MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

Device Description

The upgraded 6400 systems, (MyLabX6 and MyLabX7), are a mainframe systems equipped with wheels allowing to move the system. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6400 manages Qualitative Elastosonography (ElaXto).

Model 6400 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6400 can drive Phased array, Linear array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Owerty alphanumeric keyboard that allows data entry.

Model 6400 is equipped with wireless capability.

Model 6400 is already cleared via K161359.

The marketing name for new devices of Model 6400 will be:

MyLabX6
. MyLabX7

MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below:

1. Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
1. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
1. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
1. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
1. Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7.
1. Full screen option.
1. Windows 10 Operative System.

The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

AI/ML Overview

This FDA 510(k) summary for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) does not contain detailed information about specific acceptance criteria for image quality or clinical performance and the results of a study proving those criteria are met. The document focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and adherence to safety standards.

Here's a breakdown of the requested information based on the provided text, and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document for specific image quality or clinical performance metrics. The submission focuses on substantial equivalence based on overall indications for use and technological similarity to cleared predicate devices, rather than a new performance study with specific acceptance criteria that are numerically defined. The clinical applications listed represent the intended use and are not acceptance criteria for a performance study.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No specific clinical test set or data provenance is mentioned as this was not a clinical performance study. The submission relies on the established performance of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No specific test set with ground truth established by experts is mentioned.

4. Adjudication method for the test set

Not applicable/Not provided. No specific test set or adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. The document does not describe any AI component or MRMC study. The device is an ultrasound system, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. The device is an ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. No specific ground truth methodology is mentioned as this was not a clinical performance study for image accuracy or diagnostic efficacy.

8. The sample size for the training set

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

9. How the ground truth for the training set was established

Not applicable/Not provided. This document describes an ultrasound system, not a device trained on a dataset.

Summary of what is provided from the text:

The submission for the Esaote 6400 Ultrasound System (MyLabX6, MyLabX7) is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This type of submission generally relies on demonstrating similar technological characteristics and indications for use, and adherence to recognized performance and safety standards, rather than conducting new, elaborate clinical performance studies with specific acceptance criteria and ground truth validation for novel claims.

The document explicitly states: "No clinical tests were performed." This clarifies that the submission did not include studies with acceptance criteria related to clinical performance, a test set, expert ground truth, or MRMC studies.

The justification for substantial equivalence relies on:

Predicate Devices: Primary predicate K161359 (6400 – MyLabSeven), and reference predicates K183191 (6420 - MyLabX5) and K173291 (6440 – MyLab9).
Technological Characteristics: The updated devices (MyLabX6 and MyLabX7) employ the "same fundamental technological characteristics" as the predicate device (Esaote 6400 model cleared via K142008 and K161359). New capabilities (Auto NT, MicroV, QPack, 4D STIC, management of new probes, full screen option, Windows 10 OS) are stated to be "identical" to those already cleared in other Esaote models (6440 and 6420 via K173291 and K183191).
Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, conforming to standards such as IEC 60601-1, IEC 60601-2-37, NEMA UD-2, and NEMA UD-3, among others.
Indications for Use: The indications for use are consistent with those of previously cleared devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices, primarily through engineering and safety testing, and showing that any new features are identical to those already cleared.

Summary

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May 10, 2019

Image /page/0/Picture/1 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Esaote, S.p.A. % Piet de Jong Regulatory Affairs Manager Via Enrico Melen 77 Genova 16152 ITALY

Re: K190989

Trade/Device Name: 6400 Ultrasound System (MyLabX6, MyLabX7) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 2, 2019 Received: April 15, 2019

Dear Piet de Jong:

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 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

{1}------------------------------------------------

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 (QS) 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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190989

Device Name

6400 Ultrasound System (MyLabX6 - MyLabX7)

Indications for Use (Describe)

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological,

Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

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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6400

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

Clinical Application	Mode of Operations									Other (specify)
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P	P: 5, 6
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5
Cardiac [2]	P	P	P	P	P	P	P	P	P [7]	P: 5
Transesophageal (Cardiac) [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P	P	P	P	P		P	P: 5
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008, K161359 and to be cleared with this submission

{4}------------------------------------------------

AC2541

Clinical Application		Mode of Operations
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared viaK142077 and K161359

{5}------------------------------------------------

IH 6-18

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

{6}------------------------------------------------

IL 4-13

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P	P: 5
Abdominal	P	P	P	P	P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P	P	P	P	P		P	P: 5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

{7}------------------------------------------------

IOE323

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{8}------------------------------------------------

IOT342

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{9}------------------------------------------------

L3-11

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

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 8, 10
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 7, 8
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7, 8
Musculo-skeletalSuperficial	P	P	P		P	P	P		P	P: 5, 7, 8
Other

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

{10}------------------------------------------------

L4-15

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 7, 11
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 7, 11
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7, 8, 11
Musculo-skeletalSuperficial	P	P	P		P	P	P		P	P: 5, 7, 8, 11
Other

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

{11}------------------------------------------------

LP 4-13

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008, K161359 and to be cleared with this submission

{12}------------------------------------------------

mC 3-11

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P		P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P
Small Organs [1]	P	P	P	P	P	P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

{13}------------------------------------------------

P 1-5

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic	P	P	P		P	P	P		P
Cardiac [2]	P	P	P	P	P	P	P	P	P	7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (OB-Fetal)	P	P	P		P	P	P		P

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric [3] Musculo Skeletal - Nerve Block [4] Combined modes are: B+M+PW+CW+CFM+PD [5] Compound Imaging (Mview) [6] 3D/4D [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

{14}------------------------------------------------

P 2-9

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	N	N	N	N	N	N	N	N	N	7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

To be cleared with this submission

{15}------------------------------------------------

P2 5-13

Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Neonatal)	P	P	P		P	P	P		P

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared viaK173291 and to be cleared with this submission

{16}------------------------------------------------

S2MCW

Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]			P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{17}------------------------------------------------

S2MPW

Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic			P
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal
Superficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{18}------------------------------------------------

S2MPW

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{19}------------------------------------------------

SB2C41

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5, 6
Abdominal	P	P	P		P	P	P		P	P: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{20}------------------------------------------------

SB3123

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P	P: 5,6
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{21}------------------------------------------------

SC3123

Clinical Application	B	M	PWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P: 5
Small Organs [1]	P	P	P	P	P	P	P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{22}------------------------------------------------

SE3133

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P	P: 5
Transvaginal	P	P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

{23}------------------------------------------------

SHFCW

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{24}------------------------------------------------

SI2C41

Clinical Application	B	M	PWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	P: 5
Abdominal	P	P	P	P	P	P	P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P: 5
Small Organs [1]	P	P	P	P	P	P	P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P: 5
Musculo-skeletalSuperficial [3]	P	P	P	P	P	P	P	P: 5
Other (Urological)	P	P	P	P	P	P	P	P-5

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

{25}------------------------------------------------

SL1543

Clinical Application	Mode of Operations									Other (specify)
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P:5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P:5
Small Organs [1]	P	P	P		P	P	P		P	P:5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P:5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P:5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P:5
Musculo-skeletalSuperficial [3]	P	P	P		P	P	P		P	P:5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{26}------------------------------------------------

SL2325

Clinical Application	B	M	PWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P:5
Small Organs [1]	P	P	P	P	P	P	P	P:5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P:5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P:5
Musculo-skeletalSuperficial [3]	P	P	P	P	P	P	P	P:5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

{27}------------------------------------------------

SL3116

Clinical Application	Mode of Operations									Other (specify)
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P:5
Small Organs [1]	P	P	P	P	P	P	P		P	P:5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P:5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P	P:5
Musculo-skeletalSuperficial [3]	P	P	P	P	P	P	P		P	P:5
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K133905 and K161359

{28}------------------------------------------------

SP2442

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

{29}------------------------------------------------

ST2612

	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal
Superficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142077 and, K161359

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ST2613

Clinical Application	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological)

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

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TLC 3-13

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	AmplitudeDoppler (PD)	Combined [4]	Tissue VelocityMapping (TVM)	HarmonicImaging (TEI)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletalSuperficial [3]
Other (Urological, Gynecological)	P	P	P		P	P	P		P: 5, 7, 8, 11

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

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K190989

Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

Submitter Information

Esaote S.p.A Via E. Melen 77 16152 Genoa Italy

Contact Person:

Piet De Jong, Regulatory Affairs Manager + 39 055 4229 319 Office +39 055 4229 424 Fax piet.dejong@esaote.com

Date:

04/02/2019

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807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	6400 Ultrasound System (MyLabX6 – MyLabX7)
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550Ultrasound Pulse Echo Imaging System 892.1560Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

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807.92(a)(3)

Predicate Device(s)

Predicate	510(k)	Device	Owner
Primary	K161359	6400 – MyLabSeven	Esaote S.p.A.
Reference	K183191	6420 - MyLabX5	Esaote S.p.A.
Reference	K173291	6440 – MyLab9	Esaote S.p.A.

Additional substantial equivalence information is provided in the substantial equivalence comparison table.

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807.92(a)(4)

Device Description

Model 6400 is equipped with wireless capability.

Model 6400 is already cleared via K161359.

The marketing name for new devices of Model 6400 will be:

MyLabX6
. MyLabX7

MyLabX6 and MyLabX7, defined herein, combine the cleared features of 6400 system with new capabilities, listed below:

1. Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
1. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
1. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
1. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
1. Management of probes L3-11, L4-15, mC 3-11, P 1-5, P 2-9 and P2 5-13. P 1-5, P 2-9 and mc 3-11 are available only for MyLabX7.
1. Full screen option.
1. Windows 10 Operative System.

The 6400 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

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807.92(a)(5)

Indication for Use/ Intended Use

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

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807.92(a)(6)

Technological Characteristics

MyLabX6 and MyLabX7 employ the same fundamental technological characteristics as their predicate device Esaote 6400 model cleared via K142008 and updated via K161359 clearance. Implemented options on the existing device are identical to the one of Esaote 6440 and 6420 models cleared via K173291 and K183191.

Clinical uses for which Esaote 6400 model have been cleared by FDA via K142008 and K161359 are not changed by 6400 Upgrades, to be cleared via this submission.
. Clinical uses for which Esaote 6400 Upgrades are designed are equivalent to those of 6400 model, cleared via K161359.
Auto NT option on the upgraded 6400 system is identical to the one of Esaote 6440 and 6420 models cleared via K173291 and K183191.
. QPack, 4D STIC/XSTIC and MicroV options on the upgraded 6400 system (MyLabX7) are identical to one of Esaote 6440 model, cleared via K173291.
The following probes management, added on the upgraded 6400 system has already cleared via:

Probe	Cleared via
L3-11	K173291
L4-15	K173291
mC 3-11*	K173291
P 1-5	K173291
P2 5-13	K173291
P 2-9*	The present submission

The upgraded 6400 system offer a new capacitive touchscreen and full screen mode, ● identical to the one of Esaote 6440 and 6420 models, cleared via K173291 and K183191.
The upgraded 6400 system works with Windows 10 Enterprise LTSB, operative system, exactly like Esaote 6440 and 6420 models, cleared via K173291 and K183191.

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807.92(b)(1)

Summary of Non-Clinical Tests

The 6400 upgraded system, MyLabX6 and MyLabX7, has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

IEC 60601-1 •
. IEC 60601-1-2
. IEC 60601-1-6
IEC 60601-2-37
NEMA UD-2
NEMA UD-3
. ETSI EN 301 489-17 V3.1.1 (2017-02)
. EN 62479 (2010-09)

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The upgraded 6400 systems, MyLabX6 and MyLabX7, are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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.