Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

K222191 · Supersonic Imagine · IYN · Oct 28, 2022 · Radiology

Device Facts

• Record ID: K222191
• Device Name: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
• Applicant: Supersonic Imagine
• Product Code: IYN · Radiology
• Decision Date: Oct 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)]. In addition, the Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for: -Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen, - Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion. The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for: - Measurements of breast anatomical structures - Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast - Visualization of breast structures and micro-vascularization - · Visualization of breast morphology using shearwave elastography and micro-vascularization 2D mapping. The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound. This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

Device Story

Cart-based ultrasound system; utilizes various transducers (linear, curved, micro-convex, motorized) to acquire pulse-echo ultrasound data; processes signals for B-mode, M-mode, Doppler, ShearWave Elastography (SWE), and Contrast Enhanced Ultrasound (CEUS). Operated by trained healthcare professionals in hospitals or clinics. Provides real-time images, measurements, and quantification of tissue stiffness, viscosity, and vascularization. Output displayed on LCD monitor; used by physicians to characterize anatomical structures, breast masses, and liver disease. Includes optional automated protocols and improved image quality presets. System aids clinical decision-making by providing diagnostic information for patient management.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output (NEMA UD 2/UD 3), and biocompatibility (ISO 10993-1).

Technological Characteristics

Cart-based ultrasound system; LCD monitor; control panel with touchscreen. Transducers: linear, curved, micro-convex, motorized linear, phased array. Software: Linux (Debian 11). Connectivity: digital memory, external printer. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatibility: ISO 10993-1. Acoustic output: NEMA UD-2, NEMA UD-3.

Indications for Use

Indicated for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, and doppler fluid flow analysis in adult and pediatric patients. Applications include abdominal, small organs, musculoskeletal, superficial musculoskeletal, vascular, intraoperative, OB-GYN, pelvic, pediatric, urology, trans-rectal, trans-vaginal, neonatal/adult cephalic, and non-invasive cardiac imaging. Used as an aid in clinical management of liver disease and breast masses.

Regulatory Classification

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.

Predicate Devices

• AIXPLORER® MACH range Ultrasound Imaging System (K203645)

Reference Devices

• AIXPLORER® MACH range Ultrasound Imaging System (K202455)
• Aplio i900, i800, i700 V2 (K173090)
• Resona 7 (K171233)

Submission Summary (Full Text)

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October 28, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

SuperSonic Imagine % Shalyna Bansropun Regulatory Affairs Manager Zac de l`enfant 135 rue Emilien Gautier Aix en Provence, 13290 FRANCE

Re: K222191

Trade/Device Name: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC MACH20, SUPERSONIC MACH40 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 23, 2022 Received: September 28, 2022

Dear Shalyna Bansropun:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### 510{k) Number (if known) K222191

### Device Name

AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20 and SUPERSONIC MACH 40

### Indications for Use (Describe)

The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].

In addition, the Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:

-Measurements of abdominal anatomical structures,

- Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- Measurements of brightness ratio between liver and kidney,
- Visualization of abdominal vascularization, microvascularization and perfusion,
- Quantification of abdominal vascularization and perfusion.

The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

- Measurements of breast anatomical structures
- Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- · Visualization of breast morphology using shearwave elastography and micro-vascularization 2D mapping.

The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

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)

FORM FDA 3881 (6/20)

Page 1 of 6

PSL' Publishing Services (301) - 443.6740

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Image /page/3/Picture/0 description: The image shows the logo for Hologic SuperSonic Imagine. The word "HOLOGIC" is in dark blue, while "SUPERSONIC" is in gray. The word "Imagine" is in light blue. The TM symbol is next to the word "SUPERSONIC".

# K222191

# 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.

- 1. Submitter's name, address, telephone number, contact person

| Submitted by: | Distributed by: |
|------------------------------------------|--------------------------|
| SuperSonic Imagine, S.A. | Hologic Headquarters. |
| Zac de l'Enfant 135 Rue Émilien Gautier | 250 Campus Drive |
| 13290 Aix-En-Provence | Marlborough, MA 01752 |
| FRANCE | USA |
| Telephone: [phone] | Tel: [phone] |
| E-mail: [e-mail] | Fax: [phone] |
| | E-mail: [e-mail] |

Corresponding Official: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: [phone]

## Date: Sept-22-2022

- 2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Ultrasound Diagnostic System with Accessories

Proprietary Name:

- AIXPLORER® MACH / SUPERSONIC MACH Ultrasound Diagnostic Systems o
- O AIXPLORER® MACH 30 / SUPERSONIC MACH30,
- AIXPLORER® MACH 20 / SUPERSONIC MACH 20, O
- SUPERSONIC MACH 40 o

Classification: Class II

| Classification Name: | 21 CFR Section | Product Code |
|------------------------------------------|----------------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

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Image /page/4/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the word "SUPERSONIC" is in gray and blue. The word "Imagine" is in gray.

# 3. Substantially Equivalent/Predicate Devices

| Primary Predicate Device | AIXPLORER® MACH range Ultrasound Imaging System (K203645), cleared<br>on 06/29/2021 |
|--------------------------|-------------------------------------------------------------------------------------|
| Reference devices | AIXPLORER® MACH range Ultrasound Imaging System (K202455),<br>cleared on 12/29/2020 |
| | Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 |
| | Resona 7 (K171233) cleared on 09/12/2017 |

# 4. Description of Device

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.

The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.

The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.

# 5. Indication for Use

The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.

The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); ShearWave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow); (B/SWE); (B/PW); (B/PW/Color Flow); (B/Color flow/SWE); (B/CW) ; (B/Mmode/Color flow); (B/Strain Elastography/SWE)]."

In addition, the Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:

- -Measurements of abdominal anatomical structures,

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Image /page/5/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC" are in gray. The word "Imagine" is in light blue and is located below the word "SUPERSONIC".

- -Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
- -Measurements of brightness ratio between liver and kidney,
- -Visualization of abdominal vascularization, microvascularization and perfusion,
- -Quantification of abdominal vascularization and perfusion.

The shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

- -Measurements of breast anatomical structures
- -Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- -Visualization of breast structures and micro-vascularization
- -Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping.

The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office.

This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

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Image /page/6/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC imagine" are in gray and blue. The word "SUPERSONIC" is in gray, and the word "imagine" is in blue.

# 6. Summary of Technological Characteristics – New Device compared to Predicates

| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical<br>System | Mindray medical<br>International | SuperSonic Imagine |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aixplorer MACH range sw<br>V3<br>(predicate) | Aixplorer MACH range sw<br>V2.1<br>(Reference) | Aplio i900, i800 and<br>i700 V2.0<br>(Reference) | Resona 7<br>(Reference) | AIXPLORER® MACH /<br>SUPERONIC MACH<br>range sw V4 |
| 510(k) Number | K203645 | K202455 | K173090 | K171233 | K222191 |
| Classification<br>Name | Ultrasonic Pulsed Doppler<br>Imaging System (892.1550)<br>Ultrasonic Pulsed Echo<br>Imaging System (892.1560)<br>Diagnostic Ultrasound<br>Transducer (892.1570) | Ultrasonic Pulsed Doppler<br>Imaging System (892.1550)<br>Ultrasonic Pulsed Echo<br>Imaging System (892.1560)<br>Diagnostic Ultrasound<br>Transducer (892.1570) | Identical | Identical | Identical |
| Class | Class II | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasound imaging,<br>soft tissue elasticity imaging,<br>fluid flow analysis of the<br>human body | Diagnostic ultrasound imaging,<br>soft tissue elasticity imaging,<br>fluid flow analysis of the<br>human body | Diagnostic<br>ultrasound<br>imaging or fluid flow<br>analysis of the<br>human<br>body | Diagnostic Ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body | Identical to K203645 |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical<br>System | Mindray medical<br>International | SuperSonic Imagine |
| Indication for Use | The SuperSonic Imagine<br>AIXPLORER® MACH/<br>SUPERSONIC MACH range<br>ultrasound diagnostic<br>systems and transducers are<br>intended for general purpose<br>pulse echo ultrasound<br>imaging, soft tissue<br>viscoelasticity imaging,<br>doppler fluid flow analysis of<br>the human body.<br>The SuperSonic Imagine<br>AIXPLORER® MACH/<br>SUPERSONIC MACH<br>ultrasound diagnostic<br>systems are indicated for use<br>in the following applications,<br>for imaging and<br>measurement of anatomical<br>structures: Abdominal, Small<br>Organs, Musculoskeletal,<br>Superficial Musculoskeletal,<br>Vascular, Peripheral<br>Vascular, Intraoperative, OB-<br>GYN, Pelvic, Pediatric,<br>Urology, Trans-rectal, Trans-<br>vaginal and Neonatal/Adult<br>Cephalic, Non-invasive<br>Cardiac.<br>In addition, the SuperSonic<br>Imagine AIXPLORER®<br>MACH/ SUPERSONIC<br>MACH ultrasound diagnostic<br>systems and associated<br>transducers are intended for: | The SuperSonic Imagine<br>AIXPLORER® MACH/<br>SUPERSONIC MACH range<br>ultrasound diagnostic<br>systems and transducers are<br>intended for general purpose<br>pulse echo ultrasound<br>imaging, soft tissue<br>viscoelasticity imaging,<br>doppler fluid flow analysis of<br>the human body.<br>The SuperSonic Imagine<br>AIXPLORER® MACH/<br>SUPERSONIC MACH<br>ultrasound diagnostic<br>systems are indicated for use<br>in the following applications,<br>for imaging and<br>measurement of anatomical<br>structures: Abdominal, Small<br>Organs, Musculoskeletal,<br>Superficial Musculoskeletal,<br>Vascular, Peripheral<br>Vascular, Intraoperative, OB-<br>GYN, Pelvic, Pediatric,<br>Urology, Trans-rectal, Trans-<br>vaginal and Neonatal/Adult<br>Cephalic, Non-invasive<br>Cardiac.<br>In addition, the SuperSonic<br>Imagine AIXPLORER®<br>MACH/ SUPERSONIC<br>MACH ultrasound diagnostic<br>systems and associated<br>transducers are intended for: | The diagnostic<br>ultrasound<br>systems Aplio i900<br>Model TUS-<br>AI900, Aplio i800<br>Model TUS-<br>AI800, Aplio i700<br>Model TUS-<br>AI700, Aplio i600<br>Model TUS-<br>AI600, are indicated<br>for the visualisation of<br>structures, and<br>dynamic processes<br>with the human body<br>using ultrasound and<br>to provide image<br>information for<br>diagnosis in the<br>following applications<br>: fetal, abdominal,<br>intraoperative<br>(abdominal),<br>pediatric, small<br>organs, transvaginal,<br>transrectal, neonatal<br>cephalic, adult<br>cephalic, cardica<br>(both adult and<br>pediatric), peripheral | The Resona<br>7/Resona<br>7CV/Resona<br>7EXP/Resona<br>7S/Resona 7OB<br>diagnostic ultrasound<br>system is applicable for<br>adults, pregnant<br>women, pediatric<br>patients and neonates.<br>It is intended for use in<br>fetal, abdominal, intra-<br>operative (abdominal,<br>thoracic, and vascular),<br>pediatric, small organ<br>(breast, thyroid, testes),<br>neonatal cephalic, adult<br>cephalic,<br>trans-rectal,<br>transvaginal,muscul<br>o-skeletal (conventional,<br>superficial), cardiac<br>adult, cardiac pediatric,<br>transesoph. (cardiac),<br>peripheral vessel and<br>urology exams. | Identical to K203645<br>Additional information<br>for clarification on "<br>Operator qualification<br>and device use<br>settings" and "mode of<br>operation". |
| SuperSonic Imagine | SuperSonic Imagine | Canon Medical<br>System | Mindray medical<br>International | SuperSonic Imagine | |
| -Measurements of abdominal<br>anatomical structures, | -Measurements of abdominal<br>anatomical structures, | vascular,<br>transoesophageal,<br>musculoskeletal (both<br>conventional and<br>superficial) and<br>laparoscopic. | | | |
| - Measurements of broad<br>band shear wave speed, and<br>tissue stiffness in internal<br>structures of the liver and the<br>spleen, | - Measurements of broad<br>band shear wave speed, and<br>tissue stiffness in internal<br>structures of the liver and the<br>spleen, | | | | |
| - Measurements of<br>brightness ratio between liver<br>and kidney, | - Measurements of<br>brightness ratio between liver<br>and kidney, | | | | |
| - Visualization of abdominal<br>vascularization,<br>microvascularization and<br>perfusion, | - Visualization of abdominal<br>vascularization,<br>microvascularization and<br>perfusion, | | | | |
| - Quantification of abdominal<br>vascularization and<br>perfusion. | - Quantification of abdominal<br>vascularization and<br>perfusion. | | | | |
| The shearwave speed, beam<br>attenuation, viscosity and<br>stiffness measurements, the<br>brightness ratio, the<br>visualization of<br>vascularization,<br>microvascularization and<br>perfusion, the quantification<br>of vascularization and<br>perfusion may be used as an<br>aid to clinical management of<br>adult and pediatric patients<br>with liver disease. | The shearwave speed, beam<br>attenuation, viscosity and<br>stiffness measurements, the<br>brightness ratio, the<br>visualization of<br>vascularization,<br>microvascularization and<br>perfusion, the quantification<br>of vascularization and<br>perfusion may be used as an<br>aid to clinical management of<br>adult and pediatric patients<br>with liver disease. | | | | |
| SuperSonic Imagine | SuperSonic Imagine | Canon Medical<br>System | Mindray medical<br>International | SuperSonic Imagine | |
| Furthermore, the SuperSonic<br>Imagine MACH ultrasound<br>diagnostic systems and<br>associated transducers are<br>intended for: | |…