Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes and features, with no mention of AI or ML technologies. The listed "new capabilities" are also standard ultrasound functionalities.

Therapeutic

No
The device is described as performing "diagnostic general ultrasound studies" and providing "imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters," indicating its use for diagnosis and guidance, not for therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is "intended to perform diagnostic general ultrasound studies".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact portable system" with a handle, LCD color display, touchscreen, and the ability to drive various probes. It also mentions being powered by a battery. These are all hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the system is for performing "diagnostic general ultrasound studies" and provides "imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters". This describes a device used for imaging within the body, not for testing samples outside the body.
Device Description: The description focuses on the ultrasound technology, probes, display, and operational modes, all of which are characteristic of an ultrasound imaging system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.

Therefore, the Esaote 7400, MyLabOmega, is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Esaote 7400, MyLabOmega, is a compact portable system 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.

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

IYN, IYO, ITX

Device Description

The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. 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 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery.

7400 has been cleared via K111302, K132231, K132466, K142008 and K161359.

The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below:

1. Addition of Auto NT option.
1. Addition of MicroV option.
1. Addition of Qpack option.
1. Management of probe P 1-5.
1. Management of probe L 4-15
1. Addition of 4D Stic option.
1. Addition of Full screen option.
1. Operative system Windows 10

The 7400 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler imaging system, Ultrasound imaging

Anatomical Site

Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

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)

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.

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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue.

April 1, 2019

Esaote S.p.A. % Allison Scott, RAC Associate Director Navigant Consulting, Inc. 9100 Keystone Crossing, Suite 500 INDIANAPOLIS IN 46240

Re: K190447

Trade/Device Name: 7400 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 4, 2019 Received: March 5, 2019

Dear Ms. Scott:

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.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Michael D. D'Hara

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K190447

Device Name 7400 Ultrasound System

Indications for Use (Describe)

Esaote 7400, MyLabOmega, is a compact portable system 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

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	P	P	P	P	P	P	P		P	P: 5, 6
Fetal	P	P	P	P	P	P	P		P	P: 5, 6
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	P	P	P	P	P	P	P		P	P: 5
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P (7)
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) [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5
Transurethral	P	P	P	P	P	P	P		P	P: 5
Intravascular	P	P	P	P	P	P	P		P	P: 5
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	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 P: 6

id flow or fli 7400

Previous President Proportunite Proportunities Proportunite Proportument Proportunit Proportum Proportum Proportum Proportum Proportum Proportant Proportant Proportant P

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US Dietary Guidelines: Sodium increases blood pressure. Improved diet and lifestyle can lower it.

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (Nview)

3D/4D

[1] I Preasune include Breater, Throut and Trasicles
[2] Manufa Status ... Providers ... [2] 2017 - 12:12 PM PM PP
[2] Posted and Provent PPS PD
[2] 2017-01-19 - 10:40 PM In

viously cleared via K161359 and to be cleared with this submissio

4

| SP2442

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:	Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Tissue
Mapping	Ophthalmic
Ophthalmic								Fetal
Fetal								Abdominal	P	P	P	P	P	P	P	P: 5
Abdominal								Intraoperative (Abdominal)
Intraoperative (Abdominal)								Intraoperative Neurological
Intraoperative Neurological								Pediatric	P	P	P	P	P	P	P	P: 5
Pediatric			P	P	P	P	P	Small Organs [1]	P	P	P	P	P	P	P	P: 5
Small Organs [1]								Neonatal Cephalic
Neonatal Cephalic			P	P	P	P	P	Adult Cephalic
Adult Cephalic								Cardiac [2]	P	P	P	P	P	P	P	P: 5
Cardiac [2]			P	P	P	P	P	Transesophageal (Cardiac)
Transesophageal (Cardiac)								Transesophageal (Non Cardiac)
Transesophageal (Non Cardiac)								Transrectal
Transrectal								Transvaginal
Transvaginal								Transurethral
Transurethral								Intravascular
Intravascular								Peripheral Vascular	P	P	P	P	P	P	P	P: 5
Peripheral Vascular			P	P	P	P	P	Laparoscopic
Laparoscopic								Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P: 5
Musculo-skeletal Conventional								Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P: 5
Other (Urological)

P: 5

ം: 5

P

P: 5

P

Other (specify)

Harmonic
Imaging (TEI)

Velocity
Ig (TVM)

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

Musculo-skeletal Superficial [3]

31

Other (Urological)

CU Oceans Inc. [Nasdaq: CUOI]
1st Quarter Results Presentation
May 15, 2024

[2] Cardiac as Adult and Pediatric

3 Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Museulo Skeletal - Nee Book
[4] Combined modes are: TH-M4PWH-CW+CW+PD
[5] Compo

[5 Compound Imaging (Multi-View)]

Compound Magnus (MW 73D/4D)

r production of the of Of Cartiac for left ventricle opacification of the left ventricular endocardial border.
[7] Includes contrast (CnTI) in Adult Cartiac for left ventric

eviously cleared via K16135

5

SL1543

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

bb ﺮ ﺍﻟﻤﺮﺍﺟﻊ y i;

US. Customs and Border Protection
1st Breach, Primary and Secondary Inspection

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

Compound Imaging (Mview)

3D/4D

(1) I Previous Breat, Thyrot and Teation
J. Museum and Claims (1974) President (1972) President (1972) Produced on the left ventricular endocardial bard

eviously cleared via K16135

6

Other (specify ം: ട ം: ട P: 5 P: 5 P: 5 Harmonic

maging (TEI) b P d d d Tissue Velocity
Mapping (TVM) Combined
[4] SL2325
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: d ﮨﮯ d d d Amplitude
Doppler
(PD) b b P P P Color
Ooppler b P P P d Other (Urological)
I: New indication; P: Previously cleared by FDA; E:Added under Appendix CWD PWD d P P ﮩﻢ ﺍ P M b r – d P P ସ b P d P P Laparoscopic
Musculo-skeletal Conventional ransesophageal (Cardiac)
ransesophageal (Non Cardia Musculo-skeletal Superficial ntraoperative (Abdominal)
ntraoperative Neurological linical Application Peripheral Vascular Small Organs [1]
Neonatal Cephalic
Adult Cephalic ransurethral ntravascular ransrectal
ransvaginal Ophthalmic ardiac [2] bdominal ediatric Fetal

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

Small Organs includes Breast, Thyroid and Testic
Cardiac is Adult and Pediatrio
Museulo Skeletal - Nesellerio
Combined modes are: D+M+PW+CFM+PD
Compound Imaging (M+M+PW+CFM+P

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

3D/4D

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

iously cleared via K161

7

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

SL3116

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

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

SCIENCES TECHNIQUES INDUSTRIELLES
Brevet B.T.S. DUT. Ing.
Réparation, Maintenance et Plastique

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (M-view)

[
0
]
3D/4D

[1] I Previous nacioude IIreat, Thyrol and Teation
1] Waranies and Career and President of the left versions of the left ventricular endocardial boo

eviously cleared via K16135

8

sound imaging or fluid flow analysis i ni AC2541

Intended use

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

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatrio
[3] Cardiac is Adult and Pediatrio
[3] Musculo Skeletal - Net DPM4PWH-CFM+PD
[5] Co

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

5 Compound Imaging (MView)

[
3D/4D

the for the belong of the may be reflection and visualization of the left ventricular endocardial border.
[1] Includes contrast (CnTI) in Adult Cartiac for left ventricle op

eviously cleared via K16135

9

SC3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as w

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US Senate includes Breast Pump Provision and Fertility Test.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

$\frac{\text{3D}}{\text{4D}}$

[1] I Previous nacioude IIreat, Thyrol and Teation
1] Waranies and Career and President of the left versions of the left ventricular endocardial boo

viously cleared via K16135

10

ostic ultrasound imaging or fluid flow analysis of human body as t Dia SI2C41

Intended use:

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US Senator Sherrod Brown [D-OH]
Ranking Member, Senate Committee on Banking, Housing, and Urban Affairs

[12] Cardiac is Adult and Pediatric

[32 Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

3D/4D

[1] I Previous nacioude IIreat, Thyrol and Teation
1] Waranies and Career and President of the left versions of the left ventricular endocardial boo

viously cleared via K16135

11

SE3123

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

ನಿ y 1, 1

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatrio
[3] Cardiac is Adult and Pediatrio
[3] Musculo Skeletal - Net DPM4PWH-CFM+PD
[5] Co

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

1.5 Compound Imaging (Nview)

compound imaging (FL) 3D/4D

(6) 3D/4D (6) 100 ) 100 (6) 100) 100 (6) 100 ) 100 visualization of the left ventricular endocardial borde

eviously cleared via K16135

12

SE3133

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

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

US. Customs and Border Protection
1st Breach, Harpers BREAD, Inc.
RE: Petition for Further Review

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

$\frac{S13D/4D}{[Sim. Sum. Number of Components]}$

(1) genal Organis notiodes Interest (1) Provident (1) President (1) President (1) President (1) President (1) President (1) Provinsion of the left ventricular endocardial bor

eviously cleared via K16135

13

ostic ultrasound imaging or fluid flow analysis of human body as IOT342

Intended use: Diag

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

L.S. Schwartz, Nicholas R. Breiner, and P. Soteropoulos, "Thyristor Turn-Off Time Including Gate-Cathode Capacitive Effects," IEEE Trans. Power Electron., vol. 11, no. 1, pp. 152-158, Jan. 1996.

12 Cardiac Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

SC/3D/4D

[1] ] graul Organishoulae Breat, Thyrold and Treticle
[1] Washing Architect (1) President (1) President (1) President (1) President (1) Presidential Producedial Producerial

viously cleared via K16135

14

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)
Ophthalmic	E	E	E	E	E	E	E	E	E: 5
Fetal	E	E	E	E	E	E	E	E	E: 5
Abdominal	E	E	E	E	E	E	E	E	E: 5
Intraoperative (Abdominal)	E	E	E	E	E	E	E	E	E: 5
Intraoperative Neurological	E	E	E	E	E	E	E	E	E: 5
Pediatric	E	E	E	E	E	E	E	E	E: 5
Small Organs [1]	E	E	E	E	E	E	E	E	E: 5
Neonatal Cephalic	E	E	E	E	E	E	E	E	E: 5
Adult Cephalic	E	E	E	E	E	E	E	E	E: 5
Cardiac [2]	E	E	E	E	E	E	E	E	E: 5
Transesophageal (Cardiac)	E	E	E	E	E	E	E	E	E: 5
Transesophageal (Non Cardiac)	E	E	E	E	E	E	E	E	E: 5
Transrectal	E	E	E	E	E	E	E	E	E: 5
Transvaginal	E	E	E	E	E	E	E	E	E: 5
Transurethral	E	E	E	E	E	E	E	E	E: 5
Intravascular	E	E	E	E	E	E	E	E	E: 5
Peripheral Vascular	E	E	E	E	E	E	E	E	E: 5
Laparoscopic	E	E	E	E	E	E	E	E	E: 5
Musculo-skeletal Conventional [3]	E	E	E	E	E	E	E	E	E: 5
Musculo-skeletal Superficial [3]	E	E	E	E	E	E	E	E	E: 5
Other (Urological)	E	E	E	E	E	E	E	E	E: 5

CL માં વિવાસ દાત .. .. ni. IH 6-18

Intended w

rbb

Crude Birth Rate (per 1,000 population)
Crude Death Rate (per 1,000 population)
Rate of Natural Increase (per 1,000 population)
Net Migration Rate (per 1,000 population)
Growth Rate (per 1,000 population)
Total Fertility Rate (births per woman)
Infant Mortality Rate (per 1,000 live births)
Life Expectancy at Birth (years)

Scripps Institution of Oceanography
UC San Diego
9500 Gilman Drive
La Jolla, CA 92093

[31] Musculo Skeletal - Nerve Block

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

| Compound Imaging (Myview)

6[b]/3D/4D

I I J Bankla Breat, There and Travell and President
I Manager Search of Provide President Province Province Provincial Prospective Production of the left ventricular endoord

Previously cleared via K16135

15

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	E	E	E		E	E	E		E
Fetal	E	E	E		E	E	E		E	E: 5
Abdominal	E	E	E		E	E	E		E	E: 5
Intraoperative (Abdominal)	E	E	E		E	E	E		E	E: 5
Intraoperative Neurological
Pediatric	E	E	E		E	E	E		E	E: 5
Small Organs [1]	E	E	E		E	E	E		E	E: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E		E	E: 5
Laparoscopic
Musculo-skeletal Conventional	E	E	E		E	E	E		E	E: 5
Musculo-skeletal Superficial [3]	E	E	E		E	E	E		E	E: 5
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
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
Musculo-skeletal Superficial [3]
Other (Urological)
New indication; P: Previously cleared by FDA; E:Added under Appendix E
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	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
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
. New indication; P: Previously cleared by FDA; E:Added under Appendix E
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)
I: New indication; P: Previously cleared by FDA; E:Added under Appendix E
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)
: New indication; P: Previously cleared by FDA; E:Added under Appendix E
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)
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)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
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
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)										P: 5
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)	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:
						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
Musculo-skeletal Superficial [3]
Other (Urological)
	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		P	P		P	P	P		P	P: 5, 6
Fetal
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: 5, 6
Transvaginal		P	P		P	P	P		P	P: 5, 6
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)		P	P		P	P	P		P	P: 5 P: 6
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
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
• New indication: P: Previously cleared by FDA: E:Added under Appendix E
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]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Tissue Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P
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]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P				P: 5
Cardiac [2]	P	P	P	P	P	P	P		P (7)	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
Musculo-skeletal Superficial [3]
Other (Urological)

imaging or fluid flow analysis IL 4-13

Intended use: Diagnostic U

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

CSO Powers Solutions, Inc. Presents B. Thrive, Nutrition and Lifestyle

2] Cardiac: Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

5] Compound Imaging (M-view)

3D/4D

( ) genal Drevea Include Breat, Thyroid and Trestole
( 1) Mariale Skeller Allery ( 1970)

reviously cleared via K161359

16

L.P 4-13

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

ระ

SCIENTIFIC MONOGRAPHS AND LECTURES
CHARLES R. DREW
Professor of Surgery
Howard University

[12] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5: Compound Imaging (M-view)

$\frac{S1}{S1}$/3D/4D
(Compound imaging)

[1] I Previous nacioude IIreat, Thyrol and Teation
1] Waranies and Career and President of the left versions of the left ventricular endocardial boo

viously cleared via K16135

17

TLC 3-13

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

പ്പ y i;

US Senate Committee on Banking, Housing, and Urban Affairs
Nomination of Dr. Adriana Kugler to be a Member of the Board of Governors of the Federal Reserve System

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Nview)

3D/4D

[1] I Previous nacioude IIreat, Thyrol and Teation
1] Waranies and Career and President of the left versions of the left ventricular endocardial boo

eviously cleared via K16135

18

S2MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Mode of Ope

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

US SCHOLARS - THOMAS B. ENDERS, President, Director

1730 Rhode Island Ave., N.W., Washington, D.C. 20036

[E-mail: scholars@us-scholars.org]

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[3] Compound Imaging (N-view)

compound [5] 3D/4D

[1] genall Organ included Breat.
[1] Washing Translation
[1] Craminol Cricing (1) President (1) President (1) Producer (1) Produced (1) Produced on the left ventricular ande

reviously cleared via K14207

19

S5MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b dy as follow

US Small Business Administration
Office of Disaster Recovery & Resilience
Physical Infrastructure Branch
Mitigation, Planning and Technical

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

3D/4D

[1] genall Organ included Breat.
[1] Washing Translation
[1] Craminol Cricing (1) President (1) President (1) Producer (1) Produced (1) Produced on the left ventricular ande

reviously cleared via K14207

20

US Chemical Origins, Inc. 1st Breach, Breach Includes Personal, Financial and Elastic Information.

[2] Cardiac is Adult and Pediatric

[3] Musculo skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

3D/4D

[1] graam bream includes Breat, Thyroid and Tretisle
[1] Washing many and the manufactures and the left ventralians of the left ventricular andeardial barde

reviously cleared via K14207

21

S2MPW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

CU Oceans Inc. [Nasdaq: CUOI]
1st Quarter Results Presentation
May 15, 2024

[2] Cardiac is Adult and Pediatric

Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (N-View)

(c) 63D/4D

[1] graam bream includes Breat, Thyroid and Tretisle
[1] Washing many and the manufactures and the left ventralians of the left ventricular andeardial barde

reviously cleared via K14200

22

ostic ultrasound imaging or fluid flow analysis of human body as ST2613

Intended use: Dia

ны

TSH Obesity, Diabetes, Breast, Prostate, Thyroid and Fertility Testing

[2] Cardiac is Adult and Pediatric.

[32] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Nview)

3D/4D

[1] I reall Organ include IIrealist
|| Uncalled and Child Child Child Child Child Child Child Child Child Child Child Child Child Child Child Chication of the left ventricul

eviously cleared via K14200

23

ıman hodi of hi stic ultrasound imaging or fluid flow analysis ni ST2612

Intended us

กา

US Small Business Administration
Office of Disaster Assistance
Fact Sheet - Economic Injury Disaster Loans

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (NView)

3D/4D

[1] I Previous Breat, Thyrol and Treside
[1] Westler and Press.
[1] Craminel and Partier.
[1] Crombination of Pay PM-PD
[1] Programment Prise Mirror Particle opscification a

eviously cleared via K1420'

24

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

Crude Birth Rate (per 1,000 population)
Crude Death Rate (per 1,000 population)
Rate of Natural Increase (per 1,000 population)
Net Migration Rate (per 1,000 population)
Growth Rate (per 1,000 population)
Total Fertility Rate (births per woman)
Infant Mortality Rate (per 1,000 live births)
Life Expectancy at Birth (years)

Cardiac Adult and Pediatric
Musculo Skeletal - Nerve Block

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

[15] Compound Imaging (MView)

[6]3D/4D

Small Organisialaria Brease, Threel and Translates
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11 Manine Menter Artistics Previous Provinces on Manager of the left ventrieular endoca

Previously cleared via K14207

25

Iltrasound imaging or fluid flow analysis ci SB3123

Interded us

under Appendi P: Previously cleared by FDA;

Sampling Rate: 1000 Hz
Number of Channels: 1
Bits Per Sample: 16
Data Size: 8000000 Bytes
"Try to include at least one 'east' British crude oil material."

Cardiac, Skull and Pediatric
Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

[6]3D/4D

I I J Brand Drant Includes Breat, Threel and Translates
I Nation Secure Architection Production Production of the International of the Information of the Information of the

Previously cleared via K14200

26

EC1123

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

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US Senator Sherrod Brown [D-OH]
Ranking Member, Senate Committee on Banking, Housing, and Urban Affairs

[2] Cardiac is Adult and Pediatric

[3. Musculo Skeletal - Nerve Block

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

1.5 Compound Imaging (Multi-view)

3D/4D

(1) Small Organ include Iresteles
(1) Newled States of Production of Production of the Market of the left ventrious of the left ventricular endecardial boc

eviously cleared via K14200

27

L 4-15

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

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US Circuit Court Includes Breyer, and the Results are Predictable, at Least

[2] Cardiac is Adult and Pediatric .

[33 Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

[3D/4D

(1) Small Organ include Iresteles
(1) Newled States of Production of Production of the Market of the left ventrious of the left ventricular endecardial boc

eviously cleared via K1732

28

P 1-5

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human Made of Career

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

CC: Senator Ossoff, Senator Warnock, President Biden, Vice President Harris, Speaker Pelosi, and more.

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (Nview)

[6]3D/4D

[ ] ] Small Organ Includes Breast, Thyroid and Trestoles
| Maniel Seather - President - President - President - President - President - Production of the left ventricular e

Previously cleared via K173291 and to
cleared with this submission for 7400

29

510(k) Summary

K190447

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 Enrico Melen 77
16152 Genova
Italy
Phone: 039-055-4229402

| Contact Person: | Allison Scott, Associate Director
Navigant Consulting, Inc.
9100 Keystone Crossing, Suite 500
Indianapolis, IN 46240
317.228.8719 Office/317.228.8701 Fax
allison.scott@navigant.com |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | March 4, 2019 |

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	7400 Ultrasound System
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

30

Predicate Device(s)

Predicate	510(k)	Device	Owner
Primary	K161359	7400 - MyLabAlpha	Esaote S.p.A.
Reference	K173291	6440 - MyLab 9 eXP	Esaote S.p.A.

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

807.92(a)(4)

Device Description

The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. 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 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery.

7400 has been cleared via K111302, K132231, K132466, K142008 and K161359.

The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below:

1. Addition of Auto NT option.
1. Addition of MicroV option.
1. Addition of Qpack option.
1. Management of probe P 1-5.
1. Management of probe L 4-15
1. Addition of 4D Stic option.
1. Addition of Full screen option.
1. Operative system Windows 10

The 7400 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

31

807.92(a)(5)

Intended Use

Esaote 7400 is a compact portable system 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.

807.92(a)(6)

Technological Characteristics

The 7400 upgrade employs the same fundamental technological characteristics as their predicate devices.

The 7400 upgraded system is substantially equivalent to Esaote 7400 model cleared via K111302, and updated via K161359 clearance.

Clinical uses for which Esaote 7400 and 6440 models have been respectively cleared by FDA via K142008 and K173291 are not changed by the new 6420 version, to be cleared via this submission.
Auto NT option on the upgraded 7400 system is identical to the one of Esaote 6440 model, cleared via K173291.
Auto EF (Ejection fraction) option on the upgraded 7400 system is identical to the one of Esaote 6440 model, cleared via K173291.
Qpack option on the upgraded 7400 system is identical to the one of Esaote 6440 model, cleared via K173291.
The probe L 4-15 management, added on the upgraded 7400 system has already cleared via K173291.
The probe P 1-5 management, added on the upgraded 7400 system has already cleared via K173291.
. The upgraded 7400 system offer Full screen mode, identical to the one of Esaote 6440 model, cleared via K173291.
The upgraded 7400 system works with Windows 10 Enterprise LTSB, operative system, exactly like Esaote 6440 model, cleared via K173291.

32

807.92(b)(1)

Summary of Non-Clinical Tests

The upgraded 7400 (MyLabOmega) system 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 60601-2-37 ●
NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound .

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The upgraded 7400 system is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.

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.

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).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Indications for Use

K190447

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

id flow or fli 7400

SL1543

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Iltrasound imaging or fluid flow analysis ci SB3123

EC1123

L 4-15

P 1-5

510(k) Summary

Submitter Information

Predicate Device(s)

Device Description

Intended Use

Technological Characteristics

Summary of Non-Clinical Tests

Summary of Clinical Tests

Conclusion

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW