,6,7, 8,10,12,13, 15
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Conventional)
		Musculo-skel. (Superficial)
		Intra-luminal
		Other: GYN	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
Vessel		Peripheral vessel
		Cerebral Vascular
	P = added via Appendix E, N= new indication. P= previously cleared

Affiniti 70 Diagnostic Ultrasound Systems
C10-3v
Di System:
Transducer:

E = added via Appendix E, N= new indication. P= previo

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: K163120 EPIQ/Affiniti

38

diagnostic ultrasound indications for use statement

System:
Transducer:
Intended Use:

Affiniti 70/50/30 Diagnostic Ultrasound Systems
3D9-3v
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

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
Previous Submission: K163120 EPIQ/Affiniti

39

| 144
SUATA
1
900
œ
PP My
t be the state of the state of the states of the states of the states of the states of the states of the station of the states of the states of the station of the station of
1
0
œ
I
8
œ
œ
I

4

1
44

System:
Transducer:
Intended Use

follo alvsis fluid C9-4v
Diagnosti

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | | | | | | Mode of Operation (includes simultaneous B-mode) | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|---------------------------------------------------|--------------------------------|
| | | | | | | | Combined
(Spec.) | Other
(Spec.) |
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | P | P | P | | P | Note: 1,3 | Note: 5,6,7,8,9,10,12,13 |
| | Abdominal | | | | | | | |
| | Intra-operative (Cardiac) | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast, thyroid, testicle) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | Note: 1,3 | Note: 5,6,7, 8,10,12,13, 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
Vessel | Peripheral vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |
| | E= added via Appendix E | | | | | | | |

E=added via Appendix.

E = added via Appendi
N= new indication

P= previously cleared

previously circulated

| AMA
wa wa | A 100 10 1141 10 0
0 00 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 11/11/11/11/11/11/11/11/11/11/11/11/11/11/11/2017/11/2017/11/2017/11/2017/11/2017/11/2017/11/2019/11/2019/11/2019/11/2019/11/2019/11/2017/11/2017/11/2017/11/2017/11/2017/11/2 | 000 00 000 00000 |
| | 5 |

*Color Doppler includes Color Amplitude Doppler	Note 9: Color Power Angio (CP
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude;	Note 10: Harmonic Imagin
Note 2: Combined modes include: B+M+Cold	lote 11: Contrast Imagi
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+P\	Note 12: 3D/4D Imagin
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CW	Note 13: XRES
Note 5: SonoCT	Note 14: TDI
Note 6: Imaging for guidance of biopsy	Note 15: Elastograph
Note 7: Infertility monitoring of follicle development	Note 16: ElastPQ (for Liver
Note 8: Panoramic Imaging
Previous Submission: K163120 EPIQ/Affini

40

System:
Transducer:
Intended Use

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

| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|-------------------|----------------------|--------------------------------|
| General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
| Ophthalmic | Ophthalmic | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 |
| | Fetal / OB | P | 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 | P | Note: 1,3 | Note: 5,6,7, 8,9,10,12,13,17 |
| | Trans-vaginal | P | 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 | P | Note: 1,3 | Note: 5,6,7,8,9,10,11,12,13,17 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (Fetal Echo) | P | P | P | P | P | Note: 1,3 | Note: 5,6,8,10,12,13 |
| Peripheral
Vessel | Peripheral Vessel | | | | | | | |
| | Cerebral Vascular | | | | | | | |

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: K163120 EPIQ/Affiniti

41

| | Transducer: BP10-5EC
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 | P | | P | | P | | Note: 1,3 | |
| | 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 | | | | | P | | Note: 5,6,8,9,10,12,13 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral Vascular | | | | | | | | |
| | F= added via Appendix E, N= new indication, P= previously cleared | | | | | | | | |

Affiniti 70/50 Diagnostic Ultrasound Systems

BP10-5ec System:
Transducer

ended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follo

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

Additional Comments

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: K163120 EPIQ/Affiniti

42

Transducer:	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:		Mode of Operation (*includes simultaneous B-mode)
Clinical Application		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	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
	Cerebral Vascular
								P

Affiniti 70/50/30 Diagnostic Ultrasound Systems
D2cwc System:
Transducer:

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

ANTC
AMM
(
(
ITIANI
ANIV
0

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: K163120 EPIO/Affiniti

43

Affiniti 70/50 Diagnostic Ultrasound Systems

D2tcd

System:
Transducer:
Internationals durin

= body : alysis of the human fluid flo ii d in

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			P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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
Previous Submission: K163120 EPIO/Affiniti

44

Affiniti 70/50 Diagnostic Ultrasound Systems

D5cwc
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

follo to lvsis

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

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

ments Additional

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: K163120 EPIQ/Affiniti

45

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track I only)	Clinical Application
Specific
(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)				Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
		B	M	PWD	CWD
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,3	Note: 5,6, 8,9,10,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Small Organ (breast, thyroid, testicle)	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Neonatal Cephalic	P	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	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	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	P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P	P	P	Note: 1,3	Note: 5,6,8,9,10,12,13
ded via Appendix E, N= new indication, P= previously cleare

Affiniti 70 Diagnostic Ultrasound Systems
L12-3 System:
Transducer:

b ﺭ ﺍﻟ 1ob

nal Co Additio

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: K163120 EPIQ/Affiniti

46

System:	Affiniti 70/50/30 Diagnostic Ultrasound Systems
Transducer:	L12-4
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body

| Transducer: L12-4

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track I only)	Clinical Application
Specific
(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)						Other
(Spec.)
		B	M	PWD	CWD	Color
Doppler*	Combined*
(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
& Other	Laparoscopic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

P

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: K163120 EPIQ/Affiniti

47

| System:
Transducer:
Intended Use: | Affiniti 70/50/30 Diagnostic Ultrasound Systems
L12-5 50
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
& Other | 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 | | | | | | | | |
| | 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 | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (Fetal Echo) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |
| | Cerebral Vascular | P | P | P | | P | Note: 1,3 | Note: 5,6,8,9,10,12,13,17 | |

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

| 0

Address the land to the been the been the beginner of the beginner of the bestille the bestille the bestille the bestille the bestille the bestille the bestille the bestille	:
10-0
100
0
9	1
1
1
C	o

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: K163120 EPIQ/Affiniti

48

| MA A
2
svstei
119
Inschi
ﻟﺘﺎﺭﻳﺨﺎ ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
.
Diagnosti
1
EU

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: 4. :
ais

1
tem

L15-7io
Diagnostic System:
Transducer:
Intended Use:

follo ರಕ -ho to nalvsis or fluid flo ui 7

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

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
Previous Submission: K163120 EPIQ/Affiniti

49

diagnostic ultrasound indications for use statement

510(k) No: ___________________________________________________________________________________________________________________________________________________________________

Transducer:

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

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

Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 16: ElastPQ (for Liver) Note 12: 3D/4D Imaging Note 15: Elastography Note 17: PercuNav Note 13: XRES Note 14: TDI Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 4: Combined modes include: B+CWD; B+Color+CWD; Note 7: Infertility monitoring of follicle development Note 2: Combined modes include: B+M+Color Note 8: Panoramic Imaging
Previous Submission: K163120, EPIQAffiniti Note 6: Imaging for guidance of biopsy B+Amplitude+CWD Note 5: SonoCT

50

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track I only)	Specific
(Tracks I & III)	Mode of Operation (*includes simultaneous B-mode)					Combined*
(Spec.)	Other
(Spec.)
		B	M	PWD	CWD	Color
Doppler*
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
& Other	Laparoscopic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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
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
	F= added via Appendix F. N= new indication. P= previously cleared

Affiniti 70/50 Diagnostic Ultrasound Systems
L18-5 System:
Transducer:

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

dditio

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: K163120 EPIQ/Affiniti

51

| System:
Transducer:
Intended Use: | Affiniti 70 Diagnostic Ultrasound Systems
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|------------|-----|-----|-------------------|---------------------------------------------------------------------------|----------------------------|
| General
(Track I only) | Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Mode of Operation (includes simultaneous B-mode)
Combined
(Spec.) | Other
(Spec.) |
| | | | Ophthalmic | Ophthalmic | | | | | |
| | Fetal / OB | | 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, 8,9,10,12,13,17 |
| | Intra-operative (Cardiac) | | | | | | | | |
| | Intra-operative (Vascular) | | | | | | | | |
| Fetal Imaging
& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (breast, thyroid, testicle) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | P | P | P | | P | Note: 1,3 | Note: 8,9,10,12,13,17 |
| | 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
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) | | | | | | | | | |

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: K163120 EPIQ/Affiniti

52

System:
Transducer:
Intended Use

follo to alvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P	P	P	Note: 1,3	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	P	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	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
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
Previous Submission: K163120 EPIQ/Affiniti

53

Affiniti 70/50 Diagnostic Ultrasound Systems

S7-3t
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

ട് nalvsis

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Specific
(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	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
	added via Appendix E, N= new indication, P= previously cleared

E = added via Appendix E, N= new indication, P= previou

Additional Comments

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: K163120 EPIQ/Affiniti

54

| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation (includes simultaneous B-mode) | | | | | | | | | |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|----------------------|
| Transducer | Clinical Application | General
(Track I only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined*
(Spec.) | Other
(Spec.) |
| | Ophthalmic | | Ophthalmic | | | | | | | |
| | Fetal / OB | | | P | P | P | P | P | Note: 1,3 | Note: 7,8,9,10,12,13 |
| | Abdominal | | | P | 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 | P | Note: 1,3 | Note: 8,10,12,13 |
| | Small Organ (breast, thyroid, testicle) | | | | | | | | | |
| | Neonatal Cephalic | | | P | P | P | P | P | Note: 1,3 | 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) | | | P | P | P | P | P | Note: 1,3 | Note: 10,12,13 |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Cerebral Vascular | | | | | | | | | |
| F = added via Appendix F. N= new indication P= previously cleared | | | | | | | | | | |

Affiniti 70/50/30 Diagnostic Ultrasound Systems

S8-3 System:
Transducer:

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

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

Addition:

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: K163120 EPIQ/Affiniti

55

diagnostic ultrasound indications for use statement

Analysis of the human fluid film rupture of a micro-textured surface

Clinical Application						Mode of Operation (*includes simultaneous B-mode)
	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
Fetal Imaging
& 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	Cardiac Adult	P	P	P		P	Note: 1,2,3,4	Note: 10,,12,13,14
	Cardiac Pediatric	P	P	P		P	Note: 1,2,3,4	Note: 10,,12,13,14
	Trans-esophageal (Cardiac)	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:

| Additional Comments:

*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 9: Color Power Angio (CPA)
Note 2: Combined modes include: B+M+Color	Note 10: Harmonic Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 11: Contrast Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD;
B+Amplitude+CWD	Note 12: 3D/4D Imaging
Note 5: SonoCT	Note 13: XRES
Note 6: Imaging for guidance of biopsy	Note 14: TDI
Note 7: Infertility monitoring of follicle development	Note 15: Elastography
Note 8: Panoramic Imaging	Note 16: ElastPQ (for Liver)
Previous Submission: K163120, EPIQ	Note 17: Percu Nav

56

diagnostic ultrasound indications for use statement

Affiniti 70/50 Diagnostic Ultrasound Systems

S12-4
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
Clinical Application	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	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

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

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: K163120 EPIQ/Affiniti

57

Affiniti 70/50/30 Diagnostic Ultrasound Systems

V6-2
Diagnostic ultrasound imaging or fluid flow analysis of the l

System:
Transducer:
Intended Use:

human body as follow

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

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

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: K163120 EPIQ/Affiniti

58

Affiniti 70/50 Diagnostic Ultrasound Systems

X7-2t
Diagnostic ultrasound imaging or fluid flow ana

System:
Transducer:
Intended Use

asound imaging or fluid flow analysis of the human body as follow

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:	Mode of Operation (*includes simultaneous B-mode)
	Clinical Application	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Ophthalmic
Ophthalmic	Ophthalmic
	Fetal / OB
	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	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
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
Previous Submission: K163120 EPIQ/Affiniti

59

System:
Transducer:

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

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)
Clinical Application	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
Peripheral
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	= added via Appendix E. N= new indication, P= previously cleared

d pp

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

60

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 8807.92

• 1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431
     Maxs Newberry, Regulatory Affairs Engineer Contact person: Email: Maxs.newberry(@philips.com Tel: [phone] Fax: [phone]

Date prepared: October 3, 2017

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:

Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affmiti 30 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:

61

Product		510(k)
Philips EPIQ Diagnostic Ultrasound
System and Philips Affiniti Diagnostic
Ultrasound System	Primary Predicate
Device	K163120
Philips EchoNavigator	Predicate Device	K121781

4. Device Description

The proposed EPIO 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, multipin connectors.

5. Indications for Use

The intended use of the EPIQ series, Affiniti 30 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:

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.

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

The clinical environments where the EPIO and Affiniti 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 (K163120), employ the same fundamental scientific technology. The primary differences are the addition of the eL18-4 transducer to the EPIQ and Affiniti Diagnostic Ultrasound Systems, the addition of the XL14-3 and X8-2ti

62

transducers to the EPIQ Diagnostic Ultrasound System, and the addition of a new EchoNavigator mode that allows compatibility with the Philips EchoNavigator software tool.

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 Philips EchoNavigator 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 Philips EchoNavigator.
Standard
Feature	Philips
EchoNavigator
(K121781)
(Predicate device)	EPIQ
K163120 (Primary
Predicate Device)	EPIQ 1.8
(Proposed Device)	Affiniti
K163120
(Primary
Predicate
Device)	Affiniti 1.8
(Proposed
Device)
Indications
for Use	EchoNavigator
supports the
interventionalist and
surgeon in treatments
where both live X-ray
and live Echo
guidance are used.
The targeted patient
population consists of
patients with
cardiovascular
diseases requiring
such a treatment.	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	Same as EPIQ
K163120 but with
the addition of
integration with
Philips
EchoNavigator
(K121781) software
tool	Same as EPIQ
K163120	Same as
EPIQ
K163120

| | cardiovascular
diseases requiring
such a treatment. | Transrectal, Transvaginal
Musculoskeletal
(Conventional),
Musculoskeletal
(Superficial)
Gynecological, Other:
Urology, Cardiac Adult,
Cardiac Pediatric,
Transesophageal
(Cardiac),
Cardiac other (Fetal),
Peripheral Vessel,
Cerebral Vascular, | | | |
|-------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Transducers | N/A | 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,
S8-3t, S12-4, V6-2, X7-2t,
X8-2t D2tcd, X5-1, X6-1,
VL13-5, X7-2, 3D9-3v | Same as EPIQ
K163120 with
addition of eL18-4,
XL14-3 and X8-2ti
transducers | 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
K163120
with addition
of the eL18-
4 transducer |

63

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 Philips EchoNavigator.

| Standard
Feature | Philips
EchoNavigator
(K121781)
(Predicate device) | EPIQ
K163120 (Primary
Predicate Device) | EPIQ 1.8
(Proposed Device) | Affiniti
K163120
(Primary
Predicate
Device) | Affiniti 1.8
(Proposed
Device) |
|-----------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Transducer
Types | N/A | Phased array Linear array Curved array Pencil Probes Multi-plane
Transesophageal Motorized arrays 3D Matrix Array | Same as EPIQ
K163120 | Phased array Linear array Curved
array Pencil
Probes Multi-plane
Transesopha
geal Motorized
arrays | Same as
Affiniti
K163120 |
| Transducer
Frequency | N/A | 1.0 - 18.0 MHz | Same | Same | Same |
| Acoustic
Output
Display &
FDA Limits | N/A | IEC 62359
ISPTA max=720
mw/cm2MI max =1.9MI displayTI display | Same | Same | Same |
| Imaging
Mode | N/A | B mode, M mode, PWD,
CWD, Color Doppler,
Combined modes, | Same | Same | Same |
| Shear wave | N/A | ElastPQ | Same | Same | Same |
| Elastography | N/A | ElastQ Imaging | Same | NA | NA |
| # Transmit
Channels | N/A | 128 | Same | Same | Same |
| # Receive
Channels | N/A | 256 | Same | Same | Same |
| 510(k) Track | N/A | Track 3 | Same | Same | Same |
| Product
Safety
Certification | N/A | CSA International
IEC 60601-1
C22.2 No. 60601-1
ANSI/AAMI ES60601-1
IEC 60601-2-37 | Same | Same | Same |
| EMC
Compliance | N/A | IEC 60601-1-2 | Same | Same | Same |
| Patient
Contact
Materials | N/A | | No changes from EPIQ K163120 | | |
| Standard
Feature | Philips
EchoNavigator
(K121781)
(Predicate device) | EPIQ
K163120 (Primary
Predicate Device) | EPIQ 1.8
(Proposed Device) | Affiniti
K163120
(Pramary
Predicate
Device) | Affiniti 1.8
(Proposed
Device) |
| Accessories | | Various hardcopy, recording and printing devices: video thermal printer, report printer, DVD, USB PercuNav Instruments Biopsy guides Footswitch | Addition of video switch for compatibility with EchoNavigator | Same | Same |

64

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 Philips EchoNavigator.

7. Safety Considerations

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

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

The system acoustic output limits are:

• . Ispta.3 ≤ 720 MW/cm2
• MI