Predicate Devices

K133905, K142008, K061961, K093466, K134016

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes and a software option for image fusion, but there is no mention of AI or ML capabilities, training data, or performance metrics typically associated with such technologies.

Therapeutic

No
The device is described as a "diagnostic general ultrasound system" and is primarily used for imaging and guidance of procedures like biopsy, not for direct treatment of medical conditions.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the systems are "used to perform diagnostic general ultrasound studies." Additionally, the "Device Description" section reiterates that both models are "mainframe ultrasound systems used to perform diagnostic general ultrasound studies."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the 6200 and 6250 models are "mainframe ultrasound systems," which are hardware devices. The Virtual Navigator is described as a "software option" for these hardware systems, indicating it is a component of a larger hardware-based medical device, not a standalone software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs analyze samples taken from the human body. The intended use and device description clearly state that the Esaote Model 6200 and 6250 systems are ultrasound systems used to perform diagnostic imaging on the human body. They acquire images directly from the patient.
The Virtual Navigator software uses existing imaging modalities (CT, MR, US, PET) and ultrasound. These are all in vivo imaging techniques, meaning they are performed on a living organism. While the Virtual Navigator uses information from these modalities, it's not analyzing a biological sample in vitro (outside the body).

The device is a medical imaging system used for diagnostic purposes in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needler 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, 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, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

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

IYN, IYO, ITX

Device Description

Both 6200 and 6250 models 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, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 are equipped with an 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.

6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 systems with new capabilities, listed below:

Management of Pulsed Wave (PW) Doppler probe on both 6200 and 6250 Upgrades.
Management of Quality Arterial Stiffness (QAS) on both 6200 and 6250 Upgrades.
Addition of Abdominal, Intraoperative abdominal, Transvaginal, Urology applications in Elastosonography analysis on both 6200 and 6250 Upgrades.
Management of Elastosonography measures on both 6200 and 6250 Upgrades.
Management of STIC (Spatio-Temporal Imaging Correlation) with volumetric Probes on both 6200 and 6250 Upgrades.
Management of Intraoperative (Neuro) application on both 6200 and 6250 Upgrades.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133905, K142008, K061961, K093466, K134016

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K142008, K134016, K061961, K093466

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

May 4, 2016

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

Re: K153277

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: April 13, 2016 Received: April 18, 2016

Dear Ms. Scott:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

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

2

Indications for Use

510(k) Number (if known) K153277

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. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needler 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, 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, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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6200

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

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	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; N: 8
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7; N: 8
Intraoperative (Abdominal)	N	N	N	N	N	N	N	N	N	N: 5, 6, 7
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, 8
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
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 (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, 8
Transesophageal (Non Cardiac)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7; N: 8
Transrectal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transvaginal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
Transurethral	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8
Intravascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7, 8
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5, 6, 7; N: 8
Laparoscopic	P	P	P	P	P	P	P	P	P	P: 5, 6, 7
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, 8
Other (Urological)	P	P	P	P	P	P	P	P	P	P: 5, 6, 7; N: 8

రు d by F siy cir

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

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

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

Previously cleared via K100931
K133905

5

6250

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: 5, 6, 7
Fetal	P	P	P	P	P	P	P		P	P: 5, 6, 7; N: 8
Abdominal	P	P	P	P	P	P	P	P	P	P: 5, 6, 7; N: 8
Intraoperative (Abdominal)	P	P	P	P	P	P	P		P	N: 5, 6, 7
Intraoperative Neurological	N	N	N	N	N	N	N		N	N: 5, 6, 7
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, 8
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: 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: 5, 6, 7
Transrectal	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8
Transvaginal	P	P	P	P	P	P	P		P	P: 5, 6, 7; N: 8
Transurethral	P	P	P	P	P	P	P		P	P: 5, 6, 7
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
Laparoscopic	P	P	P	P	P	P	P		P	P: 5, 6, 7, 8
Musculo-skeletal Conventional	P	P	P	P	P	P	P		P	P: 5, 6, 7; N: 8
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Other (Urological)	P	P	P	P	P	P	P		P	P: 5, 6, 7; N: 8
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
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7
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	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
Intravascular
Peripheral Vascular	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: 5, 6, 7
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5, 6, 7
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:	Mode of Operations
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	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
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7
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, 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	P: 5, 6, 7
V: New indication: P: Previously cleared by FDA: E:Added under Appendix
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	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	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
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		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
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]	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
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	P: 5, 6, 7
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	P	P		P	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
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]	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
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	P: 5, 6, 7
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: 5, 6, 7
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7; N: 8
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7
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]	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
Laparoscopic
Musculo-skeletal Conventional [3]	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	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
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5, 6, 7
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, 6, 7
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)	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: 5, 6, 7
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 6, 7
Intraoperative (Abdominal)	P	P	P		P	P	P		P	P: 5, 6, 7
Intraoperative Neurological	P	P	P		P	P	P		P	P: 5, 6, 7
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	P	P	P		P	P	P		P	P: 5, 6, 7
Adult Cephalic	P	P	P		P	P	P		P	P: 5, 6, 7
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
Laparoscopic
Musculo-skeletal Conventional [3]	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	P: 5, 6, 7

text
Pharmacy: Eddy Pharmacy
Script#: 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

[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

Musculo Skeletal - Nerve Block

[5] Compound Imaging (Mview)

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

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

Previously cleared via K103152,
K133905

6

CA123 (6200 and 6250 systems)

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

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

[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+CW+CFM+PD

5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

7

CA421 (6250 system only)

Intended use: Diagnostic ultrasound im

Intended use: Diagnostic ultrasound imag

or fluid flow

: 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 (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

13

CA631 (6200 and 6250 systems)

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

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

(1) Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

14

Other (specif P: 5, 6, 7 P: 5, 6, 7 N: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 P: 5, 6, 7 Harmonic

maging (TEI) в d d
d n P d d d P Color Velocity
Mapping (TVM) Combined
[4] :3123 (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: d P n b d b P d d d Amplitude
Doppler
(PD) P d P N പ b d d ﮨﮯ d Color
Doppler d P N d b d d P ﮩﻢ P CWD PWD d P b P N d ﮨﮯ പ d മ M d P n P d d ﮨﻢ d b P B d P N പ P d b P P d Iusculo-skeletal Superficial [3] 'ransesophageal (Cardiac)
Transesophageal (Non Cardiac) Laparoscopic
Musculo-skeletal Conventional ntraoperative (Abdominal)
ntraoperative Neurological Clinical Application Intravascular
Peripheral Vascular Neonatal Cephalic
Adult Cephalic Other (Urological) 'mall Organs [1] ransvaginal
Transurethral )phthalmic ransrectal bdominal ardiac [2] ediatric Fetal โร

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

[1] Small Organs includes Breast, Thyroid and Testici
[2] Cardiac is Adult and Pediatric
[3] Cardiac is Adult and Pediatric
[4] Combined modes are: B+M+PW+CW+CW+CFM+PD

Compound Imaging (Mvie

[6] 3D
[7] CMM
[8] Elastosonography

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

reviously cleared via k1420

ription Use Only Per 21 CFR 801 Part D C
CDRH, Office of In Vitro Diagnostics (

15

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

SI2C41 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of

ppe sly cleared by Fi

[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+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

To be cleared with this submission

16

Prescription Use Only Per 21 CFR 801 Part D Concurrence of

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

To be cleared with this
submission

[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 (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

SC3121 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

CDRH, Office of In Vitro Diagnostics (OIVD)

17

LA332 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

der Appe by FDA; ed

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

18

LA435 (6200 and 6250 systems)

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

New indication; P. Previously cleared by FDA; E:A ded under Appendix F

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14207

19

LA522 (6200 and 6250 systems)

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

Prev: Appendix: DHCP by DHCP: ClearOS

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

20

LA523 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K142008

21

LA532 (6250 systems only)

Intended use: Diagnostic ultrasound imag

ic r onalı, fluid flow iina

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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

22

LA533 (6200 and 6250 systems)

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

Previca

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

23

.A923 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

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

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

24

SL3116 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

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

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

25

PA023 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fo

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

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

26

PA122 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

nder Appe ಸಿ: ಕ sly cleared by FDA; on; P: Prev

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390s

27

PA230 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

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

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

28

PA240 (6200 and 6250 systems)

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

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

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

29

BC431 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

nder Appe ared by FDA; sly n; P: Prev

[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+CFM+PD

[5] Compound Imaging (Mview)

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

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

Previously cleared via K142008

30

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	P	P	P		P	P		P	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
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]	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
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	P: 5, 6, 7
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Clinical Application
Ophthalmic	P	P	P		P	P	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
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; E: 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 [3]	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	P: 5, 6, 7
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
Mode of Operations
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic	P
Fetal		P	P		P	P	P		P	P: 5, 6, 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: 5, 6, 7
Transvaginal			P		P	P	P		P	P: 5, 6, 7
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)		P	P		P	P	P		P	P: 5, 6, 7
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:						Mode of Operations
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(PD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P	P: 5, 6, 7
Fetal	E	E	E		E	E	E		E	E: 5, 6, 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, 6, 7; E: 8
Transvaginal	P	P	P		P	P	P		P	P: 5, 6, 7
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)	P		P		P	P	P		P	P: 5, 6, 7; N:8

Indica

[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+CFM+PD

[5] Compound Imaging (Mview)

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

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

Previously cleared via k14200a

31

433 (6200 and 6250 systems)
nded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

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

[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+CFM+PD

5] Compound Imaging (Mview

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

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

Previously cleared via k13390

32

BE1123 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

bb

[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+CFM+PD

[3]

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

[5] Compound Imaging (Mview)

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

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

Previously cleared via k14200

33

C123 (6200 and 6250 system

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

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+CFM+PD

5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390

34

EC1123 (6200 and 6250 systems)

Intended use: Diagnostic ultrasound imaging or f

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color	Mode of Operations:
Combined	Color Velocity
Amplitude

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	P	P	P		P	P	P		P	P: 5, 6, 7
Fetal	P	P	P		P	P	P		P	P: 5, 6, 7
Abdominal	P	P	P		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, 8
P: 5, 6, 7; N: 8
Transvaginal	P	P	P		P	P	P		P
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5, 6, 7
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5, 6, 7; N:8

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

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

35

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(PD) | Combined
[4] | Color Velocity
Mapping (TVM) | Har
Imagi |
|----------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|--------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |

TEE022 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

Clinical Application	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	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
Musculo-skeletal Superficial [3]
Other (Urological)

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

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

36

TEE132 (6200 and 6250 systems

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

04 osystems)
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as

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

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390s

37

IOE323 (6200 and 6250 systems)
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as fol

ider Appe by FDA; ed

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14200a

38

T332 (6200 and 6250 systems)
ded use: Diagnostic ultrasound imaging or fluid flow analysis of human body as for

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

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14200

39

T342 (6200 and 6250 systems)
ded use: Diagnostic ultrasound imaging or fluid flow a

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

[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+CFM+PD

[5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14200

40

LP323 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as foll

der Appe by FDA; ed

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14200a

41

TRT33 (6200 and 6250 systems)
tended use: Diagnostic ultrasound imaging or fluid flow a

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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k14200a

42

fluid flow 2CW (6200 and 6250 systems)

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

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatrio
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

5] Compound Imaging (Mview

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13390s

43

or fluid flow 5CW (6200 and 6250 systems)

Intended use: Diagnostic ultrasound imaging

: 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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

44

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

New indication; P: Previously cleared by FDA; E:AC
ler 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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via K133905

45

S2MPW (6200 and 6250 systems)

Intended use: Diagnostic ultrasound imaging or fl

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

[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+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D
[7] CMM
[8] Elastosonography

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

Previously cleared via k13246

46

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 Siffredi 17
Genova, Italy 16153
Contact Person:	Allison Scott
317.228.8719
allison.scott@navigant.com
Date:	November 10, 2015
807.92(a)(2)
	Devices
Common Name:	Ultrasound Imaging System
Trade Name:	6200 Ultrasound System
6250 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550
Ultrasound Pulse Echo Imaging System 892.1560
Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

807.92(a)(3)

Predicate Device(s)

Predicate	Device	Owner	510(k)
Primary	6200/6250	Esaote	K133905
Reference	6400	Esaote	K142008
Reference	Arietta 70	Hitachi Aloka	K134016
Reference	ART.LAB	Esaote Europe	K061961
Reference	Preirus	Hitachi Aloka	K093466

47

510(k) Submission 6200 and 6250 Upgrade Esaote, S.p.A.

807.92(a)(4)

Device Description

Both 6200 and 6250 models 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, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Elastosonography. Both 6200 and 6250 are equipped with an 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.

6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 systems with new capabilities, listed below:

1. Management of Pulsed Wave (PW) Doppler probe on both 6200 and 6250 Upgrades.
1. Management of Quality Arterial Stiffness (QAS) on both 6200 and 6250 Upgrades.
1. Addition of Abdominal, Intraoperative abdominal, Transvaginal, Urology applications in Elastosonography analysis on both 6200 and 6250 Upgrades.
1. Management of Elastosonography measures on both 6200 and 6250 Upgrades.
1. Management of STIC (Spatio-Temporal Imaging Correlation) with volumetric Probes on both 6200 and 6250 Upgrades.
1. Management of Intraoperative (Neuro) application on both 6200 and 6250 Upgrades.

The 6200 and 6250 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

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,

48

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, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, 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 should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

807.92(a)(6)

Technological Characteristics

The 6200 and 6250 Upgrades employ the same fundamental technological characteristics as their predicate devices.

The 6200 Upgrade model is substantially equivalent to Esaote 6200 model cleared via K133905, Esaote 6400 cleared via K142008, Esaote Europ ART.LAB cleared via K061961, Hitachi Preirus cleared via K093466, and Hitachi Aloka Arietta 70 cleared via K134016.

The 6250 Upgrade model is substantially equivalent to Esaote 6250 model cleared via K133905, Esaote 6400 cleared via K142008, Esaote Europ ART.LAB cleared via K061961, Hitachi Preirus cleared via K093466, and Hitachi Aloka Arietta 70 cleared via K134016.

Clinical uses for which Esaote 6200 and 6250 models have been cleared via 510(k) K133905 and are not changed by 6200 and 6250 Upgrades, to be cleared via this submission.
6200 and 6250 Upgrades for managing Pulsed Wave Doppler probe are equivalent to those of Esaote 6400 model, cleared via K142008.
6200 and 6250 Upgrades for managing Quality Artery Stiffness (QAS) are equivalent to eTracking feature of Hitachi Aloka Arietta 70 cleared via K134016 and Esaote ART.LAB software cleared via K061961.
6200 and 6250 Upgrades for managing Elastosonography in Abdominal, Intraoperative Abdominal, Transvaginal and Urology applications are equivalent to those of Hitachi Aloka Arietta 70 cleared via K134016 and Hitachi Preirus cleared via K093466.

49

6200 and 6250 Upgrades for managing Elastosonograpy measures is equivalent to those of Hitachi Aloka Arietta 70 cleared via K134016 and Hitachi Preirus cleared via K093466.
6200 and 6250 Upgrades for managing STIC with Volumetric Probes is equivalent to STIC feature of Hitachi Aloka Arietta 70 cleared via K134016.
6200 and 6250 Upgrades for managing Intraoperative (Neurological) application are equivalent to those of Hitachi Aloka Arietta 70 cleared via K134016.
. Esaote 6200 Upgrade, 6250 Upgrade, 6400, Hitachi Aloka Arietta 70 are designed to meet the IEC60601-1.
Esaote 6200 Upgrade, 6250 Upgrade, 6400, Hitachi Aloka Arietta 70 are designed to meet the . IEC60601-1 and IEC60601-2-37 safety requirements.
Esaote 6200 Upgrade, 6250 Upgrade, 6400, Hitachi Aloka Arietta 70 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

807.92(b)(1)

Summary of Non-Clinical Tests

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

IEC 60601-1
IEC 60601-1-2
IEC 6060 1-2-37
. NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. NEMA UD-2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

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