Esaote's Model 6425 Ultrasound System 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. The 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.

Device Description

The model 6425 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes. Model 6425 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Esaote S.p.A Model 6425 Ultrasound System. It details how the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it demonstrates substantial equivalence to predicate devices for its intended uses and technological characteristics. The "performance" is implicitly deemed acceptable if it matches or is comparable to the already cleared predicate devices.

The acceptance criteria are implied to be meeting the safety and performance standards of the predicate devices (Model 6400 and Model 6420) and conforming to relevant medical device safety standards.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Intended Use Equivalence	Clinical uses for the Model 6425 are equivalent to Model 6400. The device performs diagnostic general ultrasound studies including various listed applications.
Technological Equivalence	Employs the same fundamental technological characteristics as predicate devices (Model 6400 and Model 6420). Key image modes are available on these cleared systems.
Safety Standard Conformity	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, and NEMA UD 3-2004.
Acoustic Output Display	Provides an Acoustic Output Display feature per AIUM/NEMA standards, with equivalent Ispta and MI maximal values to predicates.
Measurement Accuracy	Provides a similar measurements and analysis package, with equal accuracy and precision as predicate devices.
Digital Storage	Has digital storage capabilities, including network connectivity, similar to predicate devices.
Biocompatibility	Evaluated as part of non-clinical tests.
Cleaning & Disinfection	Evaluated as part of non-clinical tests.
Thermal & Mechanical Safety	Evaluated as part of non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical tests were performed." Therefore, there is no test set sample size or data provenance related to clinical performance in this submission. The basis for clearance is substantial equivalence to previously cleared devices which would have undergone testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical tests were performed for this specific submission, there is no information regarding experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical tests were performed, there is no mention of an adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, the document explicitly states, "No clinical tests were performed." Therefore, no MRMC comparative effectiveness study was conducted for this submission. The device is cleared based on demonstrating substantial equivalence to predicate devices, not on proving improved effectiveness with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is an "Ultrasound System," implying it is a hardware and software system for image acquisition and display, operated by a human. There is no mention of an "algorithm only" or "standalone" performance evaluation in the context of AI or automated analysis. The clearance is for the ultrasound system itself.

7. The Type of Ground Truth Used

Given that no clinical tests were performed, there is no information on a specific ground truth used for this submission. The clearance relies on the established safety and performance of the predicate devices.

8. The Sample Size for the Training Set

No information is provided regarding a training set as the submission focuses on substantial equivalence of a new ultrasound hardware system rather than an AI/ML algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of an AI/ML algorithm, this information is not applicable and is not provided in the document.

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 symbol that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

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

October 14, 2016

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

Re: K162290

Trade/Device Name: Model 6425 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 28, 2016 Received: September 29, 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.

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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)

K162290

Device Name Model 6425 Ultrasound System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

aote SpA 6425 510(K)
Esaote 6425 Ultrasound System 510

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

6425

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일 위원 : 2017 : 2017 : 2017 : 2017 : 10:30 : 10 : 2017 : 10:30 : 10 : 2017 : 10 : 2017 : 10 : 2017 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 10 : 1 : 1 : 1 : 1
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Intended use: Diagnostic ultrasound Imaging or fluid flow analysis of human body as follows:
Clinical Application	Mode of Operations							Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler (AD)	Combined [4]
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	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	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)	P	P	P	P	P	P	P		P	P: 5
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	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	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P	P: 5
Transvaginal	P	P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional[3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal
Intraoperative (Abdominal)							P		P	P: 5
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P	P: 5
Transvaginal	P	P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
he TLC 3-13 probe is already clea	red via K161359
IIH 6-18Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)								P	P	P: 5
Transesophageal (Non Cardiac)								P	P	P: 5
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5
	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler (AD)	Combined [4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (sp
Ophthalmic
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)	P	P	P	P	P	P	P	P	P	P: 5
Intraoperative Neurological
LP 4-13ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
he LP 4-13 probe is already cleared via K161359
SB3123Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P
Fetal									P	P: 5, 7
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, 7
Transvaginal	P	P	P		P	P	P		P	P: 5, 7
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5, 7
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P
Fetal	P	P
Abdominal			P	P	P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric					P	P	P		P	P: 5
Small Organs [1]					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 (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5
he AC2541 probe is already cleared via K161350
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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)
SL1543Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
The SL1543 probe is already cleared via K161250
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	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
Musculo-skeletal Superficial [3]
Other (Urological)
he S2MCW probe in already olored wio K161350
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	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]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P	P: 5, 7
Abdominal	P	P	P	P	P	P	P		P	P: 5, 7
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)
SHFCW intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application						Mode of Operations
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular							P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
ST2612Intended use: Diagnostic						ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	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]
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)
the ST2612 probe is already cleared via K161359
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological	P	P	P		P	P	P		P	P: 5
Pediatric
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
Laparoscopic	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
SE3123Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(AD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P			P: 5
Fetal									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]	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]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P: 5
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P: 5
Cardiac [2]	P	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	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
SP2442ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: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	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: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)

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

【2C41 probe is already cleared via K1613

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﻣﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌ

Small Organs includes Breast, Thyroid

[2] Cardiac is Adult and Pediatric
N.Y.U. Langone Bl.

PW+CW+CEM

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

LC COMBINATION INDEX, B, M, P, C, AND
LC COMBINATION INDEX, M, P, C, AND

[5] Compound Imaging (MView)

[6] Includes contrast (Cni) in Adult Cardiac for left ventricle opacification and

1
C1 1
1
111
1

Visualization of 7L 3D/4D

{6}------------------------------------------------

THE FUTURE IS ALREADY HERE - IT'S JUST NOT VERY EVENLY DISTRIBUTED. - WILLIAM GIBSON

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

SCREENING FOR GENETIC MUTATIONS
IN BRCA1 AND BRCA2, AND OTHER CANCER PREDISPOSITION GENES

Myriad Genetic Services, Inc.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (NView)

N New Middeston, Fireviews Previous Price. Bidded under Appendas E
(3) Musicult end Personal Production March Manager Services
(3) Musicult and Proporto Cover March Productio

1/3D/4D

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

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

LFO Smallcap Strategic Beta ETF (FOUS) is designed to provide investment results that, before fees and expenses, correspond generally to the price and yield performance of the LFO Smallcap Strategic Beta Index.

[[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CW+CFM+F

[5] Compound Imaging (MVIEW), 1.1, 1.6, 1.8, 1.9, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0, 22.1, 22.2, 22.3, 22.4, 22.5, 22.6, 22.7, 22.8, 22.9, 23.0, 23.1, 23.2, 23.3, 23.4, 23.5, 23.6, 23.7, 23.8, 23.9, 24.0, 24.1, 24.2, 24.3, 24.4, 24.5, 24.6, 24.7, 24.8, 24.9, 25.0, 25.1, 25.2, 25.3, 25.4, 25.5, 25.6, 25.7, 25.8, 25.9, 26.0, 26.1, 26.2, 26.3, 26.4, 26.5, 26.6, 26.7, 26.8, 26.9, 27.0, 27.1, 27.2, 27.3, 27.4, 27.5, 27.6, 27.7, 27.8, 27.9, 28.0, 28.1, 28.2, 28.3, 28.4, 28.5, 28.6, 28.7, 28.8, 28.9, 29.0, 29.1, 29.2, 29.3, 29.4, 29.5, 29.6, 29.7, 29.8, 29.9, 30.0, 30.1, 30.2, 30.3, 30.4, 30.5, 30.6, 30.7, 30.8, 30.9, 31.0, 31.1, 31.2, 31.3, 31.4, 31.5, 31.6, 31.7, 31.8, 31.9, 32.0, 32.1, 32.2, 32.3, 32.4, 32.5, 32.6, 32.7, 32.8, 32.9, 33.0, 33.1, 33.2, 33.3, 33.4, 33.5, 33.6, 33.7, 33.8, 33.9, 34.0, 34.1, 34.2, 34.3, 34.4, 34.5, 34.6, 34.7, 34.8, 34.9, 35.0, 35.1, 35.2, 35.3, 35.4, 35.5, 35.6, 35.7, 35.8, 35.9, 36.0, 36.1, 36.2, 36.3, 36.4, 36.5, 36.6, 36.7, 36.8, 36.9, 37.0, 37.1, 37.2, 37.3, 37.4, 37.5, 37.6, 37.7, 37.8, 37.9, 38.0, 38.1, 38.2, 38.3, 38.4, 38.5, 38.6, 38.7, 38.8, 38.9, 39.0, 39.1, 39.2, 39.3, 39.4, 39.5, 39.6, 39.7, 39.8, 39.9, 40.0, 40.1, 40.2, 40.3, 40.4, 40.5, 40.6, 40.7, 40.8, 40.9, 41.0, 41.1, 41.2, 41.3, 41.4, 41.5, 41.6, 41.7, 41.8, 41.9, 42.0, 42.1, 42.2, 42.3, 42.4, 42.5, 42.6, 42.7, 42.8, 42.9, 43.0, 43.1, 43.2, 43.3, 43.4, 43.5, 43.6, 43.7, 43.8, 43.9, 44.0, 44.1, 44.2, 44.3, 44.4, 44.5, 44.6, 44.7, 44.8, 44.9, 45.0, 45.1, 45.2, 45.3, 45.4, 45.5, 45.6, 45.7, 45.8, 45.9, 46.0, 46.1, 46.2, 46.3, 46.4, 46.5, 46.6, 46.7, 46.8, 46.9, 47.0, 47.1, 47.2, 47.3, 47.4, 47.5, 47.6, 47.7, 47.8, 47.9, 48.0, 48.1, 48.2, 48.3, 48.4, 48.5, 48.6, 48.7, 48.8, 48.9, 49.0, 49.1, 49.2, 49.3, 49.4, 49.5, 49.6, 49.7, 49.8, 49.9, 50.0, 50.1, 50.2, 50.3, 50.4, 50.5, 50.6, 50.7, 50.8, 50.9, 51.0, 51.1, 51.2, 51.3, 51.4, 51.5, 51.6, 51.7, 51.8, 51.9, 52.0, 52.1, 52.2, 52.3, 52.4, 52.5, 52.6, 52.7, 52.8, 52.9, 53.0, 53.1, 53.2, 53.3, 53.4, 53.5, 53.6, 53.7, 53.8, 53.9, 54.0, 54.1, 54.2, 54.3, 54.4, 54.5, 54.6, 54.7, 54.8, 54.9, 55.0, 55.1, 55.2, 55.3, 55.4, 55.5, 55.6, 55.7, 55.8, 55.9, 56.0, 56.1, 56.2, 56.3, 56.4, 56.5, 56.6, 56.7, 56.8, 56.9, 57.0, 57.1, 57.2, 57.3, 57.4, 57.5, 57.6, 57.7, 57.8, 57.9, 58.0, 58.1, 58.2, 58.3, 58.4, 58.5, 58.6, 58.7, 58.8, 58.9, 59.0, 59.1, 59.2, 59.3, 59.4, 59.5, 59.6, 59.7, 59.8, 59.9, 60.0, 60.1, 60.2, 60.3, 60.4, 60.5, 60.6, 60.7, 60.8, 60.9, 61.0, 61.1, 61.2, 61.3, 61.4, 61.5, 61.6, 61.7, 61.8, 61.9, 62.0, 62.1, 62.2, 62.3, 62.4, 62.5, 62.6, 62.7, 62.8, 62.9, 63.0, 63.1, 63.2, 63.3, 63.4, 63.5, 63.6, 63.7, 63.8, 63.9, 64.0, 64.1, 64.2, 64.3, 64.4, 64.5, 64.6, 64.7, 64.8, 64.9, 65.0, 65.1, 65.2, 65.3, 65.4, 65.5, 65.6, 65.7, 65.8, 65.9, 66.0, 66.1, 66.2, 66.3, 66.4, 66.5, 66.6, 66.7, 66.8, 66.9, 67.0, 67.1, 67.2, 67.3, 67.4, 67.5, 67.6, 67.7, 67.8, 67.9, 68.0, 68.1, 68.2, 68.3, 68.4, 68.5, 68.6, 68.7, 68.8, 68.9, 69.0, 69.1, 69.2, 69.3, 69.4, 69.5, 69.6, 69.7, 69.8, 69.9, 70.0, 70.1, 70.2, 70.3, 70.4, 70.5, 70.6, 70.7, 70.8, 70.9, 71.0, 71.1, 71.2, 71.3, 71.4, 71.5, 71.6, 71.7, 71.8, 71.9, 72.0, 72.1, 72.2, 72.3, 72.4, 72.5, 72.6, 72.7, 72.8, 72.9, 73.0, 73.1, 73.2, 73.3, 73.4, 73.5, 73.6, 73.7, 73.8, 73.9, 74.0, 74.1, 74.2, 74.3, 74.4, 74.5, 74.6, 74.7, 74.8, 74.9, 75.0, 75.1, 75.2, 75.3, 75.4, 75.5, 75.6, 75.7, 75.8, 75.9, 76.0, 76.1, 76.2, 76.3, 76.4, 76.5, 76.6, 76.7, 76.8, 76.9, 77.0, 77.1, 77.2, 77.3, 77.4, 77.5, 77.6, 77.7, 77.8, 77.9, 78.0, 78.1, 78.2, 78.3, 78.4, 78.5, 78.6, 78.7, 78.8, 78.9, 79.0, 79.1, 79.2, 79.3, 79.4, 79.5, 79.6, 79.7, 79.8, 79.9, 80.0, 80.1, 80.2, 80.3, 80.4, 80.5, 80.6, 80.7, 80.8, 80.9, 81.0, 81.1, 81.2, 81.3, 81.4, 81.5, 81.6, 81.7, 81.8, 81.9, 82.0, 82.1, 82.2, 82.3, 82.4, 82.5, 82.6, 82.7, 82.8, 82.9, 83.0, 83.1, 83.2, 83.3, 83.4, 83.5, 83.6, 83.7, 83.8, 83.9, 84.0, 84.1, 84.2, 84.3, 84.4, 84.5, 84.6, 84.7, 84.8, 84.9, 85.0, 85.1, 85.2, 85.3, 85.4, 85.5, 85.6, 85.7, 85.8, 85.9, 86.0, 86.1, 86.2, 86.3, 86.4, 86.5, 86.6, 86.7, 86.8, 86.9, 87.0, 87.1, 87.2, 87.3, 87.4, 87.5, 87.6, 87.7, 87.8, 87.9, 88.0, 88.1, 88.2, 88.3, 88.4, 88.5, 88.6, 88.7, 88.8, 88.9, 89.0, 89.1, 89.2, 89.3, 89.4, 89.5, 89.6, 89.7, 89.8, 89.9, 90.0, 90.1, 90.2, 90.3, 90.4, 90.5, 90.6, 90.7, 90.8, 90.9, 91.0, 91.1, 91.2, 91.3, 91.4, 91.5, 91.6, 91.7, 91.8, 91.9, 92.0, 92.1, 92.2, 92.3, 92.4, 92.5, 92.6, 92.7, 92.8, 92.9, 93.0, 93.1, 93.2, 93.3, 93.4, 93.5, 93.6, 93.7, 93.8, 93.9, 94.0, 94.1, 94.2, 94.3, 94.4, 94.5, 94.6, 94.7, 94.8, 94.9, 95.0, 95.1, 95.2, 95.3, 95.4, 95.5, 95.6, 95.7, 95.8, 95.9, 96.0, 96.1, 96.2, 96.3, 96.4, 96.5, 96.6, 96.7, 96.8, 96.9, 97.0, 97.1, 97.2, 97.3, 97.4, 97.5, 97.6, 97.7, 97.8, 97.9, 98.0, 98.1, 98.2, 98.3, 98.4, 98.5, 98.6, 98.7, 98.8, 98.9, 99.0, 99.1, 99.2, 99.3, 99.4, 99.5, 99.6, 99.7, 99.8, 99.9, 100.0]

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[7] 3D/4D

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

1358 K16 Via Belvedere Clearte

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

110 Organic Matters Direct, Inc. Important for Soil and Plants
Sommaire Important Pour Sol et Plantes

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CW+CFM+F

[5] Compound Imaging (MView)

N: Naveston In Freebedry Electronic of Pri-Alidded under Appenaux E
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IT3D/4D

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

K18-013 probe is already cleared via K18-013.doc

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

[1] SCHEMATIC STRUCTURES BY BRANCH, "LAST", "FIRST", AND "TEST" VARIABLES

Organization Structure: Branch, Last, First, Test

Cardiac Adult and Pediatric :

[13] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MicroView)

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

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Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Cardiac

Small Organs [1]
Neonatal Cephalic
Adult Cephalic

IL 4-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

Other (Urological)
The IL 4-13 probe is already cleared via K16135

P: 5 P: 5

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d d

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d d

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Laparoscopic
Musculo-skeletal Convention

Musculo-skeletal Superficial

P: 5

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Transrectal
Transvaginal
Transvaginal
Intravasinal
Intravascruitar
Peripheral
Peripheral Vascular

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LLC Schematic Structure, Materials, and Test Protocols

LLC Schematic Structure (Brace, Hinge, and Test Articles)
Materials
Test Protocols

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

[6] Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and

Visualization of the Motor Vehicular Environment
F1/3D/4D

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

PROBLEMS CURRENTLY COVERED VIA K1635

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

[1] Scherer, D., Bridwell, R., and Turk, G. "Example-Based Procedural Placement of Detail on Surfaces". In ACM Transactions on Graphics (TOG), 2012, 31, 4, 1-10.

2] Cardiac is Adult and Pediatric :

[13] Musculo Skeletal - Nerve Block

Combined modes are: A+B; A+N; B+N; A+B+N

[5] Compound Imaging (MVIEW)

[/2/3D/4D

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

K163528 probe is already cleared via K163528

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

Small Organochlorines Breast, Thyroid, Brain and Testicles
Cardiac is Adult and Pediatric

[13] Musculo Skeletal - Nerve Block

R.V. DI. an

4] Combined modes are: B+M+PV
CW+CFM+

Compound Imaging (NView)
Includes septum (C.M.I.S.)

[1] 3D/4D

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

SL2325
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

REVISED MODE IS THE OPTION THAT IS CURRENTLY OPEN FOR DISCUSSION.

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

Scientific and Technical Advances

11. Studies on Breast Thyroid Interactions

Organochlorine Pesticides and Breast Cancer: A Review

Small [E]

[2] Cardiac is Adult and Pediatric

[3]. Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-View)

N New Middeston, Fireviews Previous Price. Bidded under Appendas E
(3) Musicult end Personal Production March Manager Services
(3) Musicult and Proporto Cover March Productio

7T/3D/4D

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

AC2541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

The probe is already cleared via K16135

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

U.S. Special Operations Branch, Tropical and Pesticides
[E]

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

Bio. R.M. DUARTE

Combined modes are: B+M+PW+CW+CFM+P

[b] Compound Imaging (MNVIEW)
(12) Includes volume rendering (ICST) in addition to surface rendering.

N New Jindeshow Privated on Pri-Airaded under Appenda B
31 Musicula Shault Shares Brand.
23 Musium e Mault Parts March Production Maria Marian Andreamand
18 Comments and Pro

[7] 3D/4D

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

вм

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

CONSIDERATIONS FOR ADOPTING AGILE IS SIMILAR TO ADOPTING ANY NEW TECHNOLOGY. SOME OF THE PROBLEMS ARE:

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

NATIONAL INSTITUTES OF HEALTH
Solicitation Number: RFQ-NHLBI-DBBS-2024-02
Title: "Restricted Competition for the NHLBI Biorepository, Sample Processing, and Analysis (BioPSA) Resource and Repository"

Cardiac is Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

CONTAINS NOCS AND B. SP. CH. CHEM

Compound imaging (LMVIEW)

Multi-angle (S, M, L)
Spatial (S, M, L)

N New Middeston, Fireviews Previous Price. Bidded under Appendas E
Bij Musicult And Port Production Production March March March March March Manager Manager
Ball Comments of

[7] 3D/4D

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

ARE IS CURRENTLY CLOSED. PLEASE VISIT K16.CC/135

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

SCHEMERS WEST BRANCH, INC.

Thyroid Support and Rest
Prostate Plus
Brain Boost
Organ Support
Small Intesticles

2] Cardiac is Adult and Pediatric :

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

Now Madesson Art Fevel Bank Character Production Brander E
Bi Museum Artes Basic Brander Production March Andres Architection Andre
Bio Museum and Property Provided on Pro

[12] 3D/4D

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

вм

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

THIS REPORT IS BASED ON DATA CURRENT AS OF 11/15/2023. DATA IS SUBJECT TO CHANGE VIA REVISIONS.

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

Small Organic Molecules: Broad and Pesticides
[1]

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

+) Combined modes are: B+M+PV
CW+CFM+

[b] Compound Imaging (MVIEW)
(c) 1, 1/2, 1/4, 1/8, 1/16 ms, etc.

[7] 3D/4D

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

ARE 15 ACRES GENERALLY OPEN SPACE? YES, BUT THERE ARE EXCEPTIONS.

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

US Small Business Administration
SURETY BOND GUARANTEE PROGRAM
Information for Small and Emerging Contractors

[[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

I.V. R/L 500 ml stat

CONSIDERED SEC, R.P.T., M.P.C.H., I.A.H.

[5] Compound Imaging (Mview)
[6] Ingludes controot (CTI) in

[7] 3D/4D

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

RESOLUTION: HIGHLY ORGANIZED, WELL-STRUCTURED, CLEARLY PRESENTED, EASY TO UNDERSTAND, WELL-WRITTEN

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

Small Organic Molecules Include Sugars, Fatty Acids, Amino Acids, and Nucleotides

Cardiac is Adult and Pediatric
Cardiac is Adult, Pediatric

[3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CW+CFM+F

[15] Compound Imaging (Mew)

[7] 3D/4D

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

RESPECT BROKERS ALREADY OPERATING WITH CLIENTS.

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

SMALL OPTIONS INCLUDE: Tomatoes, Broccoli, Cauliflower, Spinach, and Potatoes

[[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

BMC Anesthesiology 2011, 11:14 http://www.biomedcentral.com/1471-2253/11/14

Combined modes are: B+M+PW+CW+CFM+

[5] Compound Imaging (MView)

[7] 3D/4D

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

SCHOTT® BOROFLOAT® 33
Borosilicate Glass
Ready for new ideas

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

Small Organics Processes Branch, Biopesticides and Pollution Prevention Division

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+
W+CW+CFM+F

New Malleation in Previews Channel of Prid Einded under Appender B
23 Murdina Malay Previous March Stades under Appendes B
23 Marcula Prace Brander Proved Andres Productio

[7] 3D/4D

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

K1635135
Via Redacted
Clearly Cleaners
Property Address

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

[1] SCHUMANN, STRUMAS, BRENNAN, and TROTTIER: Sources and Restrictive Practices

[2] Cardiacs Adult and Pediatric

[13 Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MewView)

N New Hillening Pires Business of PDA. Bidded under Appendix B
(3) Murdina Balaika Maria Maria Maria Maria Maria Marian Marian Marian Marina Hora
(3) Comment masu (2017) Mark

[I7/3D/4D]

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

VIA REDONDA IS PROUD TO ANNOUNCE VIA K1635

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

US Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

+) Combined modes are: B+M+P+
CW+CFM+F

[5] Compound Imaging (MView)

N: Nav Maleston I I Previews Cases in Prav Sindes under Appenax E
Si Murdina Malul Services Maria Maria Maria Maria Maria Marian Marian Marina Harina
Bal Combination Masti

[1] 3D/4D

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

saote SpA 6425 510(k)
Esaote 6425 Ultrasound System 510

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

SPORTS AND ENTERTAINMENT VIA BLOGS AND SOCIAL MEDIA PLATFORMS ARE INCREASINGLY CLEARLY DEFINED AS ESSENTIAL

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

[1] SCHMIDT-ROGERS INDICES BASED ON "LAST" BRENT CRUDE OIL PRICES

Cardiac, Adult, and Pediatric

[3] Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CW+CFM+F

[5] Compound Imaging (Myview Imaging, Mview, m)

N New Madesham Pirter Business of PDA: BiAdded under Appendas B
3) Musicult end Personal Production March Manager Armanda B
31 Museum en artista Mark Proveder Price Archives

[F13D/4D

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

SP2430

Other (Urological)
The SP2430 probe is already cleared via K161357

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

First Breeches
and Other Stories from Iran, inc.

HL Cardiacs Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Images : MView

11 New lindestion in Previously Craned by PDA: Bridded under Appendix E
12 Prediker in Arabi and Personal Pro
13 Posted on Archives Merce Brown Pro
10 Posted in Maria Briti

visualization of the left ventricle.

1713D4D

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

ote SpA 6425 510(k)
Esaote 6425 Ultrasound System 510

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

the SP2/042 probe is already cleared via K161335

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

L.L.C. Summers, Byerly, Poston & Furr, P.A.
Attorneys and Counselors
Specialized Trial and Appellate Services

[2] Cardiac is Adult and Pediatric

[13] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

11 Service Arabeahany - Derrestourly PDAT Bender Appendix Printer
11 Marculos Multi - Increations
12 Museum e Museum - Preve Brown PD Microsoft Provincial opacification a

F1/3D/4D

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

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

Clinical Application	PWD	Mode of Operations
		ColorDoppler	AmplitudeDoppler(PD)	Combined[4]
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
Musculo-skeletal Superficial [3]
Other (Urological)

THIS SPONSORED SECTION IS BROUGHT TO YOU BY K1621353 VIA KKR161353

This profile is already cleared via KKR161353

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

[1] SCHIRMER, MOSES, PERL & HUGHES
Attorneys at Law
100 Park Avenue, 17th Floor
New York, NY 10017

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

(1) ﺃﺧﺮ ﺍﻟﻤﺎﻧﻴﻮﻧﻴﺴﻴﺎﻥ ﺍﻟﻤﺠﺎﻧﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺑﻤﻨﻄﻘﺔ

Visualization of the left ventricular endocardium

(21/25)/VR

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

Traditional 510(k) Summary

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

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 allison.scott@navigant.com

Date:

September 28, 2016

807.92(a)(2)

Trade Name: Model 6425 Ultrasound System
Common Name: Ultrasound Imaging System
Classification Name(s): Ultrasonic pulse Doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560 Diagnostic ultrasonic transducer 892.1570
Classification Number: 90IYN, 90IYO, 90ITX

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

807.92(a)(3)

Predicate Device(s)

Predicate	510(k)	Device	Owner
Primary	K161359	6400 - MyLabSeven	Esaote S.p.A.
Reference	K141486	6420 - MyLabSix	Esaote Europe B.V.

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

Device Description

Model 6425 is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. Model 6425 is also equipped with a height adjustable/rotating keyboard.

A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.

Model 6425 can drive phased (PA), convex array (CA), linear array (LA) probes, Doppler probes and Volumetric probes.

Model 6425 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The model 6400 is already cleared via K161359. The model 6420 is already cleared via K141486.

The purpose of this submission is to introduce a new ultrasound system, model 6425. The system is based on Esaote S.p.A., model 6400, previously cleared via K161359 and Esaote Europe, model 6420, previously cleared via K141486.

No new applications are introduced.
No new probes are added.
No additional software capabilities added.

Model 6425, defined herein, combine the cleared features of Esaote S.p.A. model 6400 model and Esaote Europe model 6420.

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

The 6425 model is a combination of 6420 model previously cleared version via K141486 and 6400 model, previously cleared version via K161359.

The Model 6425 is manufactured under an ISO 9001 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use(s)

Esaote's Model 6425 ultrasound system 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. The 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.

807.92(a)(6)

Technological Characteristics

Esaote's Model 6425 employs the same fundamental technological characteristics as its predicate devices. The Model 6425 is substantially equivalent to Esaote's Model 6400 already cleared via K161359 and Esaote Europe's Model 6420 already cleared via K141486.

Clinical uses for which the Model 6425 is designed are equivalent to those of Model 6400, already cleared via K161359.
. The Model 6425, Model 6400 and Model 6420 are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
. The Model 6425, Model 6400 and Model 6420 provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
The Model 6425, Model 6400 and Model 6420 provide a similar measurements and analysis package, with equal accuracy and precision.
The Model 6425, Model 6400 and Model 6420 have digital storage capabilities, including Network connectivity.
The Model 6425 image modes are available on other FDA cleared ultrasound systems, for instance Model 6400 and Model 6420.

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

807.92(b)(1)

Summary of Non-Clinical Tests

The Model 6425 has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and have been found to conform to the following medical device safety standards.

IEC 60601-1 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.
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

The Model 6425 is 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.

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។

LLC Schematic Structure, Materials, and Test Protocols

Scientific and Technical Advances

11. Studies on Breast Thyroid Interactions

Organochlorine Pesticides and Breast Cancer: A Review

Small [E]

SCHEMERS WEST BRANCH, INC.

Small Organics Processes Branch, Biopesticides and Pollution Prevention Division

SP2430

Traditional 510(k) Summary

Submitter Information

807.92(a)(3)

Predicate Device(s)

Device Description

807.92(a)(5)

Intended Use(s)

807.92(a)(6)

Technological Characteristics

807.92(b)(1)

Summary of Non-Clinical Tests

807.92(b)(2)

Summary of Clinical Tests

807.92(b)(3)

Conclusion

§ 892.1550 Ultrasonic pulsed doppler imaging system.