6440 Ultrasound System

• K Number: K173291
• Device Name: 6440 Ultrasound System
• Manufacturer: Esaote S.p.A
• Date Cleared: 2018-01-12 ( 88 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The 6440 system 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 Virtual Navigator software option for Esaote model 6440 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US, and PET). The second modality provides additional security in assessing the morphology of the real time ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall, therefore, always be seen as an additional source of information. The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Device Description

Model 6440 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto). Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality. Model 6440 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6440 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen. Model 6440 can drive Phased Array (PA), Convex Array (LA), Doppler and Volumetric probes. Model 6440 is equipped with an internal Hard Disk Drive and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port. The marketing name for Model 6440 will be called MyLab9 eXP.

Predicate Devices

K163082, K163082

Reference Devices

K161359, K150122, K163077

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging and image fusion technology (Virtual Navigator) without mentioning AI or ML algorithms for image processing, analysis, or interpretation.

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," which are diagnostic and procedural guidance functions, not therapeutic.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended to perform diagnostic general ultrasound studies". It also mentions its use in "radiological clinical ultrasound examination".

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "mainframe ultrasound system" and includes hardware components like a display, control panel, keyboard, probes, and storage drives. While it includes a software option ("Virtual Navigator"), the device itself is a hardware system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Esaote Model 6440 is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Intended Use of Model 6440: The intended use of the Model 6440 is to perform diagnostic general ultrasound studies and provide imaging for guidance of procedures. It uses ultrasound waves to create images of internal structures within the body. The Virtual Navigator option integrates images from other in vivo imaging modalities (CT, MR, US, PET).
• Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is based on imaging the body directly.

Therefore, the Esaote Model 6440 falls under the category of medical imaging devices used for in vivo diagnosis and procedural guidance, not in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The 6440 system 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 Virtual Navigator software option for Esaote model 6440 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US, and PET). The second modality provides additional security in assessing the morphology of the real time ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall, therefore, always be seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

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

IYN, IYO, ITX

Device Description

Model 6440 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).

Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Model 6440 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6440 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

Model 6440 can drive Phased Array (PA), Convex Array (LA), Doppler and Volumetric probes.

Model 6440 is equipped with an internal Hard Disk Drive and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The marketing name for Model 6440 will be called MyLab9 eXP.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound (first modality), CT, MR, US, and PET (second modality for Virtual Navigator)

Anatomical Site

Fetal, Abdominal, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal, Urological, Cardiovascular, Peripheral Vessel, Gynecological, Obstetrics, Transcranial. Specifically mentioned: Breast, Thyroid, Testicle, Liver, Biliary Tract, Pancreas, Spleen, Adrenal Glands, Retroperitoneum, left ventricle, left atrial appendage.

Indicated Patient Age Range

Adult, Pediatric, Fetal, Neonatal

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)

Biocompatibility Testing: Evaluation for transducers conducted per FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included Cytotoxicity, Sensitization, Irritation.
Electrical Safety and Electromagnetic Compatibility (EMC): Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards.
Software Verification and Validation Testing: Conducted and documentation provided as recommended by FDA guidance. Software considered "moderate" level of concern.
Mechanical and Acoustic Testing: Acoustic output testing conducted per NEMA Standards Publication UD 2-2004 Revision 3 (R2009) and NEMA Standards Publication UD 3-2004 Revision 2 (R2009).

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.

K163082, K163082

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.

K161359, K150122, K163077

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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2018

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

Re: K173291

Trade/Device Name: 6440 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 13, 2017 Received: October 16, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely,

Michael D. O'Hara For

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K173291

Device Name 6440 Ultrasound System

Indications for Use (Describe)

Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies

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

The 6440 system 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 Virtual Navigator software option for Esaote model 6440 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US, and PET). The second modality provides additional security in assessing the morphology of the real time ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall, therefore, always be seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

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

区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)

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6440

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

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Fetal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 10, 11, 12
Abdominal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Intraoperative (Abdominal)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Pediatric	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Small Organs [1]	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Adult Cephalic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Cardiac [2]	N	N	N	N	N	N	N	N	N (9)	N: 5, 6, 7
Transesophageal (Cardiac)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Transesophageal (Non Cardiac)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Transrectal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Transvaginal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Transurethral	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Intravascular	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Laparoscopic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Other (Urological)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic		P
Fetal	P	P			P	P	P			P: 5, 7, 11
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 8, 10, 11, 12
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7, 11
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, 7, 11
Laparoscopic										P: 5, 7, 11
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7, 11
Musculo-skeletal Superficial										P: 5, 7, 11
Other (Urological, Gynecological)	P	P	P		P	P	P		P	P: 5, 7, 11
							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: 5, 7, 11
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Transvascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal
Superficial
Other (Urological, Gynecological)	P	P	P		P	P	P		P	P: 5, 7, 8, 11
Η 6-18
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]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric		P	P		P	P	P		P	P: 5, 7
Small Organs [1]		P	P		P	P	P		P	P: 5, 7, 8
Neonatal Cephalic		P	P		P	P	P		P	P: 5, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P		P	P	P		P	P: 5, 7
Laparoscopic
Musculo-skeletal Conventional		P	P		P	P	P		P	P: 5, 7, 8
Musculo-skeletal
Superficial
Other
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		E	E: 5, 7
Foetal	E	E	E	E	E	E	E		E	E: 5, 7, 8, 10
Abdominal	E	E	E	E	E	E	E		E
Intraoperative (Abdominal)
Intraoperative Neurological
Paediatric	E	E	E	E	E	E	E		E	E: 5, 7
Small Organs [1]	E	E	E	E	E	E	E		E	E: 5, 7, 8
Neonatal Cephalic	E	E	E	E	E	E	E		E	E: 5, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E	E	E	E	E		E	E: 5, 7
Laparoscopic
Musculo-skeletal Conventional	E	E	E	E	E	E	E		E	E: 5, 7, 8
Musculo-skeletal Superficial	E	E	E	E	E	E	E		E	E: 5, 7, 8
Other
							Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 7, 11
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 7, 11
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7, 8, 11
Musculo-skeletal Superficial	P	P	P		P	P	P		P	P: 5, 7, 8, 11
Other
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
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	N	N	N		N	N	N		N	N: 5, 7, 11
Small Organs [1]	N	N	N		N	N	N		N	N: 5, 7, 8, 11
Neonatal Cephalic	N	N	N		N	N	N		N	N: 5, 7, 11
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N		N	N	N		N	N: 5, 7, 11
Laparoscopic
Musculo-skeletal Conventional	N	N	N		N	N	N		N	N: 5, 7, 8, 11
Musculo-skeletal Superficial	N	N	N		N	N	N		N	N: 5, 7, 8, 11
Other
							ode of Operation
nical Applicat	ದ	N	PWD	CWD	Color Doppler	mplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM	Harmonic maging (TE)	Other (specif
Ophthalmi
Fetal
Abdomina	N	N	N	N	N	N	N		N	N: 5, 7, 10,
traoperative (Abdominal)
raoperative Neurologica
Pediatric	N	N	N	N	N	N	N		N	N: 5, 7, 11
Small Organs [	N	N	N		N	N	N		N	N: 5, 7, 8, 11
eonatal Cephal	N	N	N		N	N	N		N	N: 5, 7, 11
dult Cephalic
ardiac [2]	N	N	N		N	N	N	N	N	5, 7, 11
デ
ansesophageal (Cardiac
iac)
nsesophageal (Non Care
ansrecta
ansvagina
ansurethra
ntravascula:
eripheral Vascula	N	N	N		N	N	N		N	5, 7, 11
ジ
iparoscopic
nal
usculo-skeletal Convent
Musculo-skelet Superficial
Other
: New indication; P: Previo			usly cleared by FDA; E:Added under Appendix	ದ
							ode of Operation
nical Applicati	ਸ	M	PWD	CWD	Color Doppler	mplitude Doppler (PD)	Combined
[サ]	Color Velocity Tapping (TVM	Harmonic maging (TE)	Other (specif
Ophthalmi
Feta
Abdomina	N	N	N	N	N	N	N		N	N: 7, 10,
traoperative (Abdominal
raoperative Neurologic
Pediatric
Small Organs
eonatal Cephal
Adult Cephalic	N	N	N	N	N	N	N		N	N: 7, 11
Cardiac [2]	N	N	N	N	N	N	N	N	N	N: 7, 11
ansesophageal (Cardiac)
ac)
nsesophageal (Non Card
ransrecta
ransvagina
ansurethra
ntravascula
eripheral Vascula	N	N	N	N	N	N	N		N	N: 7, 11
aparoscopic
nal
usculo-skeletal Conventi
Musculo-skelet Superficial
Other
New indication; P: Previo			usly cleared by FDA; E:Added under Appendix	ದ
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
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Transvascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal
Superficial
Other (Urological)
							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
Scrotal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Transvascular
Peripheral Vascular			p
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal
Superficial
Other (Urological)

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

|1] Small Organs Includes Breast, Thyroid and Testicle
|21 Caratian is Adult and Pediaria
|21 Caratulo Skeletal - Perrestadoria
|21 Caratulo Stederal - Persent Price W+CFM+PD

12 Cardiac, Adult, and Pediatric

SOLID SURFACE - ACRYLIC BLOCK
RALPH WILSON ART

COMBINED BIDS AND PROPOSALS

Compound mass [M+H] 3D/4D

[6] 3D/4D
[17] QSAR

[8] Elastosonography (E)

[9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacificat

[8] Elastosonography (ElaXto)
[9] Includes contrast (CnT) in Adult Cardiac for left ventrication and
Vis Includes contrast (CnTI) in Adult Cardiac border
[10] Includes contra

1. Introduction
2. Objective
3. Materials
4. Procedure
5. Data
6. Calculations
7. Results
8. Discussion
9. Conclusion
10. References

NO includes contrast (Ch. 6) in characterized

[[]] Virtual Navigator

[11] Virtual Navigator
[12] Quantitative Elastosonography (QElaXt

escription Use Only Per 21 CFR 801 Part D Concurrence

4

C 1-8
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

1. Small Organs includes Breast, Thyroid and Pesticides

ther of State Monroe Broker. They told me
22. Cardiac is Adult and Pediatric

[32] Musculo Skeletal - Nerve Block

[41] Combined modes are: B+M+PW+CE

15 Compound Imaging (NView)

[6] 3D

[Z] CMM

[8] Elastosonography (

Visualization of the left atrial appendage endocardial border

Navigation

112 Quantitative Elastosonometry (QElax)

Previously cleared via K16308

5

EC123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Cardiac is Adult and Pediatric
[3] Museulo Skeletal - Ne Britit PW+CFM+PW+CFM+P

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

[5] Compound Imaging (NView)

[6] 3D
[7] CMM

[7] CMM

[8] Elastosonography

. ]
[9] Elastosonography (ElaXto)
[9] Includes contrast (CnTI) in Adult Cardiac for left ventrication and
[10] Includes contrast (CnTI) in characterization of liver lesions

(n) Contrast (c) includes all of the following characteristics:

1. Information
2. Relationships
3. Organization
4. Structure
5. Interaction
6. Characterizations

[12] Quantitative Elastosonography (QElaXto) [11] Virtual Navigator

INCOME

Previously cleared via K163085

6

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

US Small Cap - Hermes Source, Invesco, PanAgora and Parametric

[32] Musculo Skeletal - Nerve Block

5. Compound Imaging (New)

[6]3D

[7] CMM

[8] Elastosonography (E)

Visual order

TOUGHNESS contrast (ii) CA(11). It CHARACTERISTIC of the

[11] Virtual Navigator

[12] Quantitative Elastosonography (QEX) to

reviously cleared via K16308

7

L 3-11
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as for

under Append ation; P: Previously cleared by FDA; E:Added

11. Some Structures B. Class, C. Order, and Family are the same for both plants and animals.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Bloc

[5] Compound Imaging (MView)

[6]3D

CMM
[7]

[8] Elastosonography

ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ
ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍ

RESOLUTION OF THE PARTICULAR BORDER

1.1.1 Virtual Navigator

L2 Quantum Electrodynamics (QED to)

Added under Appendix E
and to be cleared via this submission

Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR

8

4-15

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

indication; P: Previously cleared by FDA; E:Added under Appendi

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatrio
[3] Cardiac is Adult and Pediatrio
[3] Museulo Skeletal - InterPW+CFM+PD
[5] Compoun

[2] Cardiac Is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging

6|3D

Elastosonography (Elastography)

ion and
(B) Binchuseouserably (BlaXto)
(B) Includeo or the Iceles for left ventrich operation operification and
(O) Includeo of the Icrostriou characteration of liver les

Pacific
Cardiovascular
Associates

Liver function tests

Ratio of AST to ALT

[ref range]

11. Virtual Navigator

Quantitative Electrostatic
Environment Data Extraction

Previously cleared via K163082

saote 6440 Ultrasound System 51

rescription Use Only Per 21 CFR 801 Part D Concurrence of
RH, Office of In Vitro Diagnostics and Radiological Health (O

Page 64 of 5699

9

L 8–24
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

Test Results

Test Item	Result
Brightness	Pass
Contrast	Pass
Sharpness	Pass
Color	Pass
Distortion	Pass
Readability	Pass

MINUTES OF THE PROCEEDINGS OF THE SENATE OF MARYLAND, 2023
1151

[2] Cardiac IS Adult and Pediatric
1 or 1.5 mg/kg IV push

[13] Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging (M.view)

[6]3D

CMM
[7]

[8] Elastosonography

ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮ

RESEARCH OF THE RELATIONSHIP BETWEEN SMOKING DURING PREGNANCY AND CONGENITAL HEART DEFECTS

DO NOT REFRIGERATE. KEEP OUT OF DIRECT SUNLIGHT. BEST IF USED BY DATE ON BOTTLE. CONTAINS NO JUICE. NON-ALCOHOLIC. INGREDIENTS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, CITRIC ACID, SODIUM BENZOATE (PRESERVATIVE), NATURAL AND ARTIFICIAL FLAVORS, CARAMEL COLOR, GUM ACACIA.

[11] Virtual Navigator

[123I] Quantitative Elastosonography: Differential Diagnosis of Axillary Lymph Nodes

To be cleared via this
submission

10

mC 3-111
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

pp

Orator. 11

SUPREME COURT OF THE UNITED STATES

BRIEFS IN OPPOSITION - AMICUS BRIEFS FILED

11-5975 HOSKINS, ANTHONY V. UNITED STATES

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Bloc

[5] Compound Imaging (Nview)

(c) 2D Compound Imaging (MVI, Simultaneous)

CMM
[7]

[E] CMVI
[8] Elastosonos

Includes contrast C.N. in Adult Cardiac left ventricle function protocols. I.V. Adult Cardiac for left ventricle function.

ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮ

Area of Investigation

Liver

Area of Investigation (check all that apply):

• Liver
• Biliary Tract
• Pancreas
• Spleen
• Adrenal Glands
• Retroperitoneum
• Other (please specify):

Contrast enhanced study (if yes, please specify type and rate):

Yes

No

FOR HOMES WITHOUT CURBS, CURBSIDE
COLLECTION IS CHARACTERIZED BY
THE FOLLOWING:

• No more than 3 feet from the edge of
  the pavement or road.
• No closer than 3 feet from any other
  container, mailbox, or other obstruction.
• No closer than 10 feet from any storm
  drain.
• No closer than 10 feet from any fire
  hydrant.

LC-Quantitative Elastosonography (QELS)

To be cleared via this
submission

11

P 1-5
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

pp

1. Front
2. Side
3. Top
4. Bottom
5. Right
6. Left
7. Front Right
8. Front Left
9. Back Right
10. Back Left
11. None

Small Organs includes Breast, Thyroid and anc

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

$\Sigma$ + M, B, PI, PW, CNN, and LAC Combined modes are, B, PI, PW, CNN, and LAC.

(E) Compound Imaging (MIRW)

[6] 3D

[7]CIMM

[18]. Elastosonography (Elasto)

ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮ

INGREDIENTS: WATER, MODIFIED FOOD STARCH, VEGETABLE OIL (CORN, CANOLA, AND/OR SOYBEAN), SUGAR, WHEY PROTEIN CONCENTRATE, SALT, DEHYDRATED ONION, MONOSODIUM GLUTAMATE, HYDROLYZED VEGETABLE PROTEIN (CORN, SOY, AND WHEAT), SPICE, DEHYDRATED GARLIC, CARAMEL COLOR, DISODIUM INOSINATE AND DISODIUM GUANYLATE, XANTHAN GUM, ARTIFICIAL FLAVOR, EXTRACTIVES OF PAPRIKA.

1,2-Quantitative Diacylglycerol (DAG) ELISA Kit

To be cleared via this
submission

12

S2MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as folle o

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

|1] Small Organs includes Breast, Thyroid and Testioles
|3] Musicial - Adult and Pediatria
|3] Museulas Skelut and Perilatina
|3] Museulas Skeletal - Neferial PW-CFM+PD
|7| C

2. Cardiac is Adult and Pediatric

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

[5] Compound Imaging (MView)

[6] 3D

[7] CMMI

[8] Elastosonography (Elax)

[8] Elastosonography (ElaXto)
[9] Includes contrast (CnT) in Adult Cardiac for left ventricle opacification
Visualization of the left ventricular endocardial border
[10] Inc

Ratio of Liver
(Contrast, Sharpness, etc.)

11] Virtual Navigator
12] Quantitative Elastosonography (QElaXto

2
1
0
9
8
7
6
5
4
3
2
1
0

Previously cleared via K1622

13

S5MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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

|| Small Organs includes Breast, Thyroid and Testioles
||| Small Organis And Prediatio
||| Marchino Skeletal - Netroir Listing
||| Muscillo Skeletal - NefiBellyPW-CFM+PD
|| C

[2] Cardiac is Adult and Pediatric.

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

[5] Compound Imaging (Mireview)

[6] 3D
[7] Char

[7]
CMM

[8] Elastosonography (Elast

[8] Ellastosonography (ElaXto)
[9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification
visualization of the left ventricular endocardial border
[10] I

INGREDIENTS: ENRICHED FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), VEGETABLE OIL (CONTAINS ONE OR MORE OF: CANOLA, COTTONSEED, PALM) WITH TBHQ (PRESERVATIVE), SALT, CONTAINS LESS THAN 2% OF: DEHYDRATED VEGETABLES (GARLIC, ONION, PARSLEY), MONOSODIUM GLUTAMATE, HYDROLYZED VEGETABLE PROTEIN (CORN, SOY, WHEAT), SUGAR, SPICES, MALTODEXTRIN, YEAST EXTRACT, DISODIUM INOSINATE, DISODIUM GUANYLATE, NATURAL FLAVOR, CARAMEL COLOR, SOY LECITHIN, POTASSIUM CARBONATE, SODIUM CARBONATE, SODIUM PHOSPHATE, TURMERIC (COLOR).

MAY CONTAIN: MILK, CRUSTACEANS, FISH.

Consideration of
Contrast Ratio
(HDR)

[11] Virtual Navigator
[12] Quantitative Elastosonography (QElaXto

3. DYNAMIC PROGRAMMING (CONTINUED)

Previously cleared via K1622

14

SB2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

	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
Portal	P	P	P		P	P	P		P	P: 5, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 8, 10
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7
Musculo-skeletal Superficial
Other (Urological, Gynecological)	P	P	P		P	P	P		P	P: 5, 7
SHFCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
							Mode of Operations
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color 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
Musculo-skeletal Superficial
Other (Urological)
I: New indication: P: Previously cleared by FDA: E: Added under Appendix
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: 5, 7, 11
Abdominal	P	P	P		P	P	P		P	P: 5, 7, 8, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 7, 11
Small Organs [1]										P: 5, 7, 11
Neonatal Cephalic	P	P	P		P	P	P		P
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5, 7, 11
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 7, 11
Musculo-skeletal Superficial
Other (Urological, Gynecological)	P	P	P		P	P	P		P	P: 5, 7, 11
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
Transvascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological, Gynecological)	P	P	P		P	P	P		P	P: 5, 7, 8, 11
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
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5, 7, 8, 11

inder Appe E: cleared by FDA; on; P: Previously N

11 Stanle Creatin Microsoft Photos and Particial Provinces
1978 - 1992 - 1992 - 1992 - 1992 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1996 - 1996 - 19

MICRO SPRAYER - PRESSURE REGULATING DISC
FULL, INV, ARY, RD

All Combined modes are: B+M+P+CH+N
FC (Combined modes), AR (mm/min)

1. Combined Parallel Imaging and Compressed Sensing for Fast 3D Cardiac Cine MRI with Improved Image Quality

[5] Compound images [6] 3D

[6] 3D
[7] CMM

[7] CMM
[8] Flastosong

[8]
Elastosonography (Elaxto)
[9]
Includes contrast (CnTI) in Adult Car

endocranial border
(ventricular surface) of the lateral wall of the caudal portion of the middle cranial fossa. Visualization of the lateral wall of the caudal portion of the middle cranial fossa is

Dual-purpose tonic lotion,
suitable for both
normal and combination
skin types.

ERS WINTER CLASSIC

[12] Quantitative Elastosonography (Q-Elastosonography)

Previously cleared via K161359

Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (Olf

15

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

[1] Small Organs includes Breast, Thyroid and Testioles
[2] Cardiac is Adult and Pediattic
[3] Cardiac is Adult and Pediatric
[4] Combined modes are: IB+M4PWK+CFM+PD
[5] Comp

[2] Cardiac is Adult and Pediatric.

CERVICAL EREctor Spinae Plane - NERVE BLOCK

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

[5] Compound Imaging (M-View)

[6] 3D
[7] CMM

CM
[
4

Elastosonography

[8] Elastosonography
[9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification a
visualization of the left ventricular endocardial border

Visualization of the left ventricular endocardial border.

[Tor.Cm]

111. Virtual Navigator

[10] CnTI
[11] Virtual Navigator
[12] Quantitative Elastosonography (QElaXto

Previously cleared via K16229

saote 6440 Ultrasound System 51

16

SI2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Company: DRY January, Inc.

SONS, DAUGHTERS, BROTHERS, SISTERS, FRIENDS, AND ASSOCIATES
Test Articles

[2] Cardiac Risk and Foundation

[3]
[4] Combined modoro: R+M+RW+CW+CEM+BI

[15] Compound Imaging (MVI) or ADP/AP

[6] 3D/4D
[7] CM

[7] CMM

Elastosonography (ElaxTo)

11 Reall Press Linds Linese Brand Provides
13 September 2017 - 17 PM ISS Lawser 2017
15 - 2010 - 12:55 PM 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 - 1 - 1

Arboretum and Visualization of the net

Concentration of Liver Extract in Charcoal-Stripped Fetal Bovine Serum (u/ml)

[[1] Virtual Navigator

112. Quantitative Elastography of Lax

reviously cleared via K16308

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(3) Musculo Skeletal - Nerve Block

4. Combined modes are: B; B+M; B+W; CH

ESC Compound Image Nview
Combine multiple images into a single image.

C[6]3D

[6] SD
[71] CIMM

[8] Elastosonography.

[9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification

NATIONAL BOARD FOR
PROFESSIONAL TEACHING STANDARDS

NON-COMMERCIAL REPRODUCTION PERMITTED
(II) This chapter is extracted from "Introduction to Characterization of
Composite Materials", edited by Hatem S. Hilal, published by DEStech
Publications, Inc.

Natural Perspect

[12] Quantitative Elastosonography

Previously cleared via K162290

Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (Olf

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'LC 3-13 Linear
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

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

LU Small Organs Breast, Thyroid, Fat and Particle

[2] Cardiac is Adult and Pediat

[3] Musculo Skeletal - Nerve Block

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

IEC Compound Imaging: An Overview

[6|3D]

[12] ICM
[5] pro

[7] CMM
[8] Elastosonography

[8] Elastos
[9]
ography (Lla
Includes contrast (CnT) in Adult Cardiac for left

11.2.2. Vector

TD2 Quantimetre FI. Elastosonography (QDElaxTO)

Previously cleared via K162290

Prescription Use Only Per 21 CFR 801 Part D Concurrence
CDRH, Office of In Vitro Diagnostics and Radiological Health (

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510(k) Submission Model 6440 Esaote S.p.A.

Traditional 510(k) Summary

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

807.92(a)(1)

Submitter Information

Esaote S.p.A. Via Enrico Melen 77 16152 Genova Italy

Contact Person:

Allison Scott, Associate Director 317.272.5419 Office 317.217.5361 Fax [e-mail]

Date:

October 13, 2017

807.92(a)(2)

Device

Common Name:	Ultrasound Imaging System
Trade Name:	6440 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System
Ultrasound Pulse Echo Imaging System
Transducer, Ultrasonic, Diagnostic	892.1550
892.1560
892.1570
Classification Number:	90IYN, 90IYO, 90ITX

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807.92(a)(3)

Predicate	510(k)	Device	Owner
Primary	K163082	6200 – MyLabEight eXP	Esaote S.p.A.
Primary	K163082	Virtual Navigator
Software	Esaote S.p.A.
Reference	K161359	6400 - MyLabSeven	Esaote S.p.A.
Reference	K150122	TomTec-Arena AutoLV	Tomtec Imaging Systems
GMBH
Reference	K163077	LOGIQ E9 with XDclear	GE Healthcare

Predicate Device(s)

This predicate has not been subject to a design-related recall

807.92(a)(4)

Device Description

Model 6440 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).

Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Model 6440 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6440 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

Model 6440 can drive Phased Array (PA), Convex Array (LA), Doppler and Volumetric probes.

Model 6440 is equipped with an internal Hard Disk Drive and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The marketing name for Model 6440 will be called MyLab9 eXP.

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510(k) Submission Model 6440 Esaote S.p.A.

807.92(a)(5)

Intended Use

Esaote's Model 6440 is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The 6440 system 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 Virtual Navigator software option for Esaote model 6440 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US, and PET). The second modality provides additional security in assessing the morphology of the real time ultrasound image. Virtual Navigator can be used in the following applications: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall, therefore, always be seen as an additional source of information.

The Virtual Navigator tracking system is contraindicated for patients, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

807.92(a)(6)

Comparison of Technological Characteristics

Model 6440 employs the same fundamental technological characteristics as the predicate devices.

Model 6440 is substantially equivalent to Esaote Model 6200 including the Virtual Navigator software option cleared via K163082, and Esaote Model 6400 cleared via K161359

New features for the 6440 include:

Auto Ejection Function (Auto EF) feature of Model 6440 is equivalent to TomTec-Arena already cleared by FDA with K150122

QPack Function feature of Model 6440 is equivalent to LOGIQ E9 with XDclear already cleared by K163077

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At a high level, the subject and predicate devices are based on the following same technological elements:

• Clinical uses for which Esaote Model 6440 is designed are equivalent to those of the Esaote Model 6200, already cleared via K163082.
• Models 6440, 6400, and 6200 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
• Transducers for use with the Esaote Model 6440 include transducers that are also available with the Esaote Model 6200, already cleared via K163082.
• · Models 6440, 6400, and 6200 ultrasound models provide similar measurements and analysis packages, with equal accuracy and precision.
• Models 6440, 6400, and 6200 ultrasound models have digital storage capabilities, including network connectivity.
• Model 6440 imaging modes are available on other FDA cleared ultrasound systems, for instance Esaote 6400 and 6200 ultrasound models
• The Model 6440 Auto EF (Auto Ejection Fraction) feature is equivalent to TomTec- Arena function AutoLV, already cleared via K150122.
• The Model 6440 QPack feature is equivalent to LOGIQ E9 with XDclear, already cleared via K163077.

The following technological differences exist between the subject and predicate devices:

• The Model 6400 and 6200 ultrasound systems do not have Auto EF or QPack features
• The Virtual Navigator feature is not available on the TomTec or LOGIQ E9 reference devices

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807.92(b)(1)

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the transducers associated with the Model 6440 ultrasound system was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

• · Cytotoxicity
• · Sensitization
• · Irritation

The ultrasound transducers are considered tissue contacting for a duration of less than 24 hours.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the Model 6440 ultrasound system. The system complies with the IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Mechanical and Acoustic Testing

Acoustic output testing was conducted according to NEMA Standards Publication UD 2-2004 Revision 3 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA Standards Publication UD 3-2004 Revision 2 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

807.92(b)(3)

Conclusions

The non-clinical data support the safety of the device and software verification and validation demonstrate that the Esaote Model 6440 ultrasound system should perform as intended in the specified use conditions.