6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

• K Number: K161359
• Device Name: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
• Manufacturer: Esaote S.p.A
• Date Cleared: 2016-07-19 ( 64 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Models 7400 and 7410 are 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, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto). All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery. Both models 6400 and 7400 are already cleared via K142008. Model 7410 is already cleared via K142077. Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below: - 1. Management of Intraoperative (Abdominal) application on 7410 Upgrade. - 2. Management of Laparoscopic application on both 7400 and 7410 Upgrades. - 3. Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade. - 4. Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades. - 5. Implementation of the QAS feature on 6400 and 7400 Upgrades. - 6. Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades. - 7. Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades. The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system.

Predicate Devices

K142008, K142077

Reference Devices

K110688, K061961, K101605, K113156

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and features, and does not mention AI or ML. The new features listed are related to application management and image enhancement techniques like "Needle Visibility," which are typically based on traditional image processing, not AI/ML.

Therapeutic

No
Explanation: The intended use states that the devices are for "diagnostic general ultrasound studies" and "provides imaging for guidance of biopsy and imaging to assist in the placement of needles," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are used to perform "diagnostic general ultrasound studies." Additionally, the product names in the "Predicate Device(s)" section, such as "MyLabSeven," "MyLabAlpha," and "MyLabGamma," support the diagnostic nature of these ultrasound systems.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are "mainframe ultrasound system" and "compact ultrasound system" equipped with physical components like wheels, handles, LCD color displays, control panels, and probes. These are hardware components, not solely software. The upgrades mentioned are enhancements to the existing hardware systems.

IVD (In Vitro Diagnostic)

Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
• Device Function: The descriptions clearly state that these are ultrasound systems used for diagnostic general ultrasound studies. They produce images of internal structures of the body using sound waves.
• Lack of Sample Analysis: There is no mention of these devices analyzing biological samples taken from the patient. Their function is based on real-time imaging of the body.

Therefore, these devices fall under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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

IYN, IYO, ITX

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Models 7400 and 7410 are 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, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto).

All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery.

Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below:

• 1. Management of Intraoperative (Abdominal) application on 7410 Upgrade.
• 2. Management of Laparoscopic application on both 7400 and 7410 Upgrades.
• 3. Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade.
• 4. Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades.
• 5. Implementation of the QAS feature on 6400 and 7400 Upgrades.
• 6. Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades.
• 7. Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades.

The 6400, 7400 and 7410 Upgrades are 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

Ultrasound

Anatomical Site

Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs (Breast, Thyroid, Testicles, Prostate), Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic, Urologic, Ophthalmic, Intraoperative Neurological, Transesophageal (Non Cardiac), Transurethral, Intravascular.

Indicated Patient Age Range

Adult and Pediatric

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.
The 6400, 7400 and 7410 Upgrades have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards:

• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• 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

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.

K142008, K142077

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.

K110688, K061961, K101605, K113156

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

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, resembling a family or group of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2016

Esaote S.p.A % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K161359

Trade/Device Name: 6400 Ultrasound System, 7400 Ultrasound System, 7410 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 12, 2016 Received: May 16, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

6400 Ultrasound System, 7400 Ultrasound System, 7410 Ultrasound System

Indications for Use (Describe)

Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other. Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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		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
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5
Cardiac [2]	P	P	P	P	P	P	P	P	P (7)	P: 5
Transesophageal (Cardiac) [2]	P	P	P	P	P	P	P		P	P: 5
Transesophageal (Non Cardiac)
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletal Conventional	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 N: 6

Diagnostic ultrasound imaging or fluid flow analysis of human body as 6400
Internation

Apper by F ed usly P: Previo

US Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

EC Confidence, inches arc D, in CH cord
EC Computed, inches arc D, in CH cord

6] 3D/4D

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

viously cleared via K142008 and to be cleared with this submissio

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

5

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	P: 5, 6
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6
Abdominal	P	P	P	P	P	P	P	P	P	P: 5
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P	P: 5
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P: 5
Pediatric	P	P	P	P	P	P	P	P	P	P: 5
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P: 5
Adult Cephalic	P	P	P	P	P	P	P	P	P	P: 5
Cardiac [2]	P	P	P	P	P	P	P	P	P (7)	P: 5
Transesophageal (Cardiac) [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6
Transrectal	P	P	P	P	P	P	P	P	P	P: 5, 6
Transvaginal	P	P	P	P	P	P	P	P	P	P: 5
Transurethral	P	P	N	N	N	N	N	N	P	N: 5
Intravascular	P	P	P	P	P	P	P	P	P	P: 5
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5
Laparoscopic	P	P	P	P	P	P	P	P	P	P: 5
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5 N: 6

id flow 7400
Interede

S

LLC Standard Options Includes Brass Drain, Overflow and Fasteners

2. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[ I ] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Museulo Skeletal - Ne Brediatric
[4] Museulo Skeletal - Net-DW+CW+CW+CW+CFM+P

IEC Combined Modes are: B, B/R, B/P, B/R/P, C/R, C/P, C/R/P. All new Compound Imaging Modes are:

Multiplanar (MPR) and Summed Compound Imaging (MV-Flow) 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of t

r production of the open in the ventricle opacification and visualization of the left ventricular endocardial border

reviously cleared via K142008 and to be cleared with this submission

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

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7 4 1 0
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|--------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5, 6 |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5, 6 |
| Abdominal | P | P | P | P | P | P | P | P | P | N: 5 |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 |
| Small Organs [1] | P | P | P | P | P | P | P | P | P | P: 5 |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P: 5 |
| Adult Cephalic | P | 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) | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P: 5 N: 6 |
| Transvaginal | P | P | P | P | P | P | P | P | P | P: 5 N: 6 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | N | N | N | N | N | N | N | N | N: 5 |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N: 5 |
| Musculo-skeletal Conventional
[3] | P | P | P | P | P | P | P | P | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 |
| Other (Urological) | P | P | P | P | P | P | P | P | P | P: 5 N: 6 |

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

J. SCHUMANN, MORRIS BAKER, M. THOMAS, AND ASSOCIATES
STRUCTURAL ENGINEERS

2. Cardiac is Adult and Pediatric

[3] Musculo skeletal - Nerve Block

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

E. Compound bearing maximum moment
F. Compound bearing minimum moment

[6] 3D/4D
Sunburst Imaging

[10] 5D/TP
[12] Includes control

] | Small Creats mobile & Break, Thynia and reacles
| | Master Seesel L. Personal Production | President Production of the loft ventional on the loft ventricular enclocation

Previously cleared via K142077 and to be cleare
with this submission

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

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	Model
Probe	6400 (96ch)
MyLabSeven
K142008	7400 (96ch)
MyLabAlpha
K142008	7410 (64 ch)
MyLabGamma
K142077	New
SP2430	1	1
SP2442	1	1
SP2730			1
AL2442	1	1	1
AL2443	1	1	1
SL1543	1	1	1
SL2325	1	1	1
SL3116	1	1	1
SL3235			1
SL3323			1
SL3332			1
AC2541	1	1	1
SC3123	1	1	1
SC3421			1
SI2C41	1	1	1	1
SE3123	1	1	1
SE3133	1	1	1	1
IOT342	1	1
IH 6-18	1	1	1	1
IL 4-13	1	1	1	1
LP 4-13	1	1	1	1
TLC 3-13	1	1	1	1
S2MCW	1	1	1
S5MCW	1	1	1
SHFCW	1	1	1
S2MPW	1	1
ST2613	1	1
ST2612	1	1	1
SB2C41	1	1	1
SB3123	1	1	1
LA435	1
LA523	1
CA430	1
EC1123	1	1
LP323	1
TRT33	1
IOT332	1
IOE323	1
BC431	1
BC441	1
BE1123	1

8

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

SP2430 (6400 and 7400 systems)

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

LL Southern Herbaria: Origins, Purposes, and People
N. Purposes: Breast, Thyroid, and Prostate

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatrio
[3] Musculo Skeletal - Ireliatrio
[4] Musculo Skeletal - IPE M+PW+CW+CFM+PD
[5] Co

15 Compound Imaging (Miview)

[6] 3D/4D compound (C6H10)

for a contrast (Crim) in Adult Cardiac for left ventricle opacification of the left ventricular endocardia
(Forder

Previously cleared via K142008

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

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

9

2442 (6400 and 7400 systems)

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

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

LL Small Organs includes Breast, Thyroid and Testicular

[2] Cardiac is Adult and Pediatric

[3] Musculo skeletal - Nerve Block

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

FCC Compliance Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
FCC ID: 2A4M7-NVR-D1

Compound Imaging (Multi-angle N13D/4D)

(1) I Panal Organis include Breat.
(2) Marian Security Produced Production of the March Production of the left ventricular endocation of the left ventricular endocation of t

eviously cleared via K14200

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

10

P2730 (7410 system)
ended 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

SPRING MONTHS BRING: Allergies, Asthma, Bronchitis, Colds, Coughs, Flu, Pneumonia, Sinus Infections

2. Carrots, Fruit and Peanuts

2. Cardiac is lean and I can run
3. Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging (Mreview).

6[b]/3D/4D

11 Small Organ includes Breat, Thyrold and Treates
11 Station Search Press 1970, 1992 - 1992, 1992, 1992, 1992, 1992, 1992, 1994, 1994, 1994, 1994, 1994, 1994, 1994, 1994, 1

Previously cleared via K1420

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

11

AL2442 (6400, 7400 and 7410 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of

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

[ I ] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Cardiac is Adult and Pediatric
[4] Musculo Skeletal - Netal-PW+CFM+PD
[5] Com

[2] Cardiac is Adult and Pediatric

3. Musculo Skeletal - Nerve Block

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

5 Compound Imaging (M-View)

3D/4D

f in the local of the open in the ventricle opacification and visualization of the left ventricular endocardial border

reviously cleared via K14207

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

12

AL2443 (6400 and 7400 systems)

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

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

indication; P: Previously cleared by FDA; E:Added under Appendix 1

UI: Somatic Organs includes Breast, Thyroid and etc.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Museulo Skeletal - Invelocio
[3] Museulo Skeletal - Intel PW+CFM+PD
[5] Compound

[5] Compound Imaging
[6] 3D/4D

(F) 3D/4D
(7) Includes contrast (CrTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardia
border

Previously cleared via K14200a

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

13

.1543 (6400, 7400 and 7410 systems)

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

ನಿ i;

All Organs includes Breast, Thyroid and Testicles.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

$\mathbb{R}^{3D/4D}$

II I Small Organ Include Ireation
12 Marchies Status Art Programment Provinces of Archives of the left ventreals of the left ventricular endocardial bard

eviously cleared via K1420'

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

14

.2325 (6400, 7400 and 7410 systems)

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

ನಿ i;

U.S. Small Business Administration
Office of Disaster Recovery and Resilience

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

CK
[4] Combined modes are: B+M+PW+CEM+F

5.1 Combined Indices (Macro: MRPEW)

Multiplanar (MPR) Compound Imaging (MVI) 2D/3D/4D

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

I I I Small Organ Include Ireation
I II Statulo Status Architect
I (2) Statulo Station Programment Producer
In Combine Archive Provential PD
In Componition of Provention on

eviously cleared via K1420'

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

15

L3116 (6400, 7400 and 7410 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

2.2.2.1. Dynamic and Static
Cartographic Generalization

2. Cardiac (Voluntary) - Peristaltic
3. Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

6[3D/4D

6[3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

Previously cleared via K13390

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

16

L3235 (7410 system)
ended 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

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - IPE: IPW+CFM+PD
[5] Com

2023 Senior Faculty and Pediatric
Service is Honored at Pediatric
Grand Rounds

3] Musculo Skeletal - Nerve Blood
4] Cardiac is Involuntary and Found in Heart

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

[5] Compound Imaging (M-view)

16[6]/3D/4D

p|3D/4D.

(6) 5D/4D
(7) Includes contrast (CrTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardi
border

Previously cleared via K1420

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

00, 7400, and 7410 Upgrades 510(

Esaote S.p.A

17

L3323 (7410 system)
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Yokof Coun

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

2. Services include Adult and Pediatric
   Cardiac Anesthesia and Perfusion.

3] Musculo Skeletal - Nerve Blood
4] Cardiac is Involuntary and Found in Heart

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

[5] Compound Imaging (MView)

[6|3D/4D

17. Includes contrast

(6) 5D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

Previously cleared via K1420

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

18

L3332 (7410 system)
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human baYaka Sove

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

Service is Active and Performing
2. Service is Active and Performing

3] Musculo Skeletal - Nerve Blood
4] Cardiac is Involuntary and Found in

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

[5] Compound Imaging (MView)

[6|3D/4D

17. Includes contrast

(6) 5D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

Previously cleared via K1420

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

19

AC2541 (6400, 7400 and 7410 systems)

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

C

Small Orchard Street, Brest, Ireland and the world beyond.

[2] Cardiac is Adult and Pediatric

(3) Musculo Skeletal - Nerve Block

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

E 5 Compound Imaging (M-view)
F 6 Combined modes (B+M or P+M or C+M)

[6]3D/4D

| | | Brand Drawa included Breast, Thropia and Traticle
| | | Masting Adault of Production | Production | |

Previously cleared via K14207

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

20

3123 (6400, 7400 and 7410 systems)

hded use: Diagnostic ultrasound imaging or fluid flow analysis s

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

All Organs includes Breast, Thyroid and Testicles.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound imaging (M-view)

S13D/4D
[Compound and Imaging]

(1) Small Organ Include Ireasch (Treasele
(2) Musical Calenda (1) Province (1) Province (1) Province (1) Produced (1) Produced (1) Produced on the left ventricular endocardi

eviously cleared via K14207

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

21

C3421 (7410 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

2023 Pediatric Cardiac Intensive Care Society

2] Cardiac is Adult and Round
3] Muscle Skeletal, Nerve Blood

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

[5] Compound Imaging (M-View)

[6] 3D/4D Compound mixture

6[3D/4D

(6) 5D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

Previously cleared via K1420

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

22

l2C41 (6400, 7400 and 7410 systems)
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

,

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - IPE: IPW+CFM+PD
[5] Com

2. Carries Adult and Pediatric

3. Cardiac is Adult and Pediatric

4. Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging (Mview)

6b/3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

to be cleared with th

To be cleared with this
submission

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

00, 7400, and 7410 Upgrades 510(

Esaote S.p.A

23

SE3123 (6400, 7400 and 7410 systems)

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

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

Clinical Small Organs includes Breast, Thyroid and parathyroid and ...

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (M-View)

[6] 3D/4D

|| Beaul Organis included Breast, There and Traticle
|| Manager Search - President - President - President - President - President - Presidential of the left ventricular end

Previously cleared via K14207

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

24

E3133 (6400, 7400 and 7410 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

. ﻣ

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatrio
Musculo Skeletal - Nes Brook
Combined modes ar: : D+D+DW+CFM+PD
Compound Imaging (Mview)

ি

1. Cardiac (Rigid and Fatigue Resistant)

12. Muscle Skeletal - Nerve Block

തുടെ ത

| 5 | Compound Imaging (M.View)

[6] 3D/4D

[7] Includes contrast (C-T1) in Adult Cardiac for left ventricle

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this submission

submission

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

25

OT342 (6400 and 7400 systems)

ntended use: Diagnostic ultrasound imaging or fluid flow analysis

Application: Diagnostic ultrasound imaging of human body.

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

TF Small Organs includes Breast, Thyroid and Testis.

[12] 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

III Small Organis necialed
J. Shamber Status Art Child Creating Comments of Child Child Child Child Child Child Child Child Child Child Child Christialian and visualization

eviously cleared via K14200

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

26

| 6-18 (6400 and 7400 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human - Maga of Co

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

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatric
Museulo Skeletal - Ne: Deck
Combined modes are: B+M4PW+CFM+PD
Compound Imaging (Mview)

[2] Cardiac is Adult and Pediatric.

13. Musculo Skeletal - Nerve Block

R.K. DU. 08/2023

1. Combined indices are: DMPWT*CH
2. Computed Images (Minimum)

[5] Compound Imaging (Mview)

[6]3D/4D

(3) Muadua Siedetal - Nerve Block
(4) Combined moder are: M+PW+CFM+PD
(6) Somined Imaging (Mview)
(6) 2007/10
(6) 2007/100
Societ

To be cleared with this
submission

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

27

H 6-18 (7410 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Make f Sa

..

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - IPE: IPW+CFM+PD
[5] Com

SDC Standard & Dynamic
Microplate Barcoding

3. Muscle: Skeletal, Nerve, Blood
4. Cardiac, Renal, and Peadiatric

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

[5] Compound Imaging (MView)

[6]/3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this submission

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

00, 7400, and 7410 Upgrades 510(

Esaote S.p.A

28

. 4-13 (6400 and 7400 systems)
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

Dynamic
Programming

3. Muscle: Skeletal, Nerve, Blood
4. Cardiac is Heart and I connect

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

[5] Compound Imaging (MView)

16[6]/3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this
submission

submission

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

29

. 4-13 (7410 system)
cended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

the

[ I ] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Interestorio
[4] Musculo Skeletal - INFLFERFALAPW+CFM+PD
[5

2. Cardiac vs Adult and Pediatric

3. Cardiac is Auricular and I striated

4. Muscle Skeletal - Nerve Blood

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

[5] Compound Imaging (Mirror View)

[6]/3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with th

To be cleared with this
submission

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

00, 7400, and 7410 Upgrades 510(

Esaote S.p.A

30

P 4-13 (7400 and 7410 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[ I ] Small Organs includes Breast, Thyroid and Testicl
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Ireleville
[4] Musculo Skeletal - IP: IPM+PW+CFM+PD
[5] Comp

SCience is Dynamic
and tentative

11. Cardiac to Renal and Periadrenal
12. Musculo Skeletal - Nerve Block

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

| 5 | Compound Imaging (M.View)

[6] 3D/4D

6[3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this submission

submission

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

31

P 4-13 (6400 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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	E	E	E		E	E	E		E	E: 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	E	E	E		E	E	E		E	E: 5
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
- New indication; P: Previously cleared by FDA: E:Added under Appendix E

[ I ] Small Organs includes Breast, Thyroid and Testicl
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Ireleville
[4] Musculo Skeletal - IP: IPM+PW+CFM+PD
[5] Comp

2. SCr values in Adult and Pediatric patients

3] Musculo Skeletal : Nerve Blood
4] Cardiac is Auric and I cardiac

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

[5] Compound Imaging (MView)

f6|3D/4D

6/3D/4D

(6) 5D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this submission

submission

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

00, 7400, and 7410 Upgrades 510(

Esaote S.p.A

32

LC 3-13 (6400, 7400 and 7410 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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

ы

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatrio
Musculo Skeletal - Nes Brook
Combined modes ar: : D+D+DW+CFM+PD
Compound Imaging (Mview)

ি

1. Cardiac is Adult and Pediatric
2. Muscle Skeletal - Nerve Blood

തുടെ ത

| 5 | Compound Imaging (M.View)

I6I/3D/4D

(6) 3D/4D
(7) Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocard
border

To be cleared with this
submission

submission

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

00, 7400, and 7410 Upgrades 5100

Esaote S.p.A

33

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)

2MCW (6400, 7400 and 7410 systems)

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

der Appendix ion; P: Previously cleared by FDA;

[1] Small Organs Includes Breast, Thyroid and Prostate

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

EC Compound Imaging (M-view)

[5] Compound Imaging
[6] 3D/4D

|| Small Organa moludes Breast, Thyold and Traticles
|| Sharine Mault Prices | Physican Production | Province | Program | Program | Program | Programmar endocardia

Previously cleared via K14207

34

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
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 [3]
Other (Urological)

S5MCW (6400, 7400 and 7410 systems)

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

Appendix FDA; ion; P: Previously cleared by P

Small Organs Structures [1]:

• Thyroid and Parathyroid
• Breast
• Skin

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

13. Compound Imaging: Averaging multiple images of the same anatomy, acquired from different imaging angles, to produce a single image.

[E] Combined modes or B + M mode

[5] Compound matching
[6] 3D/4D

|| Small Organa indudes Breast, Thypia and Traileles
|| Annual Seater - President
|| Armine Seater - Presentation - President - Provincial - Provincial of the Information of

Previously cleared via K14207

35

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

SHFCW (6400, 7400 and 7410 systems)

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

der Appendix ion; P: Previously cleared by FDA;

11. Small Organs includes Breast, Prostate, Thyroid and Adrenal.

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

E Compound Imaging (M-View)

[6] 3D/4D

(1) Small Organization (1974)

Previously cleared via K14207

36

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
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)

MPW (6400 and 7400 system)

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

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

US Small-Cap Growth includes Small Growth, Mid-Cap Growth, and Micro-Cap Growth. The Russell 2000 Growth Index is used as a benchmark.

[2] Cardiac is Adult and Pediatric

[3/3] Musculo Skeletal - Nerve Block

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

1. Compact modes as A, B, C, D, E, F, W, CH, CPL
   15 Compound Imaging (M-view)

sum number [6] compound [6]/3D/4D

|| Band Logent moduces Break, Thyrold and President
|| Shipping Mault Production - Posted on President - President - Province President of the Left ventrialler endocarding

Previously cleared via K142008

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

37

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)	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)

613 (6400 and 7400 system)

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

1 oy i;

11 Small Organs including Brain, Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5 Compound Imaging (M-view)

$\sigma_{3D/4D}$

(1) I Panal Organis include Breat.
(2) Marian Security Produced Production of the March Production of the left ventricular endocation of the left ventricular endocation of t

eviously cleared via K14200

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

38

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: 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

ST2612 (6400, 7400 and 7410 systems)

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

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

US Similar Organs: Breast, Thyroid and Pituitary

2. Cardiac is Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Myview)

[6]3D/4D

|| Band Logana moludes Breat, Thyreia and Traticles
|| Anathia Search - Previous President
|| Cambine Search - Presentation - PD
|| Cambine Seather Prices Archive on entract

Previously cleared via K14207

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

39

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations							Tissue Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P		P	P: 5, 6
Abdominal										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)

SB2C41 (6400, 7400 and 7410 systems)

htended use: Diagnostic ultrasound imaging or fluid flow analysis of human

rbbi ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION ACT 1949
SECTION 39 (1) INSTRUMENT OF DELEGATION
I, MARK ALAN HUTCHINSON, Chief Executive of the Commonwealth Scientific and Industrial Research Organisation, by this instrument, under section 39(1) of the Science and Industry Research Organisation Act 1949, delegate to Dr Kirstin Ross, my powers and functions under section 26(1) of that Act.

This instrument takes effect on the date it is signed.

Dated: 10 October 2023

[Signed]
MARK ALAN HUTCHINSON
Chief Executive

12. Cardiac is Adult and Pediatric

3. Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MyView).

[6]3D/4D

[✓] Includes contrast (Cr,Tm) in Ad

I I J Band Drants includes Brease
I I Mastin e Mault e Marcel Province Articles
I Cambine Master a President of Production of the left ventricular and visualization of t

Previously cleared via K14207

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

40

33123 (6400 and 7400 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

bb ( At

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatric
Musculo Skeletal - News Blokk
Combined modes are: B+M+PW+CFM+PW+CFM+PD
Compound Imaging (Mri

12. Cardiac is Adult and Pediatric.

13. Musculo Skeletal - Nerve Block

4]
nea
les are: B+1
[5] Compound Imaging (Muiom)
CFM

[5] Compound Imaging (Miview)

[6]3D/4D

(3) Muaculo Siedel - Nerve Block
(4) Combined moder are: P.M.PW-CPM+PD
(6) Sombiner Mirien)
(6) 2007 (10) in Adult Cariac for left ventricle opacification and visualization o

Previously cleared via K142008 and v
this submission

41

SB3123 (7410 system)
htended 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] | Tissue Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|--------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| Ophthalmic | | E | | | | | | | | |
| Fetal | | E | E | | | E | | | E | E: 5, 6 |
| 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: 5 |
| Transvaginal | | E | E | | E | E | E | | E | E: 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
[3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | E | E | | E | E | E | | E | E: 5 N: 6 |

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

Somali Democratic Republic
Ministry of Mineral & Water Resources
Geological Survey Department
(Somalia's Crude Oil Potentialities)

2. Cardiac Arrest in Adult and Pediatric

[13] Musclo skeletal - Nerve Block

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

[5] Compound Imaging (Myview)

[6]3D/4D

includes con

I I Small Organiz Includes Dreats Christian President
I Museum e Mault Printer Province Province Province Province of the Internation of the Intellation of the Intellation

Previously cleared via K142008 and v
this submission

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

42

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 [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)

LA435 (6400 system)

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

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

111 South Orange Avenue, Newark, NJ 07103
"Thyroid and Parathyroid Specialists, Inc."

[2] 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] Small Organ include Dreats.
[1] Marial Break, 18 (4) 2014) 14:47 PM IST (1978) 1974) 1978 (1992) 1991) 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1991 1

eviously cleared via K14200

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

43

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
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
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	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)

LA523 (6400 system)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human ond in 1

pp A AT

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Cardiac is Adult and Pediatric
[3] Museulo Skeletal - IRF Delock PDFM+PD
[5] Com

2. Services include:

• Basic Services
• Standard Services
• Premium Services

31. Martin Strelci, R. Nova Rocka 16,
    9240 Ljutomer, Slovenija
    (strošek za tisk v reviji)

4. Combined modes are: B, B*, M, PW+B*, M+PW+C*.

15 Compound Imaging (Mrview)

6. 3D/4D

[6] 3D/4D
[7] Includes contrast (CrTI) in Adult Cardiac for left ventricle opacification of the left ventricular endocardi
border

eviously cleared via K14200

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

44

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	E	E	E		E	E	E		E	E: 5
Abdominal	E	E	E		E	E	E		E	E: 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	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)	E	E	E		E	E	E		E	E: 5

und imaging or fluid flow analysis of human hody CA430 (6400 system)

Intended use: Diagnostic ultraso

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

The Similar Organs Includes Breast, Thymus, and Bone Marrow. They are Involved in Food and Hormone Production.

2. Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

[3D/4D]

of the local of the extricle opacification and visualization of the left ventricular endocardial border.
If in

reviously cleared via K14200

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

45

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
Fetal	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: 5
Transvaginal		P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)		P	P		P	P	P		P	P: 5
1: New indication; P: Previously cleared by FDA; F:Added under Appendix F

1123 (6400 and 7400 systems)

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

оу ed : Prev

11 Small Oregon Inches Breast, Thyroid and Testicular

[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] Small Organ includes Break, Thyrold and Traticles
[1] Westler Arelett - Mercel Collection - Previous - Previous - Provinces - Presidential - Processor - Presidential Pr

eviously cleared via K1420

00, 7400, and 7410 Upgrades 5100

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

46

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: 5
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]

: . Is 4 :: LP323 (6400 system)

htended use: Diagnostic ultra

r (specify)

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

11. Small Oregon Stream Increases Breast, Hip, and Thigh Ratio

[2] Cardiac is Adult and Pediatric

(3) Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-View)

[6] 3D/4D

|| Band Dranz models Break, Thyoid and Peticies
|| Manine Mall Prices (1994) - 1994 - 1994 - 1994 - 1994 - 1994 - 1994 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 1991 - 199

Previously cleared via K14200a

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

47

「RT33 (6400 system)
htended 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] | 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: 5 |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | P | | | P | P | | P | P: 5 |

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

CT Scan Opens Brain, Breast, Prostate, Thyroid and Lung Cancer Research

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (N-view)

[6] 3D/4D
compounds

( I ) amel Presse, Involetter
I Manufa Mallano
I Manufa Sected

Previously cleared via K142008

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

48

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

IOT332 (6400 system)

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

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

The problem and the solution: Spanish Onion, Swiss Brown, Breast, Shiitake, Oyster, and Portobello mushrooms studied in [11].

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

5. Compound Imaging (M-view)

[6]3D/4D

[1] Small Organ Included Breast, Thropia and Trestoles
| | Maniel Seather - President
| | Samino Seather - President - President - President - Presidention and visualization

Previously cleared via K142008

49

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

OE323 (6400 system)

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

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

US. Organs includes Breast, Thyroid and Prostate.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

[6]3D/4D

(1) Small Organ includes Breach Provides
(1) Marchite Areality of Production (1) March (1) Marchite (1) Marchite (1) Manufaction of the Intribution of the left ventrioular

Previously cleared via K14200a

50

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

BC431 (6400 system)

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

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

[List of Small Organs includes Breast, Thyroid and Pituitary]

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-View)

[5] Compound Imaging
[6] 3D/4D

|| Senall Organ included Break, Thyota ma Treticle
|| Sension and Press and Press.
|| Campion Senation | Properto
|| Campion Seating | Property | Po
|| 2014-01-19 || Leader C

Previously cleared via K14200

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

51

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

BC441 (6400 system)

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

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

US Small Organs Screen includes Breast, Thyroid and Pelvis

[2] Cardiac Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

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

6. [5] Compound Imaging (N-view)

[6] 3D/4D
[c] Compound

|| Senall Organ included Break, Thyota ma Treticle
|| Sension and Press and Press.
|| Campion Senation | Properto
|| Campion Seating | Property | Po
|| 2014-01-19 || Leader C

Previously cleared via K14200a

52

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]
Ophthalmic	P	P
Fetal	P	P	P		P	P	P
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic

1123 (6400 system)

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

Other (specify

Harmonic
Imaging (TEI)

Tissue Velocity
Mapping (TVM)

ed

P: 5, 6

d

P: 5, 6
P: 6

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в d

d
d

d
d

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ﮨﮯ ﮨﮯ ﮨﮯ

P d

ransesophageal (Cardiac)
ransesophageal (Non Cardiac

ardiac [2]

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix

Musculo-skeletal Conventional

Peripheral Vascular

aparoscopic

Transrectal
Transvaginal
Transvaginal
Intravascuretinal
Intravascular

Musculo-skeletal Superficial [

Cellular Organs [1] - Includes Breast, Thyroid and Prostate

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M, B+PV, M+PV, C+M, C+PV

| Small Organs includes Breast, Thyroid and Testic
Cardiac is Adult and Pediatric
| Museulo Skeletal - New Documents
| Museulo Skeletal - NewsPW+CFM+PD
Compound Imaging (Mvie

[6]3D/4D

[5] Compound Imaging (Mview)
[6] 3D/4D
[7] Includes contrast (CrTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardi
bor

reviously cleared via K14200

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

53

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 A. Siffredi 58
16153 Genova
Italy
Contact Person:	Allison Scott, Managing Consultant
317.228.8719 Office
317.228.8701 Fax
[e-mail]
Date:	April 19, 2016
807.92(a)(2)
	Devices
Common Name:	Ultrasound Imaging System
Trade Name:	6400 Ultrasound System
7400 Ultrasound System
7410 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

54

Predicate	510(k)	Device	Owner
Primary	K142008	6400 – MyLabSeven
7400 – MyLabAlpha	Esaote S.p.A.
Primary	K142077	7410 – MyLabGamma	Esaote S.p.A.
Reference	K110688	7340 – MyLab30 Gold	Esaote S.p.A.
Reference	K061961	ART.LAB	Esaote Europe B.V.
Reference	K101605	8100 – MyLabOne	Esaote Europe B.V.
Reference	K113156	SonoSite Edge	Fujifilm SonoSite, Inc.

Predicate Device(s)

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

807.92(a)(4)

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Models 7400 and 7410 are 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, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Models 6400 and 7400 manages Qualitative Elastosonography (ElaXto).

All models 6400, 7400 and 7410 are equipped with a LCD color display where acquired images and advanced image features are shown. All models 6400, 7400 and 7410 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes). Model 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

Models 7400 and 7410 the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. All models 6400, 7400 and 7410 are equipped with wireless capability. Models 7400 and 7410 have been designed to be powered by battery.

Both models 6400 and 7400 are already cleared via K142008. Model 7410 is already cleared via K142077.

55

Models 6400, 7400 and 7410 Upgrades, defined herein, combine the cleared features of both 6400, 7400 and 7410 systems with new capabilities, listed below:

• 1. Management of Intraoperative (Abdominal) application on 7410 Upgrade.
• 2. Management of Laparoscopic application on both 7400 and 7410 Upgrades.
• 3. Addition of Transrectal/Urology and Transvaginal applications in 3D/4D on 7410 Upgrade.
• 4. Addition of Urology application in 3D/4D on both 6400 and 7400 Upgrades.
• 5. Implementation of the QAS feature on 6400 and 7400 Upgrades.
• 6. Implementation of the Needle Visibility feature on all 6400, 7400 and 7410 Upgrades.
• 7. Implementation of the on-board tutorial MyLibrary feature on all 6400, 7400 and 7410 Upgrades.

The 6400, 7400 and 7410 Upgrades are manufactured under an ISO 9001 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 6400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7400 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7410 provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

56

807.92(a)(6)

Technological Characteristics

The 6400, 7400 and 7410 Upgrades employs the same fundamental technological characteristics as their predicate devices.

The 6400 Upgrade model is substantially equivalent to Esaote 7340 model cleared via K110688, Esaote Europe's 8100 already cleared via K101605, Esaote Europe's ART.LAB already cleared via K061961, SonoSite Edge already cleared via K113156 and to Esaote 6400 model cleared by FDA via K142008.

The 7400 Upgrade model is substantially equivalent to Esaote 7340 model cleared via K110688, Esaote Europe's 8100 already cleared via K101605, Esaote Europe's ART.LAB already cleared via K061961, SonoSite Edge already cleared via K113156 and to Esaote 7400 model cleared by FDA via K142008.

The 7410 Upgrade model is substantially equivalent to Esaote 7340 model cleared via K110688, Esaote Europe's 8100 already cleared via K101605, SonoSite Edge already cleared via K113156, 7400 model cleared by FDA via K142008 and to Esaote 7410 model cleared by FDA via 142077.

• Clinical uses for which Esaote 6400, 7400 and 7410 models have been respectively cleared by FDA via K142008 and K142077 are not changed by 6400, 7400 and 7410 Upgrades, to be cleared via this submission.
• Clinical uses for which Esaote 6400 and 7400 Upgrades are designed are equivalent to those of 7340 model, cleared via K110688.
• Clinical uses for which Esaote 7410 Upgrade is designed are equivalent to those of Esaote 7340 model, cleared via K110688 and those of Esaote 7400 models, cleared by FDA via K142008.
• 7410 Upgrade for Intraoperative (Abdominal) application is equivalent to those of Esaote 7400 model, cleared via K142008.
• 7400 and 7410 Upgrades for managing Laparoscopic application are equivalent to those of Esaote 6400 model, cleared via K142008.
• · 7410 Upgrade for managing Transrectal/Urology and Transvaginal applications in 3D/4D is equivalent to those of Esaote 7340 model, cleared via K110688.
• . 6400 and 7400 Upgrade for managing Urology application in 3D/4D is equivalent to those of Esaote 7340 model, cleared via K110688.
• · 6400, 7400 and 7410 Upgrades including the Needle Visibility feature is equivalent to those of SonoSite Edge, already cleared via K113156.
• . 6400, 7400 and 7410 Upgrade including the on-board tutorial MyLibrary feature, that provide application aid and tips in the use of the system during procedures is equivalent to those of model 8100, already cleared via K101605.
• 6400 and 7400 Upgrades including the QAS feature is equivalent to those of ART.LAB software, already cleared via K061961.
• Esaote's 6400 Upgrade, 7400 Upgrade, 7410 Upgrade, 6400, 7400, 7410, 7340, 8100 and SonoSite Edge are designed to meet the IEC 60601-2-37 safety requirements.
• Esaote 6400 Upgrade, 7400 Upgrade, 7410 Upgrade, 6400, 7400, 7340, 8100 and SonoSite Edge ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

57

807.92(b)(1)

Summary of Non-Clinical Tests

The 6400, 7400 and 7410 Upgrades have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-37
• 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 6400, 7400 and 7410 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.