IMACOR ZURA EVO IMAGING SYSTEM

K142054 · Imacor, Inc. · IYO · Sep 29, 2014 · Radiology

Device Facts

• Record ID: K142054
• Device Name: IMACOR ZURA EVO IMAGING SYSTEM
• Applicant: Imacor, Inc.
• Product Code: IYO · Radiology
• Decision Date: Sep 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The Zura-EVO Imaging System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indicated for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

Device Story

Zura-EVO is a mobile, software-controlled diagnostic ultrasound system for cardiac imaging. It acquires ultrasound echo data via ClariTEE (transesophageal) or TTE (transthoracic) probes; data is processed by a digital beam-former and displayed on a touch-screen console. The system supports B-mode and Color Doppler imaging; includes measurement/calculation packages for anatomical structures; and provides optional 3-lead ECG display. Used in clinical settings like the ICU by physicians for episodic cardiac assessment. The device features a battery-powered console for bedside mobility and software interlocks (20-minute limit on continuous imaging) to prevent mucosal tissue overheating. Output assists physicians in clinical diagnosis and monitoring of cardiac function.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601 3rd Ed), acoustic output (IEC 60601-2-37), biocompatibility (ISO 10993 series), and sterilization validation (ISO 11135-1). No clinical data presented.

Technological Characteristics

Mobile ultrasound system with digital beam-former. Components: ClariTEE probe (disposable, ETO sterilized) and TTE probe. Imaging modes: B-mode, Color Doppler. Connectivity: DICOM module. Software: ImaCor Zura software with touch-screen GUI. Safety: IEC 60601-1, IEC 60601-2-37, ISO 14971. Battery-powered console. Software interlock for continuous imaging (20 min).

Indications for Use

Indicated for episodic assessment of cardiac function via TEE in clinical settings (e.g., ICU) for up to 72 hours, and imaging/assessment of cardiac anatomy and function via TTE. Intended for use by physicians for clinical diagnosis.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ImaCor Zura (K080223, K100989)
• Ultrasonix SonixTablet (K102997)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

September 29, 2014

ImaCor, Inc. % Mr. James W. Monroe Director of QA/RA 839 Stewart Avenue, Suite 3 GARDEN CITY NY 11530

Re: K142054 Trade/Device Name: Zura-EVO Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 30, 2014 Received: July 31, 2014

Dear Mr. Monroe:

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 Zura-EVO Imaging System, as described in your premarket notification:

Transducer Model Number

ClariTEE Probe

TTE probe SA4-2/24

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

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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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


for

Janine M. Morris 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) K142054

Device Name Zura-EVO Imaging System

#### Indications for Use (Describe)

1. The Zura-EVO System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes.

2. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indical for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs.

3. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### FOR FDA USE ONLY

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#### Zura-EVO Imaging System

Intended Use: When used with the ClariTEE probe -- The episodic assessment of cardian using transesophageal echocardiography (TEE). It is indical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs. When used with the SA4-2/24 Phased Array Transducer (TTE Probe) it is intended for Diagnostic Ultrasound imagining or fluid analysis of the human body as follows:

| | | Mode of Operation | | | | | | | |
|--------------------------------|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|------------------|
| Clinical Application | Probe | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other<br>(Notes) |
| Opthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative¹ | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ² | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | SA4-2/24 Phased<br>Array Transducer<br>(TTE Probe) | N | | | | N | | | |
| Transesophageal | ClariTEE Probe | P | | | | P | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Transcranial | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| MSK Conventional | | | | | | | | | |
| MSK Superficial | | | | | | | | | |
| Vascular Access | | | | | | | | | |
| Nerve Block | | | | | | | | | |
| Other | | | | | | | | | |

N = New Indication; P = Previously cleared under K080223, K100989

(Division Sign-off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K

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#### DIAGNOSTIC ULTRASOUND INDICATION FOR USE FORM

#### ClariTEE Probe

Intended Use: When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indicated for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs.

| | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other<br>(Notes) |
| Opthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative1 | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ² | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | | | | | | | | |
| Transesophageal | P | | | | P | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

N = New Indication; P = Previously cleared under K080223, K100989

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#### DIAGNOSTIC ULTRASOUND INDICATION FOR USE FORM

#### SA4-2/24 Phased Array Transducer (TTE Probe)

| | Mode of Operation | | | | | | | |
|-----------------------------|-------------------|---|---------------|---------------|------------------|------------------|-------------------|------------------|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Power<br>Doppler | Combined<br>Modes | Other<br>(Notes) |
| Opthalmic | | | | | | | | |
| Fetal | | | | | | | | |
| Abdominal | | | | | | | | |
| Intraoperative¹ | | | | | | | | |
| Intraoperative Neurological | | | | | | | | |
| Pediatric | | | | | | | | |
| Small Organ² | | | | | | | | |
| Neonatal Cephalic | | | | | | | | |
| Adult Cephalic | | | | | | | | |
| Cardiac | N | | | | N | | | |
| Transesophageal | | | | | | | | |
| Transrectal | | | | | | | | |
| Transvaginal | | | | | | | | |
| Transurethral | | | | | | | | |
| Transcranial | | | | | | | | |
| Peripheral Vascular | | | | | | | | |
| Laparoscopic | | | | | | | | |
| MSK Conventional | | | | | | | | |
| MSK Superficial | | | | | | | | |
| Vascular Access | | | | | | | | |
| Nerve Block | | | | | | | | |
| Other | | | | | | | | |

Intended Use: Diagnostic Ultrasound imagining or fluid analysis of the human body as follows:

N = New Indication; P = Previously cleared under K080223, K100989

(Division Sign-off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K

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### 5. 510(K) Summary

## 510(K) SUMMARY

## Zura-EVO Imaging System

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

ImaCor Inc 839 Stewart Ave Unit 3 Garden City, NY 11530 Phone: [phone], Facsimile: [phone] Contact Person: James W. Monroe; [e-mail]. 732-718-9199

Date Prepared: July 24, 2014

#### Name of Device and Name/Address of Sponsor

### Zura-EVO Imaging System

ImaCor Inc 839 Stewart Ave Unit 3 Garden City, NY 11530

#### Common or Usual Name

Ultrasound Imaging System

#### Classification Name

Ultrasonic Pulsed Doppler Imaging System (892.1550) Ultrasonic Pulsed Echo Imaging System (892.1560) with a Diagnostic Ultrasonic Transducer (892.1570)

Product Codes IYO, IYN, ITX,

Device Class II

Predicate Devices ImaCor Zura K080223, K100989 Ultrasonix SonixTablet K102997

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## Intended Use / Indications for Use

1. The Zura-EVO Imaging System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes.

2. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indicated for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs.

3. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

## Device Description

The Zura-EVO Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system. Its function is to acquire ultrasound echo data and display it in B-Mode, or Color Doppler Mode on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.

The system has an optional electrocardiography (ECG) display feature and support for a 3-

lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has measurements and calculations, image storage and review, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.

The Zura-EVO Imaging System consists of the following major components:

1. Ultrasound Machine: A predicate device ultrasound machine (K102997) 2. Ultrasound Probes

a. ClariTEE Probe: A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes that enables long term use in clinical settings such as the ICU. This probe has predicate coverage under K080223 and K100969.

b. TTE probe SA4-2/24: Transthoracic probe has a predicate coverage under K102997

3. Ultrasound Imaging Software: Ultrasound imaging functions are

controlled via the ImaCor Zura software. The Graphical User Interface, which is the piece of software exposed to the user, communicates user inputs to the Ultrasound Imaging Platform which interfaces with the Ultrasound Transducer. The ImaCor Zura

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software also communicates with the probe directly to monitor the probe's lifespan. Orientation and position of the probe is controlled manually by the user.

## Description of design modifications

The Zura-EVO is different from the original Zura design in that the EVO GUI is via a touch display screen. A miniaturized keyboard and mouse are provided but are optional. The EVO mains power supply includes a battery so that the machine does not need to be rebooted when moving from bedside to bedside in a critical care setting.

Finally, while the Zura is provided only with the 72 hr. miniaturized ClariTEE probe (ultrasound transducer). The EVO is provided with two transducers; the 72 hr. ClariTEE probe and an optional TTE probe.

The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37.

There are two modes of imaging; type B and color flow Doppler.

## Non-Clinical Testing

The following non-clinical testing was conducted: electrical safety to meet the requirements of IEC 60601 3rd Edition, Sterility to demonstrate and SAL 10 106, aged acceleration testing, and acoustic output testing to meet the requirements of IEC 60601-2-37.

## Comparison to Predicate Device

The Zura-EVO Ultrasound Scanner is substantially equivalent to the predicate devices listed below with respect to intended use/indications for use, principles of operation and technological characteristics.

The Zura-EVO Ultrasound Scanner includes a digital beam-former that is identical in function to the predicate devices beam-former. It allows transmitting and receiving signals through the

ultrasound transducers. The ultrasound transducers are identical to the ones used on predicate devices.

The backend processing is also similar to the predicate devices and vields an ultrasound image in realtime for diagnosis purposes.

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| Guidance ( guidance<br>document section ref.) | Design<br>Characteristic | FDA Consensus<br>Standard | Recognition Number |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | Risk Assessment | ISO 14971:2007<br>Medical devices -<br>Application of risk<br>management to<br>medical devices | 5-40 |
| | Acoustic Output<br>(Track 1) | EN 60601-2-37:2008<br>Medical electrical<br>equipment -- Part 2-<br>37: Particular<br>requirements for the<br>basic safety and<br>essential performance<br>of ultrasonic medical<br>diagnostic and<br>monitoring equipment | |
| | Thermal<br>Mechanical and<br>Electrical Safety | EN 60601-1:2006<br>Medical electrical<br>equipment -- Part 1:<br>General requirements<br>for safety | 5-77 |
| | | EN 60601-2-37:2008<br>Medical electrical<br>equipment -- Part 2-<br>37: Particular<br>requirements for the<br>basic safety and<br>essential performance<br>of ultrasonic medical<br>diagnostic and<br>monitoring equipment | 5-53 |
| | Patient Contacting<br>Materials | Biological evaluation<br>of medical devices<br>EN ISO 10993-1 2009 | 2-179 |
| | | EN ISO 10993-5 2009 | 2-153 |
| | EN ISO 10993-6 2009 | 2-120 | |
| | EN ISO 10993-7 2007 | 14-335 | |
| | EN ISO 10993-10 2010 | 2-173 | |
| | EN ISO 10993-11 2009 | 2-176 | |
| | EN ISO 10993-12 2012 | 2-191 | |
| Cleaning<br>Disinfection,<br>Sterilization and<br>Pyrogenicity | EN ISO 11135-1:2007<br><br>Sterilization of health<br>care products -<br>Ethylene oxide - Part<br>1: Requirements for<br>development,<br>validation and routine<br>control of a<br>sterilization process<br>for medical devices<br>(ISO 11135-1:2007) | 14-228 | |
| Software/Firmware | EN 62304<br><br>Medical Device<br>Software - Software<br>Life Cycle Processes | 13-32 | |
| Labeling<br>EMC | EN 60601-1-2:2007<br><br>Medical electrical<br>equipment -- Part 1-2:<br>General requirements<br>for basic safety and<br>essential performance<br>- Collateral standard:<br>Electromagnetic<br>compatibility -<br>Requirements and<br>tests | 5-53 | |

# Table of FDA Consensus Standards

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# Substantial Equivalence

The new device (EVO) has significant predicate coverage

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| | Zura -EVO<br>Subject Device | Zura with ClariTEE<br>Probe (K080223,<br>K100989) | Ultrasonix Sonix-Tablet<br>K102997 | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------|
| Intended Use | Intended for the following<br>applications: Cardiac and ,<br>Transesophageal.<br>Measurement and<br>calculation packages that<br>provide information of<br>anatomical structures that<br>may be used by a physician<br>for clinical diagnosis<br>purposes.<br>2. When used with the<br>ClariTEE probe -- The<br>episodic assessment of<br>cardiac function using<br>transesophageal<br>echocardiography (TEE). It<br>is indicated for use in clinical<br>settings including long term<br>settings such as the ICU for<br>an indwelling time not to<br>exceed 72 hrs.<br>3. When used with the TTE<br>probe is intended for<br>imaging and assessment of<br>Cardiac anatomy and<br>function | Intended for use in<br>the episodic<br>assessment of cardiac<br>function<br>using<br>transesophageal<br>echocardiography. It<br>is indicated for use in<br>clinical settings,<br>including<br>long-term settings<br>such as the ICU, for<br>an indwelling time<br>period not to exceed<br>72 hours. The ImaCor<br>Diagnostic ultrasound<br>imaging - TEE | Intended for the following<br>applications: Abdominal,<br>Cardiac, I ntraolperative<br>Neurological, Fetal, Pediatric,<br>Small Parts, Neonatal/ Adult<br>Cephalic, OB/GYN,<br>Transesophageal,<br>Transrectal,Transvaginal,<br>Peripheral Vascular,<br>Musculoskeletal conventional,<br>Musculoskeletal superficial,<br>Pelvic, Nerve Block, Vascular<br>Access, Transcranial. The<br>system also provides the<br>ability to measure anatomical<br>structures {fetal, abdominal,<br>pediatric, small organ,<br>cardiac, transrectal,<br>transvaginal, peripheral<br>vessel, musculoskeletal} and<br>provides calculation packages<br>that provide information to<br>the clinician that may be used<br>adjunctively with other<br>medical data obtained by a<br>physician for clinical<br>diagnosis purposes. | Power Source | Nominal 120 Vac, 50/60 hz, single phase | Nominal 120 Vac, 50/60 hz, single phase | Nominal 120 Vac, 50/60 hz, single phase |
| | Diagnostic ultrasound<br>imaging multimodality<br>includes TEE, TTM, Linear | | Diagnostic ultrasound<br>imaging multimodality<br>includes TEE, TTM, Linear | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| User Population | All except pediatric for<br>TEE | All except pediatric for<br>TEE | All | Software | Moderate Concern | Moderate Concern | Moderate Concern |
| Technological<br>Characteristics | Ultrasound diagnostic with<br>miniaturized TEE, TTE, Linear<br>Software controls type B mode<br>imaging and color flow doppler | Ultrasound diagnostic<br>with<br>miniaturized TEE probe<br>Software controls type B<br>mode imaging and color<br>flow doppler | Ultrasound diagnostic with<br>miniaturized probe/transducer<br>Software controls type B mode<br>imaging and color flow doppler | Sterilization | ETO; disposable TEE probe provided sterile<br>Other probes - standard disinfection | ETO; disposable probe provided sterile | Reusable, standard disinfectant procedure applied |
| Major System<br>Components | Ultrasound machine<br>containing beam-forming<br>architecture<br>Disposable single use probe<br>(miniaturized)<br>Effective diameter of 5.5 mm.<br>Phased array transducer.<br>Detachable handle<br>Software<br>Quantitative software aids<br>TTE and Linear probe | Ultrasound machine<br>containing beam-forming<br>architecture<br>Disposable single use<br>probe<br>(miniaturized)<br>Effective diameter of 5.5<br>mm.<br>Phased array transducer.<br>Detachable handle<br>Software<br>Quantitative software<br>aids | Ultrasound machine<br>containing beam-forming<br>architecture<br>Disposable single use probe<br>(miniaturized)<br>Effective diameter of 5.5 mm.<br>Phased array transducer.<br>Detachable handle<br>Software<br>Quantitative software aids<br>Transducer list includes identical<br>TTE, Linear probe | Acoustic Output | Acoustic Output Track 1 device | Acoustic Output Track 1 device | Acoustic Output Track 3 device |
| Accessory | Three lead ECG (not for diagnostic purposes) | Three lead ECG (not for diagnostic purposes) | Three lead ECG (not for diagnostic purposes) | | | | |

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1. The ImaCor EVO is substantially equivalent to the ImaCor Zura and ClariTEE probe cleared for marketing by the FDA under K080223 and K100989. These 510K coverages are for the ImaCor ClariTEE probe

2. The EVO is substantially equivalent to the Sonix-Tablet, manufactured by Ultrasonix Medical Corporation and cleared for marketing by the FDA under K102997. Ultrasonix is the OEM for the EVO and the Sonix-Tablet is the EVO's twin. The Linear and TTE transducers provided with the EVO are covered with the Sonix-Tablet under K102997