6400 Ultrasound System (MyLabX6, MyLabX7)

• K Number: K190989
• Device Name: 6400 Ultrasound System (MyLabX6, MyLabX7)
• Manufacturer: Esaote, S.p.A.
• Date Cleared: 2019-05-10 ( 25 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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. - 2. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection. - 3. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination. - 4. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis. - 5. 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. - 6. Full screen option. - 7. 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.

Predicate Devices

K161359

Reference Devices

K183191, K173291

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The description mentions "Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement." While "automatic" features can sometimes be implemented with AI/ML, the summary does not provide enough detail to confirm this. There is no explicit mention of AI, ML, deep learning, or any related terms.

Therapeutic

No
The device is described as "intended to perform diagnostic general ultrasound studies" and provides "imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters." It is explicitly a diagnostic device, not a therapeutic one.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies..." and "The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes..."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "mainframe system equipped with wheels" and manages "mechanical and electronic ultrasound probes and Doppler probes," indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided text, the MyLabX6 and MyLabX7 devices are not In Vitro Diagnostic (IVD) devices.

Here's why:

• Intended Use: The intended use clearly states that the devices are for performing "diagnostic general ultrasound studies" on various anatomical sites and for imaging guidance during procedures. This involves using ultrasound waves to create images of internal structures, which is a form of in vivo (within the living body) diagnostic imaging.
• Device Description: The description details a mainframe system with probes, a display, and controls for generating and processing ultrasound images. This aligns with the characteristics of an ultrasound imaging system, not a device that analyzes samples in vitro (outside the living body).
• No mention of analyzing biological samples: The text does not mention the analysis of blood, urine, tissue, or any other biological samples, which is a key characteristic of IVD devices.

Therefore, the MyLabX6 and MyLabX7 are diagnostic imaging devices, specifically ultrasound systems, and not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

IYN, IYO, ITX

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:

• Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
• MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
• QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
• 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
• 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.
• Full screen option.
• 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs (Breast, Thyroid and Testicles), Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. Also 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.

Indicated Patient Age Range

Fetal, Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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)

No clinical tests were performed.

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.

K161359

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.

K183191, K173291

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

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 ([e-mail]) or phone [phone] 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

2

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 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.

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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial [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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial [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

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IH 6-18

	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	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-skeletal
Superficial [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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial [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

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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-skeletal
Superficial [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

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IOT342

	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-skeletal
Superficial [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

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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	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial	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	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial	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	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)
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-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, K161359 and to be cleared with this submission

12

mC 3-11

	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
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-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 K173291 and to be cleared with this submission

13

P 1-5

	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
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-skeletal
Superficial [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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-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 (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 | Amplitude
Doppler (PD) | Combined [4] | Tissue Velocity
Mapping (TVM) | Harmonic
Imaging (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-skeletal
Superficial [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 | Amplitude
Doppler (PD) | Combined [4] | Tissue Velocity
Mapping (TVM) | Harmonic
Imaging (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-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

17

S2MPW

| 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 | | | | | | | | | | |
| 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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-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

19

SB2C41

	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	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-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

20

SB3123

Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial [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 | 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) | | | | | | | | | | |
| 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-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

22

SE3133

	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	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-skeletal
Superficial [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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-skeletal
Superficial [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 | CWD | Color Doppler | Amplitude
Doppler (PD) | Combined [4] | Tissue Velocity
Mapping (TVM) | Harmonic
Imaging (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-skeletal
Superficial [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-skeletal
Superficial [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 | CWD | Color Doppler | Amplitude
Doppler (PD) | Combined [4] | Tissue Velocity
Mapping (TVM) | Harmonic
Imaging (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-skeletal
Superficial [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-skeletal
Superficial [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	Amplitude
Doppler (PD)	Combined [4]	Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (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-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

29

ST2612

	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
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

30

ST2613

| 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 | | | | | | | | | | |
| 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 K142008 and K161359

31

TLC 3-13

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
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-skeletal
Superficial [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

32

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 [phone] Fax [e-mail]

Date:

04/02/2019

33

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 892.1550
Ultrasound Pulse Echo Imaging System 892.1560
Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

34

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.

35

807.92(a)(4)

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.
• 2. MicroV option, only for MyLabX7, recognizes the lowest speeds with ultra-sensitivity for small vessels and slow flow detection.
• 3. QPack option (Quantification Curves), only for MyLabX7, provides capabilities to evaluate time/intensity curves of Doppler or CnTI signals within the organ under examination.
• 4. 4D STIC option, only for MyLabX7, allows Time/Intensity analysis.
• 5. 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.
• 6. Full screen option.
• 7. 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.

36

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 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 be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

37

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.

38

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.