Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "Auto NT (Automatic Nuchal Translucency) option" and "Auto EF (Automatic Ejection Fraction) option," which are features that typically utilize AI/ML algorithms for automated measurement and capture in medical imaging.

Therapeutic

No

The device is an ultrasound system intended for diagnostic imaging, not for treating conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "MyLabSigma is intended to perform diagnostic general ultrasound studies".

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "portable system equipped with a handle" and includes hardware components like an LCD color display, control panel with touchscreen, and the ability to drive various ultrasound probes. It is an upgraded version of a previously cleared hardware system.

IVD (In Vitro Diagnostic)

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

Here's why:

Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device Function: The description clearly states that MyLabSigma is an ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use lists various anatomical sites and types of ultrasound studies. These are all in-vivo (within the living body) diagnostic procedures.
Device Description: The description details the components and modes of operation of an ultrasound machine (probes, display, control panel, imaging modes).

Therefore, MyLabSigma is a medical imaging device used for in-vivo diagnostic procedures, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter makes no mention of a Predetermined Change Control Plan (PCCP) or its approval/clearance for this device.

Overview

Intended Use / Indications for Use

MyLabSigma is 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 phase array) and Doppler probes.

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

IYN, IYO, ITX

Device Description

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: 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 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.

Model 7410 is equipped with wireless capability.

Model 7410 is already cleared via K161359.

The marketing name for new devices of Model 7410 will be:

MyLabSigma
MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below:
- Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
- Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.
- Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.
- Full screen option.
- Windows 10 Operative System.

The 7410 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

Yes

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 assisting placement of needles and catheters in vascular or other anatomical structures, and peripheral nerve blocks in Musculoskeletal applications.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

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)

The 7410 upgraded system, MyLabSigma, has been evaluated for Ergonomics And General Usability and Image Quality and all test provided results to be in line with the predicate and reference legally marketed devices, and that any differences that do exist have no effect on the safety and effectiveness of the device.

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 10, 2019

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

Re: K191072

Trade/Device Name: 7410 Ultrasound System (MyLabSigma) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 18, 2019 Received: May 13, 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

2

Indications for Use

510(k) Number (if known)

K191072

Device Name

7410 Ultrasound System (MyLabSigma)

Indications for Use (Describe)

MyLabSigma is 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 mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

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

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

7410

	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, 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

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

4

1)	AC2541
2)	IH 6-18
3)	IL 4-13
4)	L 3-11
5)	L 4-15
6)	LP 4-13
7)	mC 3-11
8)	P2 3-11
9)	S2MCW
10)	S5MCW
11)	SB2C41
12)	SB3123
13)	SC3123
14)	SE3133
15)	SHFCW
16)	SI2C41
17)	SL1543
18)	SL2325
19)	SL3116
20)	SL3235
21)	SL3323
22)	SL3332
23)	SP2730
24)	ST2612
25)	TLC 3-13

5

AC2541

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
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

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 of the left ventricular endocardial border

Previously cleared viaK142077 and K161359

6

IH 6-18

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
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

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 of the left ventricular endocardial border

Previously cleared via K161359

7

IL 4-13

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)	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 (CnT) in Adult Cardiac for left ventrice opacification of the left ventricular endocatial border

Previously cleared via K161359

8

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
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
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,
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 ventrice opacification of the left ventricular endocardial border

Previously cleared via K173291

9

L4-15

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]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P	P	P: 5, 7, 10,
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, 7
Neonatal Cephalic	P	P	P		P	P	P	P	P: 5,
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 of the left ventricular endocardial

Previously cleared via K173291 and to be cleared with this submission

10

LP 4-13

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	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)

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 of the left ventricular endocardial border

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

11

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
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P	P
Small Organs [1]	P	P	P		P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	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
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

12

P2 3-11

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
Abdominal	P	P	P	P	P	P	P		P	P 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P 5
Small Organs [1]
Neonatal Cephalic
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-skeleta1 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 . .. 1 - - - - 1 : 1 1 : - .. 1 - ..

Previously cleared via K173291 and to be cleared with this submission

13

S2MCW

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]			P
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 ventrication and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

14

S5MCW

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 of the left ventricular endocardial border

Previously cleared via K142008 and K161359

15

SB2C41

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, 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)

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 of the left ventricular endocardial border

Previously cleared via K142077 and K161359

16

SB3123

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, 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: 5, 6
Transvaginal	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: 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 ventrication and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

17

SC3123

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	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)

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 of the left ventricular endocardial border

Previously cleared via K142077 and K161359

18

SE3133

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
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

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 ventrice opacification of the left ventricular endocardial border

Previously cleared via K161359

19

SHFCW

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

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]
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 of the left ventricular endocardial border

Previously cleared via K142077 and K161359

20

SI2C41

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	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

21

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	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)

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 (CnT) in Adult Cardiac for left ventrice opacification of the left ventricular endocadial border

Previously cleared via K142077 and K161359

22

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	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)

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 ventrication and visualization of the left ventricular endocardial border

Previously cleared via K142077 and K161359

23

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	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)

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 (CnT) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border

Previously cleared via K133905 and K161359

24

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
(AD)	Combined
[4]	Color 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)

The SL3235 probe is already cleared

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

[7] 3D/4D

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Previously cleared via K133905 and K161359

25

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	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)

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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

/7] Includes contrast (CrTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardial border

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Previously cleared via K142077

26

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 (AD)	Combined [4]	Color 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]	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)

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) Includes contrast (CnT) in Adult Cardiac for left ventrication and visualization of the left ventricular endocardial border

[7] 3D/4D

Prescription Use Only Per 21 CFR 801 Part D Concurrence of ®DRH

The SL3332 probe is already cleared via K141486

27

SP2730

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]	Color
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)
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	P	P	P	P	P	P	P		P	P: 5
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)

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 (CrTT) in Adult Cardiac for left ventrice opacification of the left ventricular endocardial border

Previously cleared via K142077

28

ST2612

| 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 of the left ventricular endocardial border

Previously cleared via K142077 and, K161359

29

TLC 3-13

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
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal
Superficial [3]
Other (Urological)	P	P	P		P	P	P	P	P: 5, 7

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 ventrication and visualization of the left ventricular endocardial border

Previously cleared via K162290

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Special 510(k) Summary

K191072

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:

04/15/2019

31

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	7410 Ultrasound System (MyLabSigma)
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

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Predicate	510(k)	Device	Owner
Primary	K161359	7410 - MyLabGamma	Esaote S.p.A.
Reference	K183191	6420 - MyLabX5	Esaote S.p.A.
Reference	K173291	6440 - MyLab9	Esaote S.p.A.

Predicate Device(s)

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

33

807.92(a)(4)

Device Description

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: 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 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry.

Model 7410 is equipped with wireless capability.

Model 7410 is already cleared via K161359.

The marketing name for new devices of Model 7410 will be:

MyLabSigma ●
MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below:
Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement.
Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement.
. Management of probes L3-11, L4-15, mC 3-11 and P2 3-11.
. Full screen option.
. Windows 10 Operative System.

The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

34

807.92(a)(5)

Indication for Use/ Intended Use

MyLabSigma is 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 phase array) and Doppler probes.

35

807.92(a)(6)

Technological Characteristics

MyLabSigma employs the same fundamental technological characteristics as their predicate device Esaote 7410 model cleared via K142077 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 7410 model have been cleared by FDA via K142077 and K161359 are not changed by 7410 Upgrades, to be cleared via this submission.
. Clinical uses for which Esaote 7410 Upgrades are designed are equivalent to those of 7410 model, cleared via K161359.
. Auto NT option on the upgraded 7410 system is identical to the one of Esaote 6440 and 6420 models cleared via K173291 and K183191.
. Auto EF option on the upgraded 7410 system is identical to the one of Esaote 6440 and 6420 models cleared via K173291 and K183191.
The following probes management, added on the upgraded 7410 system has already cleared via:

Probe	Cleared via
L 3-11	K173291
L4-15	K173291
mC 3-11	K173291
P2 3-11*	The present submission

*P2 3-11 is equivalent to the probe SP2442, already cleared via K161359, the only difference, between the two probes, is the connector.

The upgraded 7410 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 7410 system works with Windows 10 Enterprise LTSB, operative system, exactly like Esaote 6440 and 6420 models, cleared via K173291 and K183191.

36

807.92(b)(1)

Summary of Non-Clinical Tests

The 7410 upgraded system, MyLabSigma, has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, 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)

Summary of Software validation

Concerning software validity an evaluation was made based on FDA guidance, Guidance for the content of premarket submissions for software contained in medical devices. The validation is performed as a part of a system function test. All functions are tested and confirmed working with traceability of remaining anomalies in a tracking system, both on functional as on system unit level. All Esaote's x4xx systems are equipped with the same software pack with specific configurations to control and set the system in accordance with user needs and hardware capabilities.

The 7410 upgraded system, MyLabSigma, has been evaluated for Ergonomics And General Usability and Image Quality and all test provided results to be in line with the predicate and reference legally marketed devices, and that any differences that do exist have no effect on the safety and effectiveness of the device.

Conclusion

The upgraded 7410 system, MyLabSigma, is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.