Esaote's Model 6200 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), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6200 system 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 6250 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), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The 6250 system 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.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only.

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

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

Device Description

Both 6200 and 6250 upgrades are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 models are equipped with a LCD color display where acquired images and advanced image features are shown.

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

Both 6200 and 6250 models including the Virtual Navigator software option have been cleared via 510(k) 153277.

Both 6200 and 6250 upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with new capabilities, listed below:

. Implementation of the MyLabRemote feature on both 6200 and 6250 upgrades
। Addition of in Elastosonography (ElaXto) analysis in Intraoperative (Neurological) application on both 6200 and 6250 upgrades
-Management of Quantitative Elastosonographic analysis (QElaXto) in Abdominal application on 6200 upgrade
-Implementation of the Automatic Nuchal Translucency feature on both 6200 and 6250 upgrades
-Addition of new probes on both 6200 and 6250 upgrades

Furthermore, the Virtual Navigator upgrade, defined herein, combine the cleared features of the Virtual Navigator with new software capabilities compatible to both 6200 and 6250 upgrades related to the Virtual Navigator software option and listed below:

Availability in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
-Availability of Elastosonography (ElaXto) analysis in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
-Availability of Quantitative Elastosonographic analysis (QElaXto) for Abdominal application in the Virtual Navigator upgrade environment
-Navigation software new user interface on Virtual Navigator upgrade

The marketing names for 6200 and 6250 upgrades will be called MyLabEight respectively.

The different versions of 6200 and 6250 models and their upgrades are differentiated by part numbers.

Both 6200 and 6250 upgraded models are manufactured under an ISO 9001 and ISO 13485 certified quality system.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from Esaote S.p.A. to the FDA for their 6200 Ultrasound System and 6250 Ultrasound System. This document outlines the general intended uses and provides some technical specifications and conformity to safety standards. It does not contain information about the acceptance criteria for a specific AI-powered device, nor does it detail a study proving such a device meets those criteria, as there is no mention of an AI-powered device beyond the "Virtual Navigator" which is described as supporting, not replacing, human radiological review.

The document states: "The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information."

This description indicates that the Virtual Navigator is an image fusion tool for enhanced visualization, not an AI diagnostic system with specific numerical performance metrics. Therefore, the requested information (acceptance criteria, specific study results, sample sizes, expert involvement, and ground truth for AI performance) is not present in this document.

The document focuses on demonstrating substantial equivalence of the ultrasound systems and the Virtual Navigator software option (which appears to be an image fusion tool, not an AI with diagnostic capabilities as typically understood in the context of acceptance criteria measured by metrics like AUC, sensitivity, specificity, etc.) to previously cleared predicate devices. The "Summary of Clinical Tests" explicitly states: "No clinical tests were performed."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study proving an AI device meets them using only the provided text. The document is primarily a regulatory filing for a medical imaging device and its software features, demonstrating safety and performance equivalence, not a detailed report on the validation of an AI diagnostic algorithm against predefined performance metrics.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features 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, stacked on top of each other.

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

March 16, 2017

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

Re: K163082

Trade/Device Name: 6200 Ultrasound System and 6250 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: February 13, 2017 Received: February 14, 2017

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Indications for Use

510(k) Number (if known)

K163082

Device Name

6200 Ultrasound System and 6250 Ultrasound System

Indications for Use (Describe)

Esaote's Model 6200 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, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

Esaote's Model 6250 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, Transrectal, Pediatric, Intraoperative (Abdominal), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutanes or surgical operations providing additional image information from a second imaging modality (CT, MR, US, PET and others). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculos, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), Peripheral Vascular and Transcranial for radiological examinations only. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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6200
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Fetal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 10, 11 N: 12
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8 N: 11
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5, 6, 7 N: 8, 11
Intraoperative Neurological	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Pediatric	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7
Adult Cephalic	P	P	P	P	P	P	P	P	P(9)	P: 5, 6, 7
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P		P	P: 5, 6, 7
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Transurethral	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Intravascular	P	P	P	P	P	P	P		P	P: 5, 6, 7
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Laparoscopic	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 10, 11
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8 N: 11
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P: 5, 6, 7 N: 8, 11
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Adult Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Cardiac [2]	P	P	P	P	P	P	P	P	P(9)	P: 5, 6, 7
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transrectal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Transvaginal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Transurethral	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intravascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Laparoscopic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P
Fetal	P	P	P		P	P	P			P: 5, 6, 7
Abdominal	P	P	P		P	P	P			P: 5, 6, 7
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricSmall Organs [1]	P	P	P		P	P	P			P: 5, 6, 7
Neonatal Cephalic	P	P	P		P	P	P			P: 5, 6, 7
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5, 6, 7
Transesophageal (Cardiac)Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7
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	P: 5, 6, 7
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 10
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
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, 7, 11
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 10, 11
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Other (Urological)	P	P	P		P	P	P		P	P: 5, 6, 7
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 10, 11
Abdominal	P	P	P	P	P	P	P	P	P
Intraoperative (Abdominal)							P
Intraoperative Neurological							P
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Neonatal Cephalic							P
Adult Cephalic							P
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
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	P	P: 5, 6, 7, 11
Laparoscopic							P
Musculo-skeletal Conventional [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological	P	P	P	P	P	P	P		P	P: 5, 6, 7 N: 11
Pediatric	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P (9)	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
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]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P			P: 5, 6, 7, 11
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7, 11 E: 8
Abdominal	P	P	P		P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Other (Urological)	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
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
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological	P	P	P		P	P	P		P	P: 5, 6, 7 N: 8, 11
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Transvascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Other (Urological)	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Adult Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Transrectal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Transvaginal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Transurethral	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intravascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Laparoscopic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
N: New indication; P: Previously cleared by FDA; E: Added under Appendix E
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7, 10
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 8
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7
Other (Urological)	P		P		P	P	P		P	P: 5, 6, 7
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
Fetal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 10, 11
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Intraoperative Neurological	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Pediatric	P	P	P	P	P	P	P		P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Cardiac [2]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Transesophageal (Cardiac)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Transurethral	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Intravascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Laparoscopic	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8, 11
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P			P: 5, 6, 7, 11
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7, 10, 11
Intraoperative (Abdominal)									P
Intraoperative Neurological									P
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Other (Urological)	P		P		P	P	P		P	P: 5, 6, 7, 11
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)					P	P	P
Intraoperative Neurological			P		P	P	P		P	P: 5, 6, 7
Pediatric
Small Organs [1]		P	P		P	P	P		P	P: 5, 6, 7
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]		P	P		P	P	P		P	P: 5, 6, 7
Musculo-skeletal Superficial [3]		P	P		P	P	P		P	P: 5, 6, 7
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
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P		P	P	P	P	P		P	P: 5, 6, 7
Small Organs [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P		P	P	P				P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional
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
Abdominal	P	P	P	P	P	P	P			P: 5, 6, 7, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P			P: 5, 6, 7, 11
Small Organs [1]
Neonatal Cephalic	P	P	P	P	P	P	P			P: 5, 6, 7
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P		P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color 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	P: 5, 6, 7
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 10
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5, 6, 7
Cardiac [2]	P	P	P	P	P	P	P	P	P (9)	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional
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: 5, 6, 7, 11
Fetal	P	P	P	P	P	P	P			P: 5, 6, 7, 10, 11
Abdominal	P	P	P	P	P	P	P			P: 5, 6, 7 N: 11
Intraoperative (Abdominal)									P	P: 5, 6, 7, 11
Intraoperative Neurological									P	P: 5, 6, 7, 11
Pediatric									P	P: 5, 6, 7, 11
Small Organs [1]									P	P: 5, 6, 7
Neonatal Cephalic									P	P: 5, 6, 7
Adult Cephalic									P	P: 5, 6, 7
Cardiac [2]								P	P(9)
Transesophageal (Cardiac)										P: 5, 6, 7
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P	P	P	P	P			P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations
	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
Fetal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 10, 11
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6, 7, 11
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Fetal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 10, 11
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Pediatric	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Adult Cephalic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 11
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Transrectal	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Transvaginal	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Transurethral	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Intravascular	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Laparoscopic	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5.6.7.11
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P
Fetal	P		P			P	P			P: 5, 6, 7
Abdominal		P		P	P		P
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, 7
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)							P			P: 5, 6, 7
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: 5, 6, 7, 11
Fetal	P	P	P		P	P	P			P: 5, 6, 7, 10, 11
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
Transvaginal	P	P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Transurethral										P: 5, 6, 7, 11 E: 8
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)						P	P			P: 5, 6, 7, 8, 11

Small Grains, Row Crops, Hay and Pasture

M.D., Neurology, Stroke | Neuro Block
(Neurology) Cardiac Arrest and Pediatric

Musculo Skeletal - Nerve Block

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

Solubility of Compound in Selected Solvents (mg/mL)

(6)3D/4D

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[8] Elastos
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(10) CITI

Fetal Navigation
Quantitative Elastosonography (QELA)

Previously cleared via K153277
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6250

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[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

Combined Modes are D, R, N, CP, CH, CM
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[6] 3D/4D
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[a] 3D/4+
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Elastosonography
[7] CMM

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Previously cleared via K15327
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CA123 (6200 and 6250 systems)
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New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mvi)

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Solutions Include:

Software
Process Breakdowns
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[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

[7] CMM

Elastosonography

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|| Nambara | Marie | Marie ||| Dombound Images | Partige || || Div

110cm

[11] Virtual Navigator

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

Previously cleared via K15327

saote K163082 Response to Request for Addition Station Collice of In Vitro Diagnostics (OlVD)

{7}------------------------------------------------

A431 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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

11.1.2.1. Optimal Strategies for Including Biomarkers in Clinical Trials and Personalized Medicine

[2] Cardiac Is Adult and Pediatric.

[3.] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

[6]3d

[7] CMM

Elastosonosaurus

|| Buall Organis Includes Eneady Thiroid and Testions
|| National Industrials: | September | Periodes
|| Nambara | Marie | Marie ||| Dombound Images | Partige || || Div

Carroll
Opacity
Microbial
Recurrence
Order
Antibiotic
Specialized
Clarification
Verification
Earlier
be left
of
authorization
and,
clarify
[i.e.,
Verifying
correct
application
of
Carroll
Opacity
Microbial
Recurrence
Order
Antibiotic
Specialized
Clarification
Verification
Earlier
be left
of
authorization
and,
clarify
[i.e.,
Verifying
correct
application
of

Trichan

[11] Virtual Navigator.

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

Previously cleared via K15327

saote K163082 Response to Request for Addition Station Collice of In Vitro Diagnostics (OlVD)

{8}------------------------------------------------

CA541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

w indication; P: Previously cleared by FDA; E:Added under Append

CT Scans: Organs thickness increases. Breast, Thymus and Parathyroid.

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

[6]3D

[7]CMM

|8|
Elastosonography

11 Bankla Previous Parast, Thirodd and Testides
11 National Marcus - Marcus - March Arabel - Maria - Partides
11 Comments - March 1-19-14 - Currentares
17 Dinament - Maria -

endocranial
border
of the left
coronalization
of the
visualization

[10] Chiti

[11] Virtual Navigation

[10] CnTI
[11] Virtual Navigator
[12] Quantitative Elastosonography (QElaXto) (6200 only

Previously cleared via K15327

Esaote K163082 Response to Request for Addition Stightige. Use Only Per 21 CFFR 801 Part D Concurrence (OVVD)

{9}------------------------------------------------

A631 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human books of a

w indication; P: Previously cleared by FDA; E:Added under Append

Southern Oregon Breast
Partners Breast Health
and Research

[2] Cardiac Is Adult and Pediatric.

3D Wilson - Pectoral Nerve Block

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

[15] Compound Imaging (Myview)

[6] 3D

[17] CMM

Elastosonography

1 Sunning States Press. Exemple of Comment
1978 - 1992 - 1992 - 1999 - 1999 - 1999 - 1999
1999 - 1992 - 1992 - 1999 - 1999 - 1999 - 1999 - 1999
1999 - 1992 - 1992 - 1992 -

Indo-Pacific border cell arterialization of the left ventricle

[110] CrTi (6200 only)

11] Virtual Navigator
10] Quantitative Electron Microscopy

DYNAMIC ELASTIC MODULUS (GPA)

Previously cleared via K15327

saote K163082 Response to Request for Addition Use Only Per 2 1 CFF 801 Part D Concurrence
s and Response to Request for Addition office of In Vitro Diagnostics and Rediologi

{10}------------------------------------------------

C3123 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

Small Organs includes Breast, Thyroid and Testicle:
Cardiac is Adult and Pediatric
Musculo Skeletal - Nere Block
Combined modes are: Be+M+DW+CW+CW+CW+CW+PD
Compound Imaging (

[2] Cardiac is Adult and Pediatric.

SCI. Musculoskeletal - Nerve Block

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

[5] Compound Imaging (MView)

[6] 3D

[7]
CMM

[8] Elastosonography

(4) Combined modes are: B+M+PW+CW+CFM+PD
(6) SDM
(7) CDM
(3) Chambond Imaging (Mricw)
(8) Elianaonoments)
(8) Mullades of the Left Pentricular for befl ventricle opacificatio

ISOCRATES, WRITINGS, 100-101, TO NICOCLES

order

judicial

particular

clarification

left vector

the

visualization

10] CnTI

[11] Virtual Navigator

[1 1] Virtual Navigator
[12] Quantitative Elastosonography (QElaXt

Previously cleared via K15327

saote K163082 Response to Request for Addition Striction in Crice of In Vitro Diagnostics (OlVD)

{11}------------------------------------------------

12C41 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human book of f

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

11 Small Organa includes Breast, Thyroid and Teeticle
13) Murdial is Adult and Pedialink
13) Murdial is Acadela - 18:13 AM-PD
18 Murdine Bledela - 19:13 M-PW-CW+CFM+PD
17 CMM

2] Cardiac is Adult and Pediatric

Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

[5] Compound Muster
[6] 3D

[?]SD [?]CMM

[7] CMM
[8] Elastosonos

Elastosonography
[8]
[9] Includes contrast (CnTI) in Adult Cardiac -

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

[9] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and
uiquoligation of the left ventriculor endocordiol border

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

[10], ChiTi
[11] virtual Navigator

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

Previously cleared via K15327

isaote K163082 Response to Request for Addition J.Jse Only Per 21 CFF 801 Part D Concurrence of
tealth (ORF

{12}------------------------------------------------

C3121 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

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

DESCRIPTION and FORMULATION

1st Choice Breast Dream includes:

[2] Cardiac is Adult and Pediatric

ਜ ਕ ਨ

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatrio
Museulo Skeletal - News Block
Combined modes are: IB+M+PW+CW+CW+CDFM+PD
Compound Imaging (Mr

[5] Compound Imaging (MrView)

[5] Compound Imaging (MVIEW)
[2D]

[6] 3D
[7] CMM

[7] CMM

[8] Elastosonometry

|| Combound masting (Morella) | Program Price operification a
|| Landsonography
| Juliansenors |
| July Child Cortifical Le Cardinal Le Carder Learteriale opacification a
| J

INSTRUCTION TO THE VOTER: TO VOTE, COMPLETELY FILL IN THE OVAL) NEXT TO YOUR CHOICE. USE ONLY A #2 PENCIL. IF YOU SPOIL OR MAKE A MISTAKE, RETURN THE BALLOT TO AN ELECTION OFFICIAL AND OBTAIN ANOTHER ONE. DO NOT ERASE. DO NOT WRITE IN. DO NOT FOLD. DO NOT REMOVE THIS BALLOT FROM THE POLLING PLACE.

[O/Chl]

Virtual Navigator,

Quantitative Elastosonography (QEI)

Previously cleared via K15327

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

{13}------------------------------------------------

A332 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll

under Appendix ion; P: Previously cleared by FDA;

Somerville Scientific, Inc., dba/trade name as B.R.I. Test. Approved and certified for service.

[2] Cardiac is Adult and Pediatric

3 Musculo Skeletal - Nerve Block

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

5 Compound Image (NIRview)

[6]3D

[6] 3D
[7] CAD

[8] Elastosonometry

ical endocentric
visualisation of the effective
borderline of the

Longhorn

Virtual Navigator
Quantitative Elastosonography (Q-Ela)

Previously cleared via K15327

LES ÉCOLES D'ÉTÉ DE L'INSTITUT DU NUMÉRIQUE RESPONSABLE 2024
Summer Schools of the Institute for Responsible Digitalization 2024
Date: 63082024
Request for Additional Information

{14}------------------------------------------------

LA435 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow of

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

ptica

Z. Cai, R.S. Nathwani, P. Scardino, and H. Rischke, "

Brachial Plexus Skeletal - Nerve Block

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

[5] Compound Imaging (NIRview)

(6) 3D

[2]
CMM

[8] Elastosonography

Clinical Trials for Icatibant Acetate Injection

Adult subjects (n=111) with acute attacks of hereditary angioedema (HAE) were treated in three controlled clinical trials (two double-blind, placebo-controlled, and one open-label, uncontrolled) with icatibant acetate injection. Subjects ranged in age from 18 to 75 years and were predominantly Caucasian (96%). All subjects received a single subcutaneous injection of 30 mg icatibant acetate for treatment of HAE symptoms. Additional injections of icatibant acetate injection could be administered if there was insufficient relief of symptoms. In the two placebo-controlled trials, the primary efficacy endpoint was the median time to onset of symptom relief, defined as the time when the subject first indicated that their primary symptom had started to improve, using a patient-reported visual analog scale (VAS). In the open-label trial, the primary efficacy endpoint was the proportion of subjects with improvement in their primary symptom at 4 hours.

In the two placebo-controlled trials, the median time to onset of symptom relief was 2.0 hours for icatibant acetate injection compared to 12.0 hours for placebo (p<0.001). In the open-label trial, 77% of subjects experienced improvement in their primary symptom at 4 hours after treatment with icatibant acetate injection.

In these three trials, 8% of subjects treated with icatibant acetate injection required a second dose for relief of their HAE symptoms. In controlled clinical trials, up to 3 repeat doses of icatibant acetate injection were allowed within a 24-hour period. Safety and efficacy of additional doses beyond 3 within 24 hours have not been established.

There is no evidence that icatibant acetate injection is effective for acute HAE attacks affecting the larynx. One subject with a laryngeal attack was treated with icatibant acetate injection in the open-label trial. This subject required intubation.

Oceanography

TolC-CHis

[10] CNN,
[11] Virtual Navigator

(12) Quantitative Electrosonogram

Previously cleared via K15327

{15}------------------------------------------------

A522 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human

Appendix under on; P: Previously cleared by FDA; E:Added |

U.S. Small Grains Includes Barley, Rye, Oats, and Pastures

Cardiac is Null and Pediatric
Musculo Skeletal, Neuro Block

Musculo-Skeletal, Neuro Block
Combined modes are: RAM + DIV + CC

REC COMBINED INDEXES & STRIP CHART
REC COMBINED INDEXES & MINIMUM

|6|3D
[a] modulus

[q] 3D
[z] CMM

[2] CMM

[8] Elastosonography

MEXICO BORDER: AT NEAR RECORD LEVELS, OFFICIALS SAY

BORDER PATROL: 2.4 MILLION ENCOUNTERS IN FISCAL YEAR

IMMIGRATION IS A TOP POLITICAL ISSUE

lo[ Cntr (6200 only)

11 Virtual Navigator

11] Virtual Navigator
12] Quantitative Elastosonography

Previously cleared via K15327

{16}------------------------------------------------

A523 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human

Appendix under on; P: Previously cleared by FDA; E:Added |

ALL Small Organs includes Breast, Thyroid and Testicles

Cardiac S. Anesth. and Pediatric
Musculo Skeletal / Nerve Block
Musculo SKELETAL - NERVE Block

Combined modes are: B+M, B+PV, B+C

Combined Modes are: D, N, R, 1, 2, M
Combined Modes are: N, D, M, R

[6] 3D Convolutional Neural
Networks for Human Action
Recognition

[6] 3D
[7] CMM

[7] CMM
[8] Flastson

8] Elastosonography
9] Includes contrast (CnTI) in Adj

VISUALIZATION OF THE LEFT VENTRICULAR ENDOCARDIUM

VOLUMETRIC (3D) MODEL

11 Virtual Navigator
of CMM (C200 only)

11] Virtual Navigator
10] Quantitative Electroencephalography

Previously cleared via K15327

{17}------------------------------------------------

A533 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

Appendix on; P: Previously cleared by FDA; E:Added under

Small Organs (includes Brains), Thyroid, and Testicles

Cardiac & Adult and Pediatric
Musculoskeletal - Nerve Block

[3]

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

IEC Combined Modes (IEC, B, IEC+IAI, C, IEC+PM, C+PM)
IEC Combined Power (IEC, B, IEC+IAI, C, IEC+PM, C+PM)

[6]3D

[6] 3D
[7] CMM

[7] CMM
[8] Elastosonometry

[8] Elastosonography

Radial endocavitary ultrasound visualization of the left vocal cord tumor extension

John Carroll

University

[11]. Virtual Navigator

[12] Quantitative Elastosonography

Previously cleared via K15327

ുറ Prescription Use Only Per 21 CFR 801 Part D Concurrence

{18}------------------------------------------------

_3116 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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

Small Organs includes Breast, Thyroid and Testicle
Cardiac is Adult and Pediatrio
Musculo Skeletal - Nereliatric
Combined models are: IB+M+FW+CFM+PD
Compound Imaging (Mriew) [ T

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Myview)

[6]3D

: [7] CMM

Elastosonos
Civil

[28] Elastosonography

Museus Sikeler - Norve Blog - Prevents - Pressent - Provention - Provinsioner - Provinciale - Provinciale - Provinciale opacification and Serviciole opacification a

WARNING: IMPROPER INSTALLATION, ADJUSTMENT, ALTERATION, SERVICE OR MAINTENANCE CAN CAUSE INJURY OR PROPERTY DAMAGE. REFER TO THE OWNER'S MANUAL PROVIDED WITH THIS APPLIANCE. FOR ASSISTANCE OR ADDITIONAL INFORMATION CONSULT A QUALIFIED INSTALLER, SERVICE AGENCY OR THE GAS SUPPLIER.

10] CnTI

[11] Virtual Navigator

[1 1] Virtual Navigator
[12] Quantitative Elastosonography (QElaXt

Previously cleared via K15327

saote K163082 Response to Request for Addition Striction in Crice of In Vitro Diagnostics (OlVD)

{19}------------------------------------------------

A023 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body i

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

Small Organs monitors Breast, Thyroid, and Pesticides

2] Cardiac is Adult and Pediatric
3] Musculo Skeletal - Nerve Block

Combined modes are: B, B+M, B+PW, B+CF

Combined modes are, B+M+C+Mview

5] Compound Imaging (Mview)

[6] 3D

[6] 3D
[7] CMM

[7] CMM
[8] Elastosonography

[6] Includes contrast (Cn.Tr.) in Adult Cardiac

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

[lol] Cntl

[11] Virtual Navigator

Virtual Navigator

Previously cleared via K15327

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

{20}------------------------------------------------

A122 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human

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

[1] Small Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block

(A) Combined modes are: B+M+PW+CI
(B) Module Division: Turbo Block

E3 Compound Imaging (Niveau)
E1 Combined images are, D, W or C in

[6]3D
[c] Inductor

[6] 3D
[7] CMM

[7] CMM
[8] Elastosonography

[8] Elastosonography

Friction

[11] Virtual Navigator

Virtual Navigator
Quantitative Elastoson

Previously cleared via K15327

{21}------------------------------------------------

A230 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body i

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

All Organs includes Breast, Thyroid, Fat and Testicles

Cardiac,S, Renal, and Pediatric
Musculo Skeletal - Nerve Block
Combined modes are: B+M+N+PW+CF

Combined modes as C, D, N, P, W, CW, M
Compound Imaging (Nview)

|6|3D
[6]mod

[6] 3D
[7] CMM

[7] CMM
[8] Elastosonometry

[8] Elastosonography

visualization of the left ventricular endocardial
10 cm

[11] Virtual Navigator

Previously cleared via K15327

{22}------------------------------------------------

A240 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body i

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

Small: Organs include Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block

(4) Combined modes are, B+M+PW+CI

[5] Compound Imaging (M-View)

C [6]3D

[2] CMM

[7] CMM
[8] Elastosonography

[9] Includes contrast (CnTI) in Adult Cardiac for left ventric
qualination of tea loft unuiaulan andanandial band

[10] Ctrl
[11] Virtual Navigator

[11] Virtual Navigator

[12] Quantitative Elastosonography

Previously cleared via K15327

{23}------------------------------------------------

C441 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

Appendix tion; P: Previously cleared by FDA; E:Added under lew

[1] Small Organs includes Breast, Thyroid and Testicles

101 Canding in Adult and Radiatio

Cardiac, Aortic and Pediatric
Musculo Skeletal - Nerve Block
Combined modes are: B+M+M+PW+CF

15 Compound Imaging (M-VIEW)

(6) 3D/4D

[6] 3D/TP
[7] CMM

[8] Elastosonography

Includes Vistas, City, Aqua, Cascade for left ventricle opacification (LV). Adequate for left ventricle cardiac border visualization of the left ventricular endocardial border.

[10] Ctrl
[11] Virtual Navigator

[11] virtual Navigator

Previously cleared via K15327

{24}------------------------------------------------

_433 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human Int

Appendix under on; P: Previously cleared by FDA; E:Added

[11] Small, All Organs, Brain, Breast, Thyroid, and Testicles

21 Cardiac Anesthesia, Pain and Pediatric
22 Musculo Skeletal - Nerve Block

[4] Combined modes are: B: B+M: B+PV+PW+CR

15 Compound Imaging (M-view)

c [6] 3D/4D

[6] 3D/TD
[7] CMM

[8] Elastosonography

Fossil Cell
Pt. 1, No. 1, Series 1914

[11] virtual Navigator

Previously cleared via K15327

{25}------------------------------------------------

123 (6200 and 6250 systems)
ted use: Diagnostic ultrasound imaging or fluid flow analysis of human body i

Appendix tion; P: Previously cleared by FDA; E:Added under lew 10 | ž

Cellular Organs includes Brains, Breast, Thyroid and Testicles

Cardiac Arrest
Cardiac Arrest and Pediatric
Musculo Skeletal - Nerve Block

(4) Combined modes are: B+M+PW+CF

4] Combined modes as in D'Amico et al. (2017)

5] Compound Imaging (M-view)

(6)[3D/4D

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

7] CMM

8] Elastosonography

Sanal Previous Petirean, There and Teatrace
13 Russiale Provincial Proved and Teatrine
13 Russiale Provincial Provincial Provention
13 September 1947 - 1947 - 1997

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

visualization of the left ventricular endocardial border

[Flo Chu]

[11] Virtual Navigator

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

Previously cleared via K15327

{26}------------------------------------------------

C123 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body i

cation; P: Previously cleared by FDA; E:Added under Appendix Jew

Some Milk Organs includes Breast, Thyroid and Testicles

Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block

[4] Combined modes are, B+M+PW+C

E5 Compound Imaging (M-view)

c [6]3D

[5] 2D
[7] CMM

[7] CMM
[8] Elastoson

[8] Elastosonography
[9] Includes contrast

Front Card

[11] Virtual Navigator

[11] virtual Navigator

Previously cleared via K15327

{27}------------------------------------------------

C1123 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P		P: 5, 6, 7, 11
Abdominal	P	P	P	P	P	P	P	P: 5, 6, 7, 10, 11
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
Transvaginal	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P: 5, 6, 7, 8, 11
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)					P	P		P: 5, 6, 7, 8, 11

Appendix cation; P: Previously cleared by FDA; E:Added under i ndi Jew and the many of the many of the many of the many of the mark of the mark of the states of the search and the first and the first and the first and the first and the first and

US Small Organs (Brain, Breast, Thyroid, other Tissues and Pesticides)

12 Cardiac Arrest and Pediatric
13 Musculo Skeletal - Nerve Block

Combined modes are: B, B+M, PW+CE

4] Combined modes are, B+M+C+N
5] Compound Imaging (M-View)

[6] 3D
component

[6] 5D
[7] CMM

[7] CMM
[8] Elastosonography

|8| Elastosonography
(a) Includes corre

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

visualisation of the left ventricular endocardial border

[10] CH11
[11] Virtual Navigator

[11] Virtual Navigator.

[12] Quantitative Elastosonography

Previously cleared via K15327

{28}------------------------------------------------

E022 (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

Clinical Application	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P		P	P
Transesophageal (Non Cardiac)
Transrectal									P: 5, 6, 7
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic						P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

Appendix cation; P: Previously cleared by FDA; E:Added under i ndi Jew 0

[1] Small Organs including Breast, Thyroid and Testicles
[2] Animal, Plant and Pesticides

Cardiac Anesthesia and Pediatric
Musculo Skeletal - Nerve Block

4] Combined modes are: B+M+PW+C

Combined modes are: B, BNP, V, VCN, and VCP.
Compound Imaging (Merge View)

[6|3D]
[p] Source: rndmod

3D
[6]
CMM
[7]

[7] CMM
[8] Elastosone

[8] Elastosonography
(a) Includes sonoelastography

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

: Visualization of the left ventricular endocardial border

10 cm

[10] CH11
[11] Virtual Navigator

[11] Virtual Navigator

[12] Quantitative Elastosonos

Previously cleared via K15327

{29}------------------------------------------------

E132 (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

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

Appendix cation; P: Previously cleared by FDA; E:Added under i ndi Jew

TCS Italian Organics Brazil, Thyroid and Pesticides

Cardiac Adult and Pediatric
Musculo Skeletal - Nerve Block

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

ES Compound Imaging (NView)

c [6] 3D

[6] 3D
[7] CMM

[7] CMM
[8] Elastosonography

[8] Elastosonography
(a) Includes compression

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

[10] Ctrl

[11] Virtual Navigator

[11] virtual Navigator

Previously cleared via K15327

{30}------------------------------------------------

E323 (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	P: 5, 6, 7
Abdominal	P	P	P	P	P	P	P	P: 5, 6, 7, 10
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P: 5, 6, 7
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P: 5, 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P: 5, 6, 7, 8
Neonatal Cephalic	P	P	P	P	P	P	P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P		P	P	P	P	P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P: 5, 6, 7
Other (Urological)	P		P	P	P	P	P	P: 5, 6, 7

ion; P: Previously cleared by FDA; E:Added under Appendix lew

SOIL ORGANIC MATTER, IRRIGATION, AND PESTICIDES

Cardiac Arrest and Pediatric
Musculo-Skeletal - Nerve Block

Musculo-Skeletal, Nerve Block
Combined modes are: R+M, R+N, M+N, R+M+N

EPC Combines Modes A, B and P in CPM
EPC Combines P, AM, and FM in CPM

(6)3D

[q] 3D
[Z] CMM

[17] CMM
[18] Elastosonos

] Elastosonography
g] Includes contrast

Visualization of the left ventricular endocardial border

For Ctrl

[11] Virtual Navigator

11] Virtual Navigator
12] Quantitative Electron

Previously cleared via K15327

{31}------------------------------------------------

OT342 (6200 and 6250 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Abdominal	P	P	P		P	P	P		P
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5, 6, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5, 6, 7, 11
Other (Urological)	P		P			P	P		P	P: 5, 6, 7, 11

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

IISc Special Congress Brussels, M. Tryfonidou, Plant Protection Products and Pesticides

12 Cardiac, Renal and Pediatric
32 Wilson St, Suite 1, North Block

[3]

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

EC COMBINED modes are, BIPVT, CPIVT
EC Combined Power, Maximum Power

uction
|6| 3D

[6] 3D
171CMM

[7] CMM
[6] PI

[8] Elastoson

visualization of the left ventricular endocardial border.

f CHFI (B200 only)
11 Virtual Navigator

11] Virtual Navigator
10] Quantitative Electro

Previously cleared via K15327

{32}------------------------------------------------

P323 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P			P: 5, 6, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7, 10
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7
Small Organs [1]	P	P	P		P	P	P		P	P: 5, 6, 7
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, 6, 7
Laparoscopic	P	P	P		P	P	P		P	P: 5, 6, 7
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

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

Small Organs includes Breast, Thyroid, and Testicles

2] Cardiac is Adult and Pediatric
3] Musculo Skeletal - Nerve Block

Musculo Skeletal ACTIVE Block
Combined modes are, B, B+M, PW+C

5.1 Combined Modes a.c. D.T.T. C.W.

5.3 Compound Marine Mixer

(6) [3D]

CMM
Z2SP

7] CMM
8] Elastosonography

[8] Elastosonogra
(n) Includes contras

[10] cntl
11

[11] Virtual Navigator

[11] Virtual Navigator
(10) Orbiting Platform

Previously cleared via K15327

{33}------------------------------------------------

733 (6200 and 6250 systems)
ded use: Diagnostic ultrasound imaging or fluid flow analysis of human body a

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P
Fetal		P	P		P	P	P		P	P: 5, 6, 7, 11
Abdominal							P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal		P	P		P	P	P		P	P: 5, 6, 7, 8, 11
Transvaginal
Transvaginal		P	P		P	P	P		P	P: 5, 6, 7, 11
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5, 6, 7, 11 E: 8

Appendix ation; P: Previously cleared by FDA; E:Added under Jew

Small Organs (includes Brains), Thyroid, and Testicles

12 Cardiac, Aortic, and Pediatric
32 Musculo Skeletal - Nerve Block

Combined modes are, B, B+M+PW+CI

Combine modes are, D, M, TV, S, C, P. (Creative modes are, B, M, TV, S, C, P.)
Compound Imaging Menu

[6] 3D

[6] 3D
[7] CMM

|7| CMM
|8| Flastonsono

[8] Elastosonography
[9] Intraductal

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

[Cr]t

111 Virtual Navigator

[12] Quantitative Dissolution Technologies

Previously cleared via K15327

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

{34}------------------------------------------------

:W (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as a

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix

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

US Chemicals in Breast, Thyroid, and Testicles

Cardiac Anesthesia and Pediatric
Musculo Skeletal - Nerve Block

[4] Combined modes are: B; B+M; B+PW; B+CF

FE Combined Indices a.c. D.M.T.W.Cr.
FE Compound Indices (Mean)

[6] 3D
produce

[6] 3D
[7] CMM

|7| CMM
|8| Elastosonography

[8] Elastosonography

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

[log] Cnt

[11] Virtual Navigator

[11] Virtual Navigator
[10] Ourti, in: Flat-Earth

Previously cleared via K15327

{35}------------------------------------------------

:W (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as a

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

indication; P: Previously cleared by FDA; E:Added under Appendix New 00

[1] Small Organs including Brain, Thymus, Breast, Thyroid, and Testicles

[2] Animal Feed and Pesticides

Cardiac is Adult and Pediatric
Musculo Skeletal - Nerve Block

(4) Combined modes are: B; B+M; B+M+PW; B+M+PW+CF

5.3 Compound Imaging (NEW)
5.4 IEC Compound Imaging for cohort portraits

C 6

[2] CMM

[7] CMM
[8] Elastosonography

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

[110] CrTi

[11] Virtual Navigator

[11] virtual Navigator

Previously cleared via K15327

{36}------------------------------------------------

FCW (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as f

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

US Small Organs (includes Breast, Thyroid, and Testicles)

2] Cardiac is Adult and Pediatric
3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CI

5.3 Compound Imaging (M-View)

C [6]3D

[5] 3D
[7] CMM

[7] CMM
[8] Elastoson

[8] Elastosonography
(b) Includes contrast

ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺮﺍﺟﻊ

visualization of the left ventricular endocardial border

111 Virtual Navigator [10], cnr

[11] Virtual Navigator

Previously cleared via K15327

{37}------------------------------------------------

2MPW (6200 and 6250 systems)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as f

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

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

Previously cleared via K1532

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

{38}------------------------------------------------

6-18 (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P	P: 5 E: 6, 7
Abdominal	P	P	P	P	P	P	P	P	P: 5, 10 E: 6, 7
Intraoperative (Abdominal)	P	P	P	P	P	P	P	P	P: 5 E: 6, 7
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P: 5 E: 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P	P: 5 E: 6, 7, 8
Neonatal Cephalic	E	E	E	E	E	E	E	P	P: 5 E: 6, 7
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 E: 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P: 5 E: 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P: 5 E: 6, 7
Other (Urological)	P	P	P	P	P	P	P	P	P: 5 E: 6, 7

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

US Small Organs includes Breast, Thyroid and Testicles

Cardiac's Adult and Pediatric
Musculo Skeletal - Nerve Block
Combined modes are B'+M+PW+CI

1.5 Compound Imaging (Macro, Micro, Review)

[6]3D

[9] 3D
[12] CMM

[7] CMM
[8] Elastosonography

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

[IgG] Ctrl
1/1000 anti-N-terminal

[11] Virtual Navigator

[12] Quantitative Elastosonography

Previously cleared via K161359

{39}------------------------------------------------

-8 (6200 and 6250 system)

ded use: Diagnostic ultrasound imaging ()

or fluid flow analysis of human body jul

Clinical Application	Mode of Operations								Other (specify)
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)		Harmonic Imaging (TEI)
Ophthalmic	N	N	N	N	N	N	N	N	N	N
Fetal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Abdominal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 10, 11, 12
Intraoperative (Abdominal)	N	N	N	N	N	N	N	N	N	N
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Pediatric	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Small Organs [1]	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac [2]	N	N	N	N	N	N	N	N	N	N
Transesophageal (Cardiac)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Transesophageal (Non Cardiac)	N	N	N	N	N	N	N	N	N	N
Transrectal	N	N	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N	N	N
Transurethral	N	N	N	N	N	N	N	N	N	N
Intravascular	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Laparoscopic	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Other (Urological)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11

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

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

To be cleared with this
submission

{40}------------------------------------------------

4-15 (6200 and 6250 system)
ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body a , 미

						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	N	N	N	N	N	N	N	N	N	N
Fetal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Abdominal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 10, 11
Intraoperative (Abdominal)	N	N	N	N	N	N	N	N	N	N
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Small Organs [1]	N	N	N	N	N	N	N	N	N	N
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 8, 11
Adult Cephalic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Cardiac [2]	N	N	N	N	N	N	N	N	N	N
Transesophageal (Cardiac)	N	N	N	N	N	N	N	N	N	N
Transesophageal (Non Cardiac)	N	N	N	N	N	N	N	N	N	N
Transrectal	N	N	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N	N	N
Transurethral	N	N	N	N	N	N	N	N	N	N
Intravascular	N	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Laparoscopic	N	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Musculo-skeletal Superficial [3]	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11
Other (Urological)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7, 11

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

[4] Combined modes are: BNP*W+CM+PD
[5] Compound Imaging (M-view)
[6] 3D

[6] 3D

[7] CMM
[8] Flastson

[8] Elastosonography.
[9] Includes contrast

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

[Tor/Cm]

[10] on.
[11] Virtual Navigator

[12] Quantitative Elastosonography

To be cleared with this
submission

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

{41}------------------------------------------------

PA250 (6200 and 6250 system)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body

	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	N	N	N	N	N	N	N		N	N: 5, 6, 7, 11
Fetal	N	N	N	N	N	N	N		N	N: 5, 6, 7, 10, 11
Abdominal	N	N	N	N	N	N	N		N	N: 5, 6, 7, 11
Intraoperative (Abdominal)	N	N	N	N	N	N	N		N	N: 5, 6, 7, 11
Intraoperative Neurological	N	N	N	N	N	N	N		N	N: 5, 6, 7, 11
Pediatric	N	N	N	N	N	N	N		N	N: 5, 6, 7
Small Organs [1]	N	N	N	N	N	N	N		N	N: 5, 6, 7
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N		N	N: 5, 6, 7
Cardiac [2]	N	N	N	N	N	N	N	N	N (9)	N: 5, 6, 7
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N	N		N	N: 5, 6, 7, 11
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)

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

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)

{42}------------------------------------------------

.2325 (6200 and 6250 system)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human nt

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations							Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]
Ophthalmic	N	N	N	N	N	N	N	N	N	N
Fetal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Abdominal	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P: 5; N: 6, 7
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5; N: 6, 7, 8
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5; N: 6, 7
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P: 5; N: 6, 7, 8
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5; N: 6, 7, 8
Other (Urological)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7

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

Previously cleared via K16135

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

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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 5816153 GenovaItaly
Contact Person:	Allison Scott, Managing Consultant317.228.8719 Office317.228.8701 Faxallison.scott@navigant.com
Date:	January 23, 2017
807.92(a)(2)
Devices
Common Name:	Ultrasound Imaging System
Trade Name:	6200 Ultrasound System6250 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging SystemUltrasound Pulse Echo Imaging SystemTransducer, Ultrasonic, Diagnostic	892.1550892.1560892.1570
Classification Number:	90IYN, 90IYO, 90ITX

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807.92(a)(3)

Predicate	510(k)	Device	Owner
Primary	K153277	6200 - MyLabTwice6250 - MyLabClass C	Esaote S.p.A.
		Virtual NavigatorSoftware
Reference	K130881	Acuson S3000	Siemens Medical Solution
Reference	K150239	FibroScan 502	EchoSens
Reference	K151451	Aplio 500/400/300V6.0	Toshiba Medical Systems
		Reference

Predicate Device(s)

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

807.92(a)(4)

Device Description

Both 6200 and 6250 models including the Virtual Navigator software option have been cleared via 510(k) 153277.

Both 6200 and 6250 upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with new capabilities, listed below:

. Implementation of the MyLabRemote feature on both 6200 and 6250 upgrades
। Addition of in Elastosonography (ElaXto) analysis in Intraoperative (Neurological) application on both 6200 and 6250 upgrades
-Management of Quantitative Elastosonographic analysis (QElaXto) in Abdominal application on 6200 upgrade

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-Implementation of the Automatic Nuchal Translucency feature on both 6200 and 6250 upgrades
-Addition of new probes on both 6200 and 6250 upgrades

Availability in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
-Availability of Elastosonography (ElaXto) analysis in Intraoperative (Abdominal) and Intraoperative (Neurological) applications in the Virtual Navigator upgrade environment
-Availability of Quantitative Elastosonographic analysis (QElaXto) for Abdominal application in the Virtual Navigator upgrade environment
-Navigation software new user interface on Virtual Navigator upgrade

The marketing names for 6200 and 6250 upgrades will be called MyLabEight respectively.

The different versions of 6200 and 6250 models and their upgrades are differentiated by part numbers.

Both 6200 and 6250 upgraded models are manufactured under an ISO 9001 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

Esaote's Model 6200 is a mainframe ultrasound system 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), Intraoperative (Neurological), Laparoscopic and Other: Urologic.

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

807.92(a)(6)

Technological Characteristics

Both 6200 and 6250 upgrades employ the same fundamental technological characteristics as their predicate devices.

The 6200 upgrade is substantially equivalent to Esaote 6200 model cleared via K153277, Siemens Medical Solution Acuson S3000 already cleared via K130881, EchoSens FibroScan 502, already cleared via K150239, Toshiba Medical Systems Aplio 500/400/300 V6.0 already cleared via K151451 and Hitachi Aloka Medical Arietta 70/S70/V70 already cleared via K134016.

The Virtual Navigator software option is substantially equivalent to Hitachi Aloka Medical Arietta 70/S70/V70, already cleared via K134016.

The 6250 upgrade is substantially equivalent to Esaote 6250 model cleared via K153277, Toshiba Medical Systems Aplio 500/400/300 V6.0 already cleared via K151451 and Hitachi Aloka Medical Arietta 70/S70/V70 already cleared via K134016.

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The Virtual Navigator software option is substantially equivalent to Hitachi Aloka Medical Arietta 70/S70/V70, already cleared via K134016.

Clinical uses for which Esaote 6200 and 6250 upgrades models are designed are equivalent to those of the previous 6200 and 6250 models, already cleared via K153277.
Both 6200 and 6250 upgrades for managing Elastosonography (ElaXto) analysis in Intraoperative (Neurological) applications is equivalent to those of Hitachi Aloka Medical model Arietta 70/S70/V70, already cleared via K134016.
6200 upgrade including the Quantitative Elastosonographic analysis (QElaXto) for Abdominal application is equivalent to those of Siemens Medical Solution Acuson S3000, already cleared via K130881 and EchoSens FibroScan 502, already cleared via K150239.
Both 6200 and 6250 upgrades including the AutoNT feature, is equivalent to those of Toshiba Aplio 500/400/300 V6.0, already cleared via K151451.
The 6200 upgrade, 6250 upgrade, 6200, 6250, Acuson S3000, FibroScan 502, Aplio 500/400/300 V6.0 and Arietta 70/S70/V70 ultrasound models are designed to meet the IEC 60601-1 and IEC 60601-2-37 safety requirements.
The 6200 upgrade, 6250 upgrade, 6200, 6250, Acuson S3000, FibroScan 502, Aplio 500/400/300 V6.0 and Arietta 70/S70/V70 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
The 6200 upgrade, 6250 upgrade, 6200, 6250, Acuson S3000, FibroScan 502, Aplio 500/400/300 V6.0 and Arietta 70/S70/V70 ultrasound models provide similar measurements and analysis packages, with equal accuracy and precision.
The 6200 upgrade, 6250 upgrade, 6200, 6250, Acuson S3000, FibroScan 502, Aplio 500/400/300 V6.0 and Arietta 70/S70/V70 ultrasound models have digital storage capabilities, including network connectivity.
The 6200 and 6250 upgrades imaging modes are available on other FDA cleared ultrasound systems, for instance 6200 and 6250 models

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807.92(b)(1)

Summary of Non-Clinical Tests

The 6200 and 6250 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, identical to the predicate and reference devices.

IEC 60601-1 Ed. 3.0 (2005-12) Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Corrigendum 1:2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Corrigendum 2:2007 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. Amendment 1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Ed. 3.0 (2007-03) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and Tests.
IEC 60601-2-37 Ed. 2.0 (2007-08) Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
· NEMA Standards Publication UD 2-2004 Revision 3 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
· NEMA Standards Publication UD 3-2004 Revision 2 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

Both 6200 and 6250 upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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.