Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a general-purpose diagnostic ultrasound system and mentions standard image and signal processing, but there is no mention of AI, ML, deep learning, or any related terms or concepts in the provided text.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states that the device's purpose is "diagnostic ultrasound imaging and fluid flow analysis of the human body." It also mentions assisting with "image guidance during treatment," but the primary function is diagnostic, not therapeutic.

Diagnostic

Yes

The product's "Intended Use / Indications for Use" section explicitly states "The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body..." and later mentions "clinical point-of-care for diagnosis of patients." Additionally, the "Device Description" refers to them as "general purpose, software controlled, 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:

Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device's function is to "acquire ultrasound data and to display the data in various modes of operation." This is a non-invasive imaging technique that uses sound waves to create images of internal body structures.
Intended Use: The intended use describes diagnostic ultrasound imaging and fluid flow analysis of the human body. This involves directly imaging the patient, not analyzing samples taken from the patient.
Clinical Environment: The clinical environments listed (Clinics, Hospitals, clinical point-of-care) are consistent with where ultrasound imaging is performed directly on patients.

The device is a diagnostic ultrasound system, which is a medical device used for imaging, but it does not perform in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

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

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

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

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

IYN, IYO, ITX

Device Description

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

The removable transducers are connected to the system using a standard technology, multi-pin connectors. Other than the introductions of the two new transducers, the device description, accessories and components are unchanged, reference table 1.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Adult, Neonatal, Pediatric, Fetal

Intended User / Care Setting

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

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

Not Found

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

Not Found

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

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures can be located in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.

All testing was used to support substantial equivalence of the subject device and demonstrate that the proposed Philips EPIQ Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems:

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

The proposed Philips EPIQ Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems did not require clinical studies since substantial equivalence to the currently marketed predicate devices has been established.

For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the proposed Philips EPIO Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems with the new V9-2 and mC7-2 transducers met their intended use.

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.

K181485

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.

K150122

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2018

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

Re: K182857

Trade/Device Name: EPIQ Diagnostic Ultrasound System, 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: Class II Product Code: IYN, IYO, ITX Dated: October 30, 2018 Received: November 2, 2018

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely.

Hole 2. Nils

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K182857

Device Name

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

Indications for Use (Describe)

The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal.

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

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

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

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

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3

510(k) No: _K182857

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

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

Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific			PWD	CWD	Color	Combined	Other
(Track I only)	(Tracks I & III)	B	M			Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,
13,15,16,17,18, 19
	Intra-operative (Cardiac)	P	P	P	P	P	Note: 1,2,3	Note: 5,8,9,10, 12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10, 12,13
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,17,18
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note:5,6,8,9,10,11,12,13,15,17,
19
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13,17
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10, 12,13,17
	Trans-rectal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
11,12,13,15,17
	Trans-vaginal	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,
11,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, ,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, ,12,13,17
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,15,17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,15,17
Cardiac	Cardiac Adult	P	P	P	P	P	Note:
1,2,3,4	Note: 10,11,12,13,14
	Cardiac Pediatric	P	P	P	P	P	Note:
1,2,3,4	Note: 10, ,12,13,14
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note:
1,2,3,4	Note: 10, ,12,13,14
	Other (Fetal Echo)	P	P	P	P	P	Note:
1,2,3,4	Note: 5,6,8,10,12,13,14
Peripheral	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,17
Vessel	Cerebral vascular	P	P	P	P	P	Note: 1,2,3	Note: 5,6,8,9,10, 11,12,13,17

N= new indication P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous submission: K181485

4

510(k) No: K182857

System: Transducer: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

3D9-3v

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

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

Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

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

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

5

510(k) No: _K182857

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

Transducer: C5-1

Note 6: Imaging for guidance of biopsy

Note 8: Panoramic Imaging

Note 9: Color Power Angio (CPA)

Previous submission: K181485

Note 7: Infertility monitoring of follicle development

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

Clinical Application				Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,12,13
	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	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
,12,13,17,18
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,2,3	Note: 5,6,7,8, 9,10,11
,12,13, 17
	Other: Urology	P	P	P		P	Note: 1,2,3	Note: 5,6,8, 9,10,
,12,13, 17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,2,3	Note: 5,6,10,12,13
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
11,12,13,17
Vessel	Cerebral vascular
	N= new indication
P= previously cleared
	Additional Comments:
*Color Doppler includes Color Amplitude Doppler				Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M				Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color					Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD					Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD					Note 14: TDI
Note 5: SonoCT						Note 15: Elastography

Note 16: ElastPQ (for Liver)

Note 19: ElastQ Imaging Linear

Note 18: ElastQ Imaging

Note 17: Percu Nav

6

510(k) No: K182857

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

Transducer: C8-E

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

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

Note 15: Elastography

Note 17: Percu Nav

Note 16: ElastPQ (for Liver)

Note 18: ElastQ Imaging Note 19: ElastQ Imaging Linear

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+
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: K181485

7

510(k) No: K182857

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

Transducer: C9-2

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

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

N= new indication P= previously cleared

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous submission: K181485

8

510(k) No: K182857

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: C10-3v

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

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

N= new indication P= previously cleared

Additional Comments: *Color Doppler includes Color Amplitude Doppler Note 10: Harmonic Imaging Note 11: Contrast Imaging Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M Note 2: Combined modes include: B+M+Color Note 12: 3D/4D Imaging Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD Note 13: XRES Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD Note 14: TDI Note 5: SonoCT Note 15: Elastography Note 6: Imaging for guidance of biopsy Note 16: ElastPQ (for Liver) Note 7: Infertility monitoring of follicle development Note 17: Percu Nav Note 8: Panoramic Imaging Note 18: ElastQ Imaging Note 19: ElastQ Imaging Linear Note 9: Color Power Angio (CPA) Previous Submission: K181485

9

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
	Fetal / OB		P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal		P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,9,10,
1112,13,17
	Trans-vaginal		P	P	P		P	Note: 1,2,3	Note: 5,6,7, 8,9,10,
12,13,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN		P	P	P		P	Note: 1,2,3	Note: 5,6,7,8,9,10,
12,13,17
	Other: Urology		P	P	P		P	Note: 1,2,3	Note:
5,6,7,8,9,10,11,12,13,17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)		P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
Peripheral	Peripheral vessel		P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10, 12,13,
17
Vessel	Cerebral Vascular
	N= new indication
P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler								Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M									Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color									Note 12: 3D/4D Imaging
	Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD							Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD									Note 14: TDI

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

10

510(k) No: K182857

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

Transducer: D2cwc

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel.
(Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult				P
Cardiac	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 10: Harmonic Imaging
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M					Note 11: Contrast Imaging
	Note 2: Combined modes include: B+M+Color					Note 12: 3D/4D Imaging
	Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD					Note 13: XRES
	Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD					Note 14: TDI
Note 5: SonoCT						Note 15: Elastography
Note 6: Imaging for guidance of biopsy						Note 16: ElastPQ (for Liver)
	Note 7: Infertility monitoring of follicle development					Note 17: PercuNav
Note 8: Panoramic Imaging						Note 18: ElastQ Imaging

11

510(k) No: _K182857

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

Transducer: D2tcd

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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

Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic			P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular			P
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler						Note 10: Harmonic Imaging
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
	Note 2: Combined modes include: B+M+Color						Note 12: 3D/4D Imaging
	Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
	Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT							Note 15: Elastography
Note 6: Imaging for guidance of biopsy							Note 16: ElastPQ (for Liver)
	Note 7: Infertility monitoring of follicle development						Note 17: PercuNav
Note 8: Panoramic Imaging							Note 18: ElastQ Imaging

12

510(k) No: K182857

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

Transducer: D5cwc

Note 9: Color Power Angio (CPA) Previous Submission: K181485

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel				P
	Cerebral Vascular				P
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M			Note 10: Harmonic Imaging
Note 2: Combined modes include: B+M+Color			Note 11: Contrast Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD			Note 12: 3D/4D Imaging
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD			Note 13: XRES
Note 5: SonoCT			Note 14: TDI
Note 6: Imaging for guidance of biopsy			Note 15: Elastography
Note 7: Infertility monitoring of follicle development			Note 16: ElastPQ (for Liver)
Note 8: Panoramic Imaging			Note 17: PercuNav
Note 9: ElastQ Imaging			Note 18: FlastQ Imaging

13

510(k) No: _K182857

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

Transducer: L12-3

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

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

P= previously cleared N= new indication

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

14

510(k) No: _K182857

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

Transducer: L12-5 50

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10, 12,13, 17
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,15,17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,
12,13,17
Vessel	Cerebral Vascular	P	P	P		P	Note: 1.2.3	Note: 5.6.8.9.10. 12.13

N= new indication P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

15

510(k) No: _K182857

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

Transducer: L15-7io

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,2,3	Note: 5,8,10,,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,8,9,10,,12,13
N= new indication P= previously cleared
Additional Comments:
*Color Doppler includes Color Amplitude Doppler
Note 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 16: ElastPQ (for Liver)

Note 17: Percu Nav

Note 18: ElastQ Imaging

Note 19: ElastQ Imaging Linear

Note 9: Color Power Angio (CPA) Previous Submission: K181485

Note 8: Panoramic Imaging

Note 7: Infertility monitoring of follicle development

16

510(k) No: _K182857

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

Transducer: eL18-4

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
15,17,19
	Intra-operative (Vascular)
	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,10,12,13, 17
	Neonatal Cephalic	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13,
15,17,19
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,12,13,17
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
N= new indication P= previously cleared

N= new indication
Additional Commer

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

17

E10(λ) No: K182857

510(k) No: _K182857

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

Transducer: L18-5

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

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

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

18

510(k) No: _K182857

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

Transducer: S5-1

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10,12,13, 17
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10, ,12,13, 17
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14, 17
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10, 12,13,14, 17
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,13,14
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note: 6,8,9,10, 12,13, 17
	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color						Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT							Note 15: Elastography
Note 6: Imaging for guidance of biopsy						Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development						Note 17: PercuNav
Note 8: Panoramic Imaging							Note 18: ElastQ Imaging

19

510(k) No: K182857

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

Transducer: S7-3t

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

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

Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

20

510(k) No: K182857

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

Transducer: 58-3

Note 8: Panoramic Imaging

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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

Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& 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 Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color						Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT					Note 15: Elastography
Note 6: Imaging for guidance of biopsy					Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development							Note 17: PercuNav

Note 18: ElastQ Imaging

21

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

Transducer: S8-3t

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

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

Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

22

510(k) No: _K182857

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

Transducer: S12-4

Note 8: Panoramic Imaging

Note 9: Color Power Angio (CPA)

Previous Submission: K181485

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	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	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
	P= previously cleared
N= new indication
Additional Comments:
*Color Doppler includes Color Amplitude Doppler						Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color						Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT						Note 15: Elastography
Note 6: Imaging for guidance of biopsy						Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development							Note 17: PercuNav

Note 18: ElastQ Imaging

23

K182857 510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: V6-2

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / 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 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
Note 18: ElastQ Imaging
Note 19: ElastQ Imaging Linear
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: K181485

24

510(k) No: K182857

System: EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

Transducer: VL13-5

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

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

N= new indication; P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

25

K182857 510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: XL14-3

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
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1, 2, 3	Note: 5, 6, 8, 9, 10, 11,
12, 13, 17
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,2,3	Note: 5,6,8,9,10,11,12,13
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
	Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
		Note 2: Combined modes include: B+M+Color						Note 12: 3D/4D Imaging
		Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
		Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
		Note 5: SonoCT						Note 15: Elastography
		Note 6: Imaging for guidance of biopsy					Note 16: ElastPQ (for Liver)
		Note 7: Infertility monitoring of follicle development						Note 17: PercuNav
		Note 8: Panoramic Imaging						Note 18: ElastQ Imaging
		Note 9: Color Power Angio (CPA)						Note 19: ElastQ Imaging Linear
		Previous Submission: K181485

26

K182857 510(k) No:

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

Transducer:

X5-1

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,2,3	Note: 8,9,10,,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,2,3	Note: 8,9,10, 12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	Note: 1,2,3	Note: 8,9,10, 12,13
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10, 12,13,14
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M							Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color							Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT						Note 15: Elastography
Note 6: Imaging for guidance of biopsy							Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development						Note 17: PercuNav
Note 8: Panoramic Imaging					Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)							Note 19: ElastQ Imaging Linear

Previous Submission: K181485

27

K182857 510(k) No:

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

Transducer: X6-1

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10,12,13
	Abdominal	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10,11,12,13,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P	P	P	Note: 1,2,3	Note:
6,8,9,10,11,12,13,17
Vessel	Cerebral Vascular	P	P	P	P	P	Note: 1,2,3	Note: 6,8,9,10,12,13,17

N= new indication Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

28

X7-2

510(k) No: K182857

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

Intended Use:

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

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

N= new indication; P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

29

510(k) No:

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

K182857

Transducer: X7-2t

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

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

N= new indication P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

30

K182857 510(k) No:

EPIQ and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: X8-2t

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

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

N= new indication P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

31

K182857 510(k) No:

EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: X8-2ti

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M
Note 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
			Note 18: ElastQ Imaging
			Note 19: ElastQ Imaging Linear

Previous Submission: K181485

32

K182857 510(k) No:

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

Transducer: ട9-2

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,2,3	Note: 7,8,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& 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 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: 1,2,3,4	Note: 10,12,13,14
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular
	N= new indication
P= previously cleared
	Additional Comments:
*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color							Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 13: XRES
Note 5: SonoCT						Note 14: TDI
Note 15: Elastography
Note 6: Imaging for guidance of biopsy					Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development							Note 17: PercuNav
Note 8: Panoramic Imaging					Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)						Note 19: ElastQ Imaging Linear

Previous Submission: K181485

33

K182857 510(k) No:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems System:

Transducer: V9-2

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	N	N	N		N	Note: 1,2,3	Note: 5,6,8,9,10,12,13
	Abdominal	N	N	N		N	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)	N	N	N		N	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 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M						Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color					Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD						Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD						Note 14: TDI
Note 5: SonoCT					Note 15: Elastography
Note 6: Imaging for guidance of biopsy					Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development					Note 17: PercuNav
Note 8: Panoramic Imaging					Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)							Note 19: ElastQ Imaging Linear

34

(k) No:	K182857

510(k) N
System:

EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems

Transducer: mC7-2

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB						Note: 1,2,3	Note:
5,6,8,9,10,11,12,13,17
	Abdominal	N	N	N	N	N	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	N	N	N	N	N	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)
	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
	N= new indication
P= previously cleared
	Additional Comments:
	*Color Doppler includes Color Amplitude Doppler					Note 10: Harmonic Imaging
		Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M					Note 11: Contrast Imaging
		Note 2: Combined modes include: B+M+Color					Note 12: 3D/4D Imaging
		Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD					Note 13: XRES
		Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD					Note 14: TDI
		Note 5: SonoCT					Note 15: Elastography
		Note 6: Imaging for guidance of biopsy
Note 7: Infertility monitoring of follicle development					Note 16: ElastPQ (for Liver)
		Note 8: Panoramic Imaging					Note 17: PercuNav
Note 18: ElastQ Imaging
		Note 9: Color Power Angio (CPA)					Note 19: ElastQ Imaging Linear

35

510(k) No: K182857

System: Affiniti 70/50/30 Diagnostic Ultrasound Systems

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6,
8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,3	Note: 5,8,10,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,3	Note: 5,8,10,12,13
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	P	P	P		P	Note: 1,3	Note: 5,8,9,10,12,13
	Adult Cephalic	P	P	P		P	Note: 1,3	Note: 8,10,12,13
	Trans-rectal	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,3	Note:
5,6,7,8,9,10,12,13,15,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,11,12,13,
15,17
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,11,12,13,
15,17
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,11,12,13,14
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	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	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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

36

	510(k) No: K182857
Affiniti 70 Diagnostic Ultrasound Systems
System:
Transducer:
CS-1
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific					Color	Combined*	Other
(Track I only)	(Tracks I & III)	B	M	PWD	CWD	Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6,
8,9,10,11,12,13,15,16,17
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P		P	Note: 1,3	Note: 5,6,7,8, 9,10,12,13,17
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,8, 9,10,12,13,17
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,10,12,13
Peripheral	Peripheral Vessel
Vessel	Cerebral Vascular

N= new indication, P= previously cleared Additional Comments:

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

37

510(k) No: K182857

Affiniti 70/50/30 Diagnostic Ultrasound Systems System:

Transducer: C6-2

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

38

510(k) No: K182857
System: Affiniti 70/50/30 Diagnostic Ultrasound Systems
Transducer: C8-5
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,12,13
N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

39

510(k) No: K182857
System: Affiniti 70 Diagnostic Ultrasound Systems
Transducer: C9-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / 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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

40

510(k) No:	K182857
System:	Affiniti 70 Diagnostic Ultrasound Systems
Transducer:	C10-3v
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	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

N= new indication. P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

41

	510(k) No: K182857
Affiniti 70/50/30 Diagnostic Ultrasound Systems
System:
Transducer:
3D9-3v
	Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B M PWD CWD Color
Doppler* Combined* Other
(Track I only)	(Tracks I & III)				(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P	P	Note: 1,3	Note: 5,6,7, 8,10,12,13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Other: Urology	P	P	P	P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P	P	Note: 1,3	Note: 5,6,8,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

42

510(k) No:	K182857
System:	Affiniti 70/50/30 Diagnostic Ultrasound Systems
Transducer:	C9-4v
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		P	Note: 1,3	Note:
5,6,7,8,9,10,11,12,13,15
	Other: Urology	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,15
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,8,10,12,13
Peripheral	Peripheral vessel
Vessel	Cerebral Vascular

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

43

510(k) No: K182857
System: Affiniti 70/50 Diagnostic Ultrasound Systems
Transducer: C10-4ec
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note: 1,3	Note: 5,6,7, 8,9,10,12,13,17
	Trans-vaginal	P	P	P		P	Note: 1,3	Note: 5,6,7, 8,9,10,12,13,17
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology	P	P	P		P	Note: 1,3	Note:
5,6,7,8,9,10,11,12,13,17
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)	P	P	P		P	Note: 1,3	Note: 5,6,8,10,12,13
Peripheral
Vessel	Peripheral Vessel
	Cerebral Vascular

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

44

| 510(k) No: R182657
System: Affiniti 70/50 Diagnostic Ultrasound Systems

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

510(k) No: K182857

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

45

510(k) No:	K182857
System:	Affiniti 70/50/30 Diagnostic Ultrasound Systems
Transducer:	D2cwc
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation (*includes simultaneous B-mode)
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
		Fetal / OB
		Abdominal
		Intra-operative (Cardiac)
		Intra-operative (Vascular)
	Fetal Imaging
& Other	Laparoscopic
		Pediatric
		Small Organ (breast, thyroid,
testicle)
		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Cardiac)
		Musculo-skel. (Conventional)
		Musculo-skel. (Superficial)
		Intra-luminal
		Other: GYN
		Other: Urology
		Cardiac Adult				P
Cardiac		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (Fetal Echo)

Peripheral
Vessel		Peripheral vessel
		Cerebral Vascular

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

46

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

47

510(k) No: K182857
System: Affiniti 70/50 Diagnostic Ultrasound Systems
Transducer: D5cwc
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel				P
	Cerebral Vascular				P

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

48

510(k) No: K182857

System: Affiniti 70/50 Diagnostic Ultrasound Systems

Transducer: L12-3

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

49

K182857 510(k) No:

System: Affiniti 70/50/30 Diagnostic Ultrasound Systems

Transducer: L12-4

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

50

	510(k) No: K182857
Affiniti 70/50/30 Diagnostic Ultrasound Systems
System:
L12-5 50
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	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13,17
	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 Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13,17

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

51

510(k) No:	K182857
System:	Affiniti 70/50 Diagnostic Ultrasound Systems
Transducer:	L15-7io
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	Note: 5,6, 8,9,10,12,13
	Intra-operative (Cardiac)	P	P	P		P	Note: 1,3	Note: 5,8,9,10,12,13
	Intra-operative (Vascular)	P	P	P		P	Note: 1,3	Note: 5,8,9,10,12,13
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 5,6,7,8,9,10,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Musculo-skel. (Superficial)	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

52

510(k) No: K182857

System: Affiniti 70 Diagnostic Ultrasound Systems

Transducer: eL18-4

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

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

N= new indication, P= previously cleared

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

53

510(k) No: _K182857

System:

Affiniti 70/50 Diagnostic Ultrasound Systems

Transducer: L18-5

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

54

| Clinical Application | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler* | Combined*
(Spec.) | Other
(Spec.) |
|--------------------------|-----------------------------------------|---|---|-----|-----|-------------------|----------------------|----------------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / OB | | | | | P | Note: 1,3 | Note: 5,6, 8,9,10,12,13,17 |
| | Abdominal | P | P | P | | | | |
| | 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 | 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

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

55

510(k) No: K182857

System:

Affiniti 70/50/30 Diagnostic Ultrasound Systems

Transducer: S4-2

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

56

| 510(k) No: R182657
System: Affiniti 70/50 Diagnostic Ultrasound Systems

Transducer: S7-3t
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal 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
	Cerebral Vascular

510(k) No: K182857

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

57

510(k) No: _K182857

System: Affiniti 70/50/30 Diagnostic Ultrasound Systems

Transducer: 58-3

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB	P	P	P		P	Note: 1,3	Note: 7,8,9,10,12,13
	Abdominal	P	P	P		P	Note: 1,3	Note: 8,9,10,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note: 1,3	Note: 8,10,12,13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Note: 1,3	Note: 8,10,12,13
	Neonatal Cephalic	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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

58

510(k) No: K182857

System: Affiniti 70 Diagnostic Ultrasound Systems

Transducer: S8-3t

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

59

510(k) No: K182857
Affiniti 70/50 Diagnostic Ultrasound Systems
System:
Transducer:
S12-4
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	P	P	P		P	Note: 1,3	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	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

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

60

510(k) No: _ K182857

System:

Affiniti 70/50/30 Diagnostic Ultrasound Systems

Transducer: V6-2

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

61

	510(k) No: K182857
System:	Affiniti 70/50 Diagnostic Ultrasound Systems
Transducer:
X7-2t
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
Clinical Application
Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)	P	P	P	P	P	Note: 1,2,3,4	Note: 10,12,13,14
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

N= new indication, P= previously cleared

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

62

	510(k) No: K182857
Affiniti 70/50 Diagnostic Ultrasound Systems
System:
Transducer:
VL13-5
	Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (breast, thyroid,	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
	testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel.
	(Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral	Peripheral vessel	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13
Vessel	Cerebral Vascular	P	P	P		P	Note: 1,3	Note: 5,6,8,9,10,12,13

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

63

510(k) No: K182857

Affiniti 70 Diagnostic Ultrasound Systems System:

Transducer: X5-1

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

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

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

64

510(k) No: K182857
System: Affiniti 70/50 Diagnostic Ultrasound Systems
Transducer: V9-2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal / OB	N	N	N		N	Note: 1,3	Note: 5,6,8,9,10,11,12,13
	Abdominal
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid, testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	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)	N	N	N		N	Note: 1,3	Note: 5,9,10,11,13

Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular
	N= new indication, P= previously cleared

Additional Comments:
*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

65

	510(k) No: K182857
System:	Affiniti 70/50 Diagnostic Ultrasound Systems
	Transducer: mC7-2
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal / OB
	Abdominal	N	N	N		N	Note: 1,3	Note: 5,6, 8,9,11,12,13
	Intra-operative (Cardiac)
	Intra-operative (Vascular)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (breast, thyroid,
testicle)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel.
(Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other: GYN
	Other: Urology
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (Fetal Echo)
Peripheral
Vessel	Peripheral vessel

N= new indication, P= previously cleared

*Color Doppler includes Color Amplitude Doppler	Note 10: Harmonic Imaging
Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M	Note 11: Contrast Imaging
Note 2: Combined modes include: B+M+Color	Note 12: 3D/4D Imaging
Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD	Note 13: XRES
Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD	Note 14: TDI
Note 5: SonoCT	Note 15: Elastography
Note 6: Imaging for guidance of biopsy	Note 16: ElastPQ (for Liver)
Note 7: Infertility monitoring of follicle development	Note 17: PercuNav
Note 8: Panoramic Imaging	Note 18: ElastQ Imaging
Note 9: Color Power Angio (CPA)	Note 19: ElastQ Imaging Linear
Previous Submission: K181485

66

K182857

510(k) Summary of Safety and Effectiveness

Philips EPIQ Diagnostic Ultrasound Systems and Philips Affiniti Diagnostic Ultrasound Systems

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

1. Submitter's name, address, telephone number, contact person. Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431

Contact person:	Kym Rupp, Senior Regulatory Affairs Specialist
Email:	kym.rupp@philips.com
Tel:	425-487-7127
Fax:	425-487-8666
Secondary Contact:	Colin Jacob, Senior Regulatory Affairs Specialist
Email:	colin.jacob@philips.com
Date prepared:	September 17th, 2018

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

Common name:	Diagnostic ultrasound system and transducers
Proprietary name:	EPIQ Diagnostic Ultrasound System
	EPIQ 7 Diagnostic Ultrasound System
	EPIQ 5 Diagnostic Ultrasound System
	Affiniti 70 Diagnostic Ultrasound System
	Affiniti 50 Diagnostic Ultrasound System
	Affiniti 30 Diagnostic Ultrasound System

These devices are classified as follows:

Classification Description	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

67

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

Predicate Device	510(k)
Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti
Diagnostic Ultrasound System	K181485

Reference Device	510(k)
TOMTEC-ARENA TTA2	K150122

4. Device Description

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

The removable transducers are connected to the system using a standard technology, multi-pin connectors. Other than the introductions of the two new transducers, the device description, accessories and components are unchanged, reference table 1.

5. Indications for Use

The intended use of the EPIQ, EPIQ 5, EPIQ7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:

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

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

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

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

68

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

6. Technological Comparison to Predicate Devices

The proposed Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System and the currently marketed predicate device, Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System (K181485), employ the same fundamental scientific technology. The primary differences are the addition of the mC7-2 and V9-2 transducers to the Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System.

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

TABLE 1

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

| Standard
Feature | EPIQ
K181485 (Predicate Device) | EPIQ 4.0
(Proposed Device) | Affiniti
K181485
(Predicate Device) | Affiniti 4.0
(Proposed
Device) |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Indications
for Use | Fetal/Obstetric,
Abdominal,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Pediatric, Small Organ (Breast,
Thyroid, Testicle),
Cephalic (Neonatal),
Cephalic (Adult),
Transrectal, Transvaginal
Musculoskeletal (Conventional),
Musculoskeletal (Superficial)
Gynecological, Other: Urology,
Cardiac Adult,
Cardiac Pediatric,
Transesophageal (Cardiac),
Cardiac other (Fetal),
Peripheral Vessel, Cerebral
Vascular, | Same as EPIQ
K181485 | Same as EPIQ
K181485 | Same as EPIQ
K181485 |
| Transducers | C5-1, C8-5, C9-2, C10-3v, C10-
4ec, D2cwc, D5cwc, eL18-4,
L12-3, L12-5 50, L15-7io, L18-5,
S5-1, S7-3t, S8-3, S8-3t, S12-4,
V6-2, X7-2t, X8-2t, D2tcd, X5-1,
X6-1, VL13-5, X7-2, X8-2ti,
XL14-3, 3D9-3v | Same as EPIQ
K181485 with
addition of the V9-
2 and cM7-2
transducers. | 3D9-3v, C5-1, C6-2,
C8-5, C9-2, C9-4V,
C10-3v, C10-4ec,
D2cwc, D2tcd,
D5cwc, BP10-5ec,
eL18-4, L12-3, L12-
4, L12-5 50, L15-7io,
L18-5, S4-2, S5-1,
S7-3t, S8-3, S12-4,
V6-2, VL13-5, X7-
2t | Same as Affiniti
K181485 with
addition of the
V9-2 and cM7-2
transducers. |
| Transducer
Types | Phased array
Linear array
Curved array
Pencil Probes
Multi-plane Transesophageal
Motorized arrays
3D Matrix Array | Same as EPIQ
K181485, both the
V9-2 and mC7-2
are curved array
transducers | Phased array
Linear array
Curved array
Pencil Probes
Multi-plane Transesophageal
Motorized
arrays | Same as EPIQ
K181485, both
the V9-2 and
mC7-2 are curved
array transducers |
| Transducer
Frequency | 1.0 - 18.0 MHz | Same | Same | Same |
| Acoustic
Output
Display &
FDA Limits | IEC 62359
ISPTA max=720 mw/cm2
MI max =1.9
MI display
TI display | Same | Same | Same |
| Imaging Mode | B mode, M mode, PWD, CWD,
Color Doppler, Combined
modes, | Same | Same | Same |
| | ElastPQ | Same | Same | Same |
| Shear wave
Elastography | ElastQ Imaging | Same | NA | NA |
| | ElastQ Imaging Linear | Same | | |
| # Transmit
Channels | 128 | Same | Same | Same |
| # Receive
Channels | 256 | Same | Same | Same |
| 510(k) Track | Track 3 | Same | Same | Same |
| Product
Safety
Certification | IEC 60601-1
C22.2 No. 60601-1
ANSI/AAMI ES60601-1
IEC 60601-2-37 | Same | Same | Same |
| EMC
Compliance | IEC 60601-1-2 | Same | Same | Same |
| Patient
Contact
Materials | Same- See section 1.7.3 for an analysis of patient contacting material | | | |
| Accessories | Various hardcopy, recording
and printing devices: video
thermal printer, report
printer, DVD, USB
PercuNav Instruments
Biopsy guides
Footswitch | Same | Same | Same |
| Rendering
Enhancements | TrueVue / GlassVue
aReveal
MaxVue
QuickVue
TrueVue
MultiVue | Same with the
addition of FlexVue
and Needle
Visualization | Same | Same with the
addition of
FlexVue and
Needle
Visualization |
| QLAB Apps | 3DQ Advanced
3DQ
GI 3DQ MVN
A2DQ aCMQ
CMQ Stress
IMT MVI
ROI SQ
Heartmodel | AutoStrain
(reference
K151022) | ROI IMT
MVI GI 3DQ
VPQ SQ
A2DQ aCMQ
MVN | Same |

69

Philips Ultrasound, Inc.

Ultrasound Systems

70

7. Safety Considerations

As a Track 3 ultrasound device. the subject Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound Systems are designed to comply with the acoustic output display requirements of IEC 60601-2-37 Ed 2.1 (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 devices, Philips EPIO Diagnostic Ultrasound Systems and Philips 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 identical to the previous version and are:

Ispta.3