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K Number
K133905
Device Name
6200 / 6250 ULTRASOUND SYSTEM
Manufacturer
ESAOTE S.P.A.
Date Cleared
2014-04-15

(113 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). 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 or US). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality. 6200 models including Virtual Navigator software option have been cleared by k100931; 6250 models including Virtual Navigator software option have been cleared by k103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by k081386. The purpose of this submission is to introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabilities. 6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with other new software capabilities related to the Virtual Navigator software option and listed below: - Navigation Software new user interface . - Tracking System new Ascension tracking module managing also needle and motion . sensors - Second Modality Data Acquisition multi dataset management (MRI, PET, CT, US via . Dicom - US including acquisition and navigation) - New Indications: Gynecological, Obstetrics, Pediatric, Small Organs, Transcranial . - Registration Techniques added one point registration . - Target Definition introduced intelligent positioning . - Planning updated needle table . - 3D Panoramic ● The 6200 and 6250 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.
More Information

K100931, K103152, K081386, K123564

GE Logiq E9 with Volume Navigation K123564, Esaote 6100 and 6150 models (K081386), General Electric 3D/4D mode (082185)

No
The document describes an ultrasound system with a software option for image fusion and navigation, but there is no mention of AI or ML in the intended use, device description, or the specific sections for mentioning AI/ML. The "intelligent positioning" mentioned under "Planning" is not explicitly defined as an AI/ML technique in this context.

No
The device is described as an ultrasound system used to perform diagnostic general ultrasound studies and provide imaging for guidance of biopsy and needle placement. Its primary function is diagnostic imaging and guidance, not active treatment or therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states that the mainframe ultrasound systems (Model 6200 and 6250) are "used to perform diagnostic general ultrasound studies." While the Virtual Navigator option provides additional information from other modalities, it's clearly stated that the main ultrasound modalities are for diagnostic purposes.

No

The device is described as a software option for mainframe ultrasound systems (6200 and 6250) and includes a "Tracking System new Ascension tracking module managing also needle and motion sensors," indicating the inclusion of hardware components beyond just software.

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

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is an ultrasound system used for imaging the human body directly, not for analyzing samples taken from the body (like blood, urine, tissue biopsies after they are removed).
  • The device's function is diagnostic imaging and procedural guidance. It provides visual information about internal structures and assists in procedures like biopsies and needle placement. This is distinct from the analytical and diagnostic processes performed on in vitro samples.

The device is a medical imaging system used in vivo (within the living body), not in vitro (in glass or outside the living body).

N/A

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, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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)

901YN, 901YO, 901TX

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, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). 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 or US). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

6200 models including Virtual Navigator software option have been cleared by K100931; 6250 models including Virtual Navigator software option have been cleared by K103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by K081386.

The purpose of this submission is to introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabilities. 6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with other new software capabilities related to the Virtual Navigator software option and listed below:

  • Navigation Software new user interface .
  • Tracking System new Ascension tracking module managing also needle and motion . sensors
  • Second Modality Data Acquisition multi dataset management (MRI, PET, CT, US via . Dicom - US including acquisition and navigation)
  • New Indications: Gynecological, Obstetrics, Pediatric, Small Organs, Transcranial .
  • Registration Techniques added one point registration .
  • Target Definition introduced intelligent positioning .
  • Planning updated needle table .
  • 3D Panoramic ●

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound, CT, MR, PET

Anatomical Site

Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic, Urologic, Gynecological, Transcranial (for radiological examinations only), Breast, Thyroid, Testicles

Indicated Patient Age Range

Adult, Pediatric, Neonatal (Cephalic only)

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical tests were performed.

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

Not Found

Predicate Device(s)

K100931, K103152, K081386, K123564

Reference Device(s)

GE Logiq E9 with Volume Navigation K123564, Esaote 6100 and 6150 models (K081386), General Electric 3D/4D mode (082185)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

K133905

APR 1 5 2014

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 58 Genova, Italy 16153

Contact Person:

Allison Scott 317.569.9500 x106 ascott@ansongroup.com

Date:

March 17, 2014

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

901YN, 901YO, 901TX Classification Number:

807.92(a)(3)

Predicate Device(s)
Owner
DeviceOwner510(k)
6200EsaoteK100931
6250EsaoteK103152
Virtual Navigator SoftwareEsaoteK081386
GE Logiq E9 with Volume
NavigationGEK123564

1

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, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). 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 or US). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

6200 models including Virtual Navigator software option have been cleared by K100931; 6250 models including Virtual Navigator software option have been cleared by K103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by K081386.

The purpose of this submission is to introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabilities. 6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with other new software capabilities related to the Virtual Navigator software option and listed below:

  • Navigation Software new user interface .
  • Tracking System new Ascension tracking module managing also needle and motion . sensors
  • Second Modality Data Acquisition multi dataset management (MRI, PET, CT, US via . Dicom - US including acquisition and navigation)
  • New Indications: Gynecological, Obstetrics, Pediatric, Small Organs, Transcranial .
  • Registration Techniques added one point registration .
  • Target Definition introduced intelligent positioning .
  • Planning updated needle table .
  • 3D Panoramic ●

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

2

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), Laparoscopic and Other: Urologic. The 6200 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), 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 predicated devices. The 6200 Upgrade model is substantially equivalent to Esaote 6200 model cleared by FDA via K100931. The 6250 Upgrade model is substantially equivalent to Esaote 6250 model cleared by FDA via K103152. The Virtual Navigator software is substantially equivalent to prior clearances in K100931, K103152 and K081386. Additional features of the Virtual Navigator are substantially equivalent to the GE Volume Navigation as cleared on the GE Logiq E9 via K123564.

3

:

  • Clinical uses for which both 6200 and 6250 are designed are not changed by the 6200 and 6250 Upgrades, to be cleared with this submission.
  • Clinical uses for which both 6200 and 6250 Upgrades are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote 6250 model, cleared via K103152.
  • · Clinical uses for which Virtual Navigator is designed are the same of the 6200 and 6250 systems.
  • Clinical uses for which Virtual Navigator Upgrades are equivalent to those of General Electric Volume Navigation on the Logiq E9, cleared via K123564.
  • Esaote 6200, 6250 and General Electric (GE) Logiq E9 ultrasound systems are equipped with a . software option designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR or US). Virtual Navigator was originally FDA cleared via K081386 with Esaote 6100 and 6150 models, and was subsequently cleared for use with the Esaote 6200 and 6250 models via K100931 and K103152, respectively. The GE Volume Navigation has been cleared via K123564.
  • Esaote 6200, 6250 and General Electric Logiq E9 ultrasound systems are able to acquire . volumetric dataset using motorized probe. Esaote 3D/4D mode with motorized probes has been FDA cleared via K100931 for 6200 model and via K103152 for 6250 model, General Electric 3D/4D mode has been FDA cleared via 082185.
  • Esaote 6200, 6250 and General Electric Logiq E9 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
  • Esaote 6200, 6250 and General Electric Logiq E9 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 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 .
  • . ISO 14971
  • ISO 62304 .

4

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.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Public Health Service

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

April 15, 2014

ESAOTE S.P.A. C/O ALLISON SCOTT NAVIGANT CONSULTING, INC. 9001 WESLEYAN ROAD, SUITE 200 INDIANAPOLIS, IN 46268

Re: K133905

Trade/Device Name: 6200 Ultrasound System, 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: March 17, 2014 Received: March 18, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the 6200 and 6250 Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

CA123CA421CA430CA431
C5-2 R13CA541CA621CA631
SC3123LA332LA435LA522
LA523LA532LA533LA923
SL3116PA023PA122PA230
PA240BC431BC441BC433
BE1123EC123EC1123TEE022
TEE132IOE323IOT332IOT342
LP323TRT332CW5CW
HFCW

6

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

FDA

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

7

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510{k) Number (if known) K133905

Device Name

6200 and 6250 Ultrasound Systems

Indications for Use (Describe)

Esacte's Model 6200 is a mainframe ultrasound system used to perform diagnosic general ultrasound studies including Cardiac, Transcsophageal Cardiac, Peripheral Vascular, Neonatic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superlicial), Abdominal, Fetal, Transrecal, Pediatic, Intraoperative (Abdominal), 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.

Essote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesorbagal Cardiac. Peripheral Vascular. Neonalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Feal, Transvaginal, Transceal, Pediatric, Introoperative (Abdominal), 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 is intended to support a radiological clinical ultrasound cramination (first modality) and follow perculares 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 norphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculo-skeletal, Obsterics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological cxaminations only.

The second modelity image is not intended to be used as standalone diagnostic image since it represents information of a palient that could not be congreent 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 not be used around life supporting equipment.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

8

Mode of Operations
Clinical ApplicationBMFWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)PPPPPPPP
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult CephalicPPPPPPPP
Cardiac [2]PPPPPPPPP (8)
Transesophageal (Cardiac)PPPPPPPPP
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
LaparoscopicPPPPPPPP
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

.

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+CW+CFM+PD

|5| Compound Imaging (Mview)

|6| 3D/4D |7] СММ

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

Previously cleared via K100931

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

6200

9

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)PPPPPPPP
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult CephalicPPPPPPPP
Cardiac [2]PPPPPPPPP (8)
Transesophageal (Cardiac)PPPPPPPPP
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
LaparoscopicPPPPPPPP
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

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

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/4D (7) CMM

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

Previously cleared via K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

6250

10

CA123 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPPP
AbdominalPPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP
Small Organs [1]PPPPPPPPP
Neonatal CephalicPPPPPPPPP
Adult Cephalic
Cardiac [2]PPPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPPP
Other (Urological)

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

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

13] Musculo Skeletal - Nerve Block

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

|5| Compound Imaging (Mview)

[6] 3D [7] CMM

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

Previously cleared via K100931 and K103152

11

CA421 (6250 system only)

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

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

[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) Смм

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

Previously cleared via K103152

12

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP:
AbdominalPPPPPPPP:
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP:
Small Organs [1]PPPPPPPP:
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP:
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP:
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP:
Musculo-skeletal Superficial [3]PPPPPPPP:
Other (Urological)PPPPPPPP:

CA430 (6200 and 6250 systems)

naging 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+CW+CFM+PD

[5] Compound Imaging (Mview)

(6) 3D (7) СММ

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

.

13

CA431 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP
Small Organs [1]PPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPP
Musculo-skeletal Superficial [3]PPPPPPP
Other (Urological)PPPPPPP

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+CW+CFM+PD

(5) Compound Imaging (Mview)

le] 3D (7) CMM

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

Previously cleared via K100931 and K103152

14

C5-2 R13 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPPP
AbdominalPPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP
Small Organs [1]PPPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPPP
Other (Urological)PPPPPPPPP

ostic ultrasound imaging or fluid flow analysis of human body as follows:

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| СММ

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

Previously cleared via K100931 and K103152

15

CA541 (6200 systems)

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

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

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

Previously cleared via K100931

16

CA541 (6250 systems)

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

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEE
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEE
Musculo-skeletal Superficial [3]EEEEEEE
Other (Urological)EEEEEEE

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

j4] Combined modes are: B+M+PW+CW+CFM+PD

[5| Compound Imaging (Mview)

(6) 3D [7] Смм

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

Previously cleared via Appendix E

17

CA621 (6250 systems only)

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

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPP

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

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

Previously cleared via K103152

18

CA631 (6200 and 6250 systems)

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

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

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 Skeleta] - Nerve Block

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

[5] Compound Imaging (Mview)

[6] 3D (7) СММ

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

Previously cleared via K100931 and K103152

19

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal CephalicEEEEEEEE
Adult Cephalic
Cardiac [2]EEEEEEEE
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEEE
Musculo-skeletal Superficial [3]EEEEEEEE
Other (Urological)

SC3123 (6200 and 6250 systems)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

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)

16] 3D |7] Смм

(8) Includes contrast (CnTi) in Adult Cardiac for left ventricie opacification and visualization of the left ventricular endocardial border

Previously cleared via Appendix E

20

LA332 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
OphthalmicPPPPPPPP
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac [2]PPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional [3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

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

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 Skeleta! - Nerve Block

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

[5] Compound Imaging (Mview)

[6] 3D [7] СММ

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

Previously cleared via K100931 and K103152

21

LA435 (6200 and 6250 systems)

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

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP
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+PW+CFM+PD

(5) Compound Imaging (Mview)

[6] 3D [7] СММ

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

Previously cleared via K100931 and K103152

22

LA522 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP
Small Organs [1]PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPP
Musculo-skeletal Superficial [3]PPPPPPP
Other (Urological)PPPPPPP

ended us e: 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

.

[5] Compound Imaging {Mview)

[6] 3D [7] CMM

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

Previously cleared via K100931 and K103152

23

LA523 (6200 and 6250 systems)

Clinical ApplicationMode of OperationsOther
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac [2]PPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

r fluid flow analysis of human body as follows: ontin Itracound imag

. [1] Small Organs includes Breast, Thyroid and Testicles

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

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

.

24

LA532 (6250 systems only)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

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

|5] Compound Imaging (Mview)

|6) 3D |7| CMM

ন্তু

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

Previously cleared via K103152

25

LA533 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal CephalicEEEEEEEE
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEEE
Musculo-skeletal Superficial [3]EEEEEEEE
Other (Urological)EEEEEEEE

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

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

Previously cleared via Appendix E

26

LA923 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

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

11 | 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] СММ

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

Previously cleared via K100931 and K103152

27

SL3116 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]EEEEEEE
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
(3)EEEEEEE
Musculo-skeletal Superficial [3]EEEEEEE
Other (Urological)

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

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) СММ

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

Previously cleared via Appendix E

28

PA023 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]
Neonatal CephalicPPPPPPPP
Adult Cephalic
Cardiac [2]PPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
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:

[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| СММ

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

.

Previously cleared via K100931 and K103152

29

PA122 (6200 and 6250 systems)

| | 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | P |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | P |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
[3] | | | | | | | | | | |
| 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+PW+CFM+PD

[5] Compound Imaging (Mview)

(6) 3D [7] CMM

[8] includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K100931 and K103152

30

PA230 (6200 and 6250 systems)

Clinical ApplicationMode of OperationsOthe
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)
Ophthalmic
FetalPPPPPPPPP
AbdominalPPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPP
Small Organs [1]PPPPPPPPP
Neonatal Cephalic
Adult CephalicPPPPPPPPP
Cardiac (2)PPPPPPPPP (8)P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

. . ﺎ ﻋ

[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)

ાંકા ૩૦ [7| CMM

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

ﻬﺎ ﻓﻬﻮ: ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

31

PA240 (6200 and 6250 systems)

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 |
|--------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P |
| Abdominal | P | P | P | P | P | P | P | | P | P |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P |
| Cardiac [2] | P | P | P | P | P | P | P | P | P (8) | P |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional
[3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

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

11 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] СММ

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

Previously cleared via K100931 and K103152

32

BC431 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]PPPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP (8)P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPP
Other (Urological)PPPPPPPP

{ } } Small Organs includes Breast, Thyroid and Testicles

|2| Cardiac is Adult and Pediatric

13] Musculo Skelctal - Nerve Block

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

[5] Compound Imaging (Mview)

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

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

Previously cleared via K100931 and K103152

33

BC441 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal Cephalic
Adult Cephalic
Cardiac [2]EEEEEEEE
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEEE
Musculo-skeletal Superficial [3]EEEEEEEE
Other (Urological)EEEEEEEE

[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] СММ

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

Previously cleared via Appendix ם

34

BL433 (6200 and 6250 systems) ni

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP
Small Organs [1]PPPPPPP
Neonatal CephalicPPPPPPP
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPP
Musculo-skeletal Superficial [3]PPPPPPP
Other (Urological)PPPPPPP

[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

سر.

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

Previously cleared via K100931 and K103152

35

BE1123 (6200 and 6250 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPPP

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/4D (7) CMM

[8] Includes contrast {CnTl] in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K100931 and K103152

36

EC123 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPP
TransvaginalPPPPPPPP
Transurethral
Intravascular
Peripheral VascularEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPPP

ન ધ analysis of human body an fallowo

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

Previously cleared via K100931,
K103152 and Appendix E

37

EC1123 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined [4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPP
AbdominalEEEEEEEE
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPPPP
TransvaginalPPPPPPPPP
Transurethral
Intravascular
Peripheral VascularEEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPPPP

id 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

15] Compound Imaging (Mview)

|6] 3D |7] СММ

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

·

Previously cleared via K100931, K103152 and Appendix E

38

TEE022 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)PPPPPPPPP
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

.

lvsis of h

|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)

ાંઠા ૩D [7] CMM

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

Previously cleared via K100931 and K103152

39

TEE132 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)PPPPPPPPPP
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

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

[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) Смм

.

] CMM

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

·

.

40

IOE323 (6200 and 6250 systems)

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPPPP
AbdominalPPPPPPPPP
Intraoperative (Abdominal)PPPPPPPPP
Intraoperative Neurological
PediatricPPPPPPPPP
Small Organs [1]PPPPPPPPP
Neonatal CephalicPPPPPPPPP
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPP
Laparoscopic
Musculo-skeletal Conventional
[3]PPPPPPPPP
Musculo-skeletal Superficial [3]PPPPPPPPP
Other (Urological)PPPPPPPPP

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: 8+M+PW+CFM+PD

|5) Compound Imaging (Mview)

|6| 3D |7| СММ

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

.

Previously cleared via K100931 and K103152

41

IOT332 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)EEEEEEEE
Intraoperative Neurological
PediatricEEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal CephalicEEEEEEEE
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEEE
Musculo-skeletal Superficial [3]EEEEEEEE
Other (Urological)EEEEEEEE

ﺔ ﺍﻟﺘﻨﺎﻳﺔ ﺍﻟﻤﺘﻨﺎﻭﻳﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍ abreic . ﮯ ﻋ body ar 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

[5] Compound Imaging (Mview)

[6] 3D [7] СММ

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

Previously cleared via Appendix E

42

IOT342 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalEEEEEEEE
AbdominalEEEEEEEE
Intraoperative (Abdominal)EEEEEEEE
Intraoperative Neurological
PediatricEEEEEEEE
Small Organs [1]EEEEEEEE
Neonatal CephalicEEEEEEEE
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEE
Laparoscopic
Musculo-skeletal Conventional
[3]EEEEEEEE
Musculo-skeletal Superficial [3]EEEEEEEE
Other (Urological)EEEEEEEE

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

Previously cleared via Appendix

E .

43

LP323 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
Ophthalmic
FetalPPPPPPP
AbdominalPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPP
Small Organs [1]PPPPPPP
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPP
LaparoscopicPPPPPPP
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

ન કરતા abrain af h

[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] СММ

.

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

.

44

TRT33 (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationвMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
4]Color Velocity
Mapping (TVM)Harmonic
lmaging (TEI)Other
Ophthalmic
FetalPPPbPPPP:
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs 1]
Neonatal Cephalic
Adult Cephalic
Cardiac 2
Transesophageal (Cardiac)
Transesophageal (Non Cardiac}
TransrectalPPPPPPPP:
TransvaginalPPPPPPPP:
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
િંગ્લ જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છ
Musculo-skeletal Superficial [3]
Other (Urological)PPP్రీPPPP: .

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

Previously cleared via K100931 and K103152

45

2CW (6200 and 6250 systems)

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows.
Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
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 VascularP
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)
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:

[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] СММ

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

Previously cleared via K100931 and K103152

Prescription Use Only Per 21 CFR 801 Part D Concurrence of Center for Devices and Radiological Health (CDRH)

.

46

5CW (6200 and 6250 systems)

Mode of Operations
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
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 VascularP
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

fluid flow analysis of hum as follows

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

| I ] 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] Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K100931 and K103152 .

47

Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
Doppler
(PD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other
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 VascularP
Laparoscopic
Musculo-skeletal Conventional
[3]
Musculo-skeletal Superficial [3]
Other (Urological)

HFCW (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 Skeleta] - Nerve Block

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

[5| Compound Imaging (Mview)

[6] 3D |7| CMM

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

Previously cleared via K100931
and K103152