(62 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and software control without mentioning any AI/ML capabilities.
No
The device is described as a diagnostic ultrasound system used for imaging and assessment of anatomical structures, not for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section states that the measurement and calculation packages provide "information of anatomical structures that may be used by a physician for clinical diagnosis purposes." Additionally, the "Device Description" explicitly calls the Zura-EVO Imaging System a "diagnostic ultrasound system."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and lists major components including an "Ultrasound Machine" and "Ultrasound Probes," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Zura-EVO System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This examination is performed outside of the living body.
- Zura-EVO System Function: The Zura-EVO System is an ultrasound imaging system. It uses ultrasound waves to create images of internal anatomical structures (specifically cardiac and transesophageal). This is an in vivo (within the living body) diagnostic method.
- Intended Use: The intended use clearly states that the system provides information of anatomical structures that may be used by a physician for clinical diagnosis purposes. This is achieved through imaging the body directly, not by analyzing specimens.
Therefore, the Zura-EVO System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
-
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.
-
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.
-
When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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:
- Ultrasound Machine: A predicate device ultrasound machine (K102997)
- 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 - 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Transesophageal
Indicated Patient Age Range
All except pediatric for TEE
Intended User / Care Setting
Physician, clinical settings including long term settings such as the ICU
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)
Non-Clinical Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
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
1
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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142054
Device Name Zura-EVO Imaging System
Indications for Use (Describe)
-
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.
-
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.
-
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)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 | |||||
| Doppler | CW | ||||||||
| Doppler | Color | ||||||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| Modes | Other | ||||||||
| (Notes) | |||||||||
| Opthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative¹ | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ² | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | SA4-2/24 Phased | ||||||||
| Array Transducer | |||||||||
| (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
4
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 | |||||
| Doppler | CW | |||||||
| Doppler | Color | |||||||
| Doppler | Power | |||||||
| Doppler | Combined | |||||||
| Modes | Other | |||||||
| (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
5
DIAGNOSTIC ULTRASOUND INDICATION FOR USE FORM
SA4-2/24 Phased Array Transducer (TTE Probe)
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | |||||
| Doppler | CW | |||||||
| Doppler | Color | |||||||
| Doppler | Power | |||||||
| Doppler | Combined | |||||||
| Modes | Other | |||||||
| (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
6
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: (732) 718-9199, Facsimile: (516) 393-0969 Contact Person: James W. Monroe; imonroe@imacorinc.com. 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
7
Intended Use / Indications for 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 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:
- 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
- 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
8
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.
9
| Guidance ( guidance
document section ref.) | Design
Characteristic | FDA Consensus
Standard | Recognition Number |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| | Risk Assessment | ISO 14971:2007
Medical devices -
Application of risk
management to
medical devices | 5-40 |
| | Acoustic Output
(Track 1) | EN 60601-2-37:2008
Medical electrical
equipment -- Part 2-
37: Particular
requirements for the
basic safety and
essential performance
of ultrasonic medical
diagnostic and
monitoring equipment | |
| | Thermal
Mechanical and
Electrical Safety | EN 60601-1:2006
Medical electrical
equipment -- Part 1:
General requirements
for safety | 5-77 |
| | | EN 60601-2-37:2008
Medical electrical
equipment -- Part 2-
37: Particular
requirements for the
basic safety and
essential performance
of ultrasonic medical
diagnostic and
monitoring equipment | 5-53 |
| | Patient Contacting
Materials | Biological evaluation
of medical devices
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
Disinfection,
Sterilization and
Pyrogenicity | EN ISO 11135-1:2007
Sterilization of health
care products -
Ethylene oxide - Part
1: Requirements for
development,
validation and routine
control of a
sterilization process
for medical devices
(ISO 11135-1:2007) | 14-228 | |
| Software/Firmware | EN 62304
Medical Device
Software - Software
Life Cycle Processes | 13-32 | |
| Labeling
EMC | EN 60601-1-2:2007
Medical electrical
equipment -- Part 1-2:
General requirements
for basic safety and
essential performance
- Collateral standard:
Electromagnetic
compatibility -
Requirements and
tests | 5-53 | |
Table of FDA Consensus Standards
10
Substantial Equivalence
The new device (EVO) has significant predicate coverage
11
| | Zura -EVO
Subject Device | Zura with ClariTEE
Probe (K080223,
K100989) | Ultrasonix Sonix-Tablet
K102997 | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------|
| Intended Use | 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 | Intended for use in
the episodic
assessment of cardiac
function
using
transesophageal
echocardiography. It
is indicated for use in
clinical settings,
including
long-term settings
such as the ICU, for
an indwelling time
period not to exceed
72 hours. The ImaCor
Diagnostic ultrasound
imaging - TEE | Intended for the following
applications: Abdominal,
Cardiac, I ntraolperative
Neurological, Fetal, Pediatric,
Small Parts, Neonatal/ Adult
Cephalic, OB/GYN,
Transesophageal,
Transrectal,Transvaginal,
Peripheral Vascular,
Musculoskeletal conventional,
Musculoskeletal superficial,
Pelvic, Nerve Block, Vascular
Access, Transcranial. The
system also provides the
ability to measure anatomical
structures {fetal, abdominal,
pediatric, small organ,
cardiac, transrectal,
transvaginal, peripheral
vessel, musculoskeletal} and
provides calculation packages
that provide information to
the clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
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
imaging multimodality
includes TEE, TTM, Linear | | Diagnostic ultrasound
imaging multimodality
includes TEE, TTM, Linear | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| User Population | All except pediatric for
TEE | All except pediatric for
TEE | All | Software | Moderate Concern | Moderate Concern | Moderate Concern |
| Technological
Characteristics | Ultrasound diagnostic with
miniaturized TEE, TTE, Linear
Software controls type B mode
imaging and color flow doppler | Ultrasound diagnostic
with
miniaturized TEE probe
Software controls type B
mode imaging and color
flow doppler | Ultrasound diagnostic with
miniaturized probe/transducer
Software controls type B mode
imaging and color flow doppler | Sterilization | ETO; disposable TEE probe provided sterile
Other probes - standard disinfection | ETO; disposable probe provided sterile | Reusable, standard disinfectant procedure applied |
| Major System
Components | Ultrasound machine
containing beam-forming
architecture
Disposable single use probe
(miniaturized)
Effective diameter of 5.5 mm.
Phased array transducer.
Detachable handle
Software
Quantitative software aids
TTE and Linear probe | Ultrasound machine
containing beam-forming
architecture
Disposable single use
probe
(miniaturized)
Effective diameter of 5.5
mm.
Phased array transducer.
Detachable handle
Software
Quantitative software
aids | Ultrasound machine
containing beam-forming
architecture
Disposable single use probe
(miniaturized)
Effective diameter of 5.5 mm.
Phased array transducer.
Detachable handle
Software
Quantitative software aids
Transducer list includes identical
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) | | | | |
12
-
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
-
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