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.

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.

AI/ML Overview

This document describes the 510(k) premarket notification for the Esaote S.p.A. 6200 Ultrasound System and 6250 Ultrasound System. It outlines the intended use and technological characteristics of the devices and their upgrades, comparing them to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it describes "Substantial Equivalence" as the primary acceptance criterion. The device performance is deemed acceptable if it demonstrates substantial equivalence to legally marketed predicate devices for their intended uses and technological characteristics, and if it conforms to relevant safety and performance standards.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary of Equivalence Claims)
Substantial Equivalence to Predicate Devices for Intended Use: The device (6200 and 6250 Ultrasounds Systems and their upgrades) should perform diagnostic general ultrasound studies for listed clinical applications, including Cardiac, Peripheral Vascular, Abdominal, Fetal, Musculoskeletal, etc., as well as provide imaging for guidance of biopsy and needle placement. The Virtual Navigator software option should support radiological clinical ultrasound examinations using additional image information from a second modality.	- Esaote 6200 and 6250 models: Cleared via 510(k) K133905 for diagnostic general ultrasound studies across numerous clinical applications 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 Urologic. They also provide imaging for guidance of biopsy and needle placement. - Virtual Navigator software option: Intended to support radiological clinical ultrasound exams (first modality) and percutaneous procedures/surgical operations by providing additional image information from CT, MR, US, and PET. Can be used in Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular, and Transcranial applications for radiological examinations only. (The second modality image is not for standalone diagnostic use). - New functionalities (Upgrades): - Management of Pulsed Wave (PW) Doppler probe: Equivalent to Esaote 6400 (K142008). - Management of Quality Arterial Stiffness (QAS): Equivalent to eTracking feature of Hitachi Aloka Arietta 70 (K134016) and Esaote ART.LAB (K061961). - Addition of Abdominal, Intraoperative abdominal, Transvaginal, Urology applications in Elastosonography analysis: Equivalent to Hitachi Aloka Arietta 70 (K134016) and Hitachi Preirus (K093466). - Management of Elastosonography measures: Equivalent to Hitachi Aloka Arietta 70 (K134016) and Hitachi Preirus (K093466). - Management of STIC (Spatio-Temporal Imaging Correlation) with volumetric Probes: Equivalent to STIC feature of Hitachi Aloka Arietta 70 (K134016). - Management of Intraoperative (Neuro) application: Equivalent to Hitachi Aloka Arietta 70 (K134016).
Technological Equivalence to Predicate Devices: The device should employ the same fundamental technological characteristics as its predicate devices.	- Fundamental technological characteristics: The 6200 and 6250 Upgrades employ the same fundamental technological characteristics as their predicate devices (Esaote 6200/6250, Esaote 6400, Esaote ART.LAB, Hitachi Preirus, Hitachi Aloka Arietta 70). - Modes of operation: Both systems use B-Mode, TEI, M-Mode, MView, Doppler (PW and CW), Color Flow Mapping, Amplitude Doppler (AD), TVM, 3D and 4D, Elastosonography. - Safety Standards: Esaote 6200 Upgrade, 6250 Upgrade, 6400, Hitachi Aloka Arietta 70 are designed to meet IEC60601-1 and IEC60601-2-37 safety requirements. - Acoustic Output: Ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
Conformity to Medical Device Safety Standards: The device should conform to recognized medical device safety standards.	- Non-Clinical Tests: Evaluated for performance, acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electromagnetic, and mechanical safety. Found to conform to: - IEC 60601-1 - IEC 60601-1-2 - IEC 60601-2-37 - NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices) - NEMA UD-2 (Acoustic Output Measurement Standard)

2. Sample size used for the test set and the data provenance:
The document does not provide any details on a specific "test set" in the context of clinical performance data. The device's substantial equivalence is primarily based on technological comparisons to predicate devices and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set with corresponding ground truth established by experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a submission for an ultrasound system and its software options, not an AI-assisted diagnostic device that would typically undergo MRMC studies to evaluate reader performance improvement with AI. The Virtual Navigator software supports radiological clinical ultrasound but is explicitly stated as "not intended to be used as a standalone diagnostic image."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable for this type of device and software functionality as described. The Virtual Navigator is an aid to a radiological clinical ultrasound examination, implying human-in-the-loop use, but it does not perform standalone diagnostics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical performance study requiring a defined ground truth is mentioned. The submission focuses on demonstrating substantial equivalence based on technological characteristics and adherence to existing standards.

8. The sample size for the training set:
Not applicable, as no AI/machine learning model requiring a training set is explicitly described or evaluated in this regulatory document for establishing substantial equivalence. The document focuses on hardware (ultrasound systems) and software features (Virtual Navigator, QAS, Elastography, STIC) and their equivalence to previously cleared devices.

9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned.

Summary

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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.

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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) K153277

Device Name

6200 Ultrasound System and 6250 Ultrasound System

Indications for Use (Describe)

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

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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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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

or fluid flow

1: 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+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

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

CA430 (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+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

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

CA431 (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 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+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

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

5-2 R13 (6200 and 6250 systems)

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

: 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

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

CA541

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

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

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

Previously cleared via K133905

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

CA621 (6250 systems only)

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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SpA

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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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 VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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

[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, 8P: 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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarImagi
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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]									P
Transesophageal (Cardiac)		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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]				P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Intended 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
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	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic			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 17Genova, Italy 16153
Contact Person:	Allison Scott317.228.8719allison.scott@navigant.com
Date:	November 10, 2015
807.92(a)(2)
	Devices
Common Name:	Ultrasound Imaging System
Trade Name:	6200 Ultrasound System6250 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550Ultrasound Pulse Echo Imaging System 892.1560Transducer, 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

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.

{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 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.

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.