The Pocket Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology
Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric
Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Device Description

The Pocket Ultrasound System (Model: C10, C10TX, C10RLpro) is designed to be a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data through an off-the-shelf (OTS) Android device. the system mainly includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.

The system is only intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Pocket Ultrasound System comprises the following:

. A commercial off-the-shelf (COTS) Android smartphone/tablet device.
. the software application (MY USG) running as an App on the COTS device with Android system.
. The ultrasound equipment/Transducers: C10 / C10TX / C10RL / C10RLpro
- The 4 models have no difference in composition and performance parameters, only the appearance and battery capacity are different.
Accessory: Wireless Battery Charger & Power Adapter

Different type transducers are available for the Pocket Ultrasound System (Model: C10, C10TX, C10RL, C10RLpro), the frequencies are 2.5 MHz, 3.2 MHz and 7.5MHz respectively depending on different transducer. The Pocket Ultrasound System is designed with four ultrasound modes of operation, including B-mode, Combination Mode (B+M mode), Color Doppler mode and Pulsed Wave Doppler mode.

Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under Bmode, while coloring blood flow can be seen under Color Doppler mode and Pulsed Wave Doppler mode. Combination mode B+M-mode is the combination of the B-mode and M-mode of operation, superimposed on the display. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line, so it's usually applied in diagnosis of cardiovascular diseases.

The system provides real-time images for tissues, organs or blood flow via touch screen of the COTS Android smartphone/tablet device, which, in combination with the embedded software system contained in the ultrasound device, provides users a friendly and convenient graphical interface and makes users be able to easily control the whole system.

AI/ML Overview

This document is a 510(k) summary for the Pocket Ultrasound System, focusing on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI-powered medical device where performance characteristics beyond basic technical specifications (like diagnostic accuracy metrics) would be rigorously evaluated.

The document primarily addresses the substantial equivalence of the new models (C10TX, C10RL, C10RLpro) to the existing predicate device (C10). The testing mentioned (battery capacity, pigment safety) relates to minor differences in appearance and battery capacity, not to the diagnostic performance or AI-related capabilities.

Therefore, many of your questions cannot be answered from the provided text. However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported diagnostic device performance (e.g., accuracy, sensitivity, specificity for specific pathologies). Instead, it focuses on demonstrating equivalence in technical parameters and safety standards to the predicate device. The "acceptance criteria" presented are implicitly met by showing substantial equivalence in the following areas:

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (as stated in comparison)
Clinical Characteristics:
Indications for Use	Identical to Predicate: Diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes for Fetal/Obstetrics, Gynecological, Abdominal, Urology (Convex); Small Parts, Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric (Linear); Cardiology, Cardiac Fetal Echo (Phase array). Transportable for use by healthcare professionals.
Intended patient population	Identical to Predicate: For use in all patients.
Intended use environment	Identical to Predicate: Hospital, clinics, home for use by healthcare professionals.
General Technological Characteristics:
Principle of operation	Identical to Predicate: Ultrasonic echo imaging using transducers to emit and receive ultrasonic waves, processing echoes to form images.
Design	Identical to Predicate: Autocorrelation for color processing, FFT for pulse Doppler processing, supporting Linear, Convex, and Phase array probes, Cine play back, Image file archive.
Operating Controls	Identical to Predicate: Convex: 90~~305mm, Linear: 20~~100mm, Cardiac: 90~160mm. Controls for Gain, Focus, Color box size/position, Baseline, Cline control (toggling freeze key).
Operation Mode	Identical to Predicate: B mode, B/M mode, Color Doppler mode, Pulse Wave mode.
Transducers	Identical to Predicate: Convex Array, Phase Array, Linear Array.
Frequency	Identical to Predicate: Convex 3.2MHz, Phase 2.5MHz, Linear 7.5MHz.
Probe connection to display unit	Identical to Predicate: Wireless connection via Wi-Fi.
Power source and requirement	Identical to Predicate: Rechargeable battery (Li-ion), DC 5V.
Device and Operating system for the software APP	Identical to Predicate: Commercial off-the-shelf Android device (COTS).
Acoustic output levels	Identical to Predicate: Track 3, Ispta.3 ≤ 720W/cm², MI ≤ 1.9, TI ≤ 6.0.
Safety and Effectiveness:
Patient contacting material	Evaluated according to ISO 10993-5 and ISO 10993-10 (Same as Predicate).
Electrical Safety	Evaluated according to IEC 60601-1 (Same as Predicate).
EMC	Evaluated according to IEC 60601-1-2 (Same as Predicate).
Performance Safety	Evaluated according to IEC 60601-2-37 (Same as Predicate).
Battery capacity, appearance (new models)	Tested and ensured to be qualified; safety tests conducted on pigments for skin contact.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Three new models are added in this submission (C10TX / C10RLpro). The new models have no difference in composition and performance parameters from the original model, only the appearance and battery capacity are different. We have tested two types of batteries with different capacities to ensure that they are both qualified. Different models of devices have different colors in appearance, and safety tests have been conducted on the pigments that form different colors to ensure that they can come into contact with human skin."

This implies the "testing" was primarily concerned with the new hardware variations (battery, appearance) and their safety, not a clinical performance study using patient data. Therefore, details about a "test set" in the context of diagnostic performance (sample size, data provenance) are not provided. This is common for a 510(k) if the changes are truly minor and do not impact core performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. The testing described is on hardware components (battery, pigments), not on diagnostic performance data requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. As above, no clinical test set for diagnostic performance requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This device is a "Pocket Ultrasound System" and the documentation does not mention any AI capabilities or human-in-the-loop studies. It describes a diagnostic ultrasound imaging system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. No indication of an AI algorithm being present or evaluated in standalone mode.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided. For a simple hardware change 510(k), clinical ground truth for diagnostic imaging is typically not required if substantial equivalence in performance is being claimed based on technical specifications and predicate performance.

8. The sample size for the training set

Not applicable/Not provided. The device does not appear to be an AI/ML device that requires a training set for model development.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, no training set for AI/ML is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

August 22, 2024

Beijing Konted Medical Technology Co.,Ltd % Xuexia Ren Official Correspondent (Chengdu Lizhu Technology Co., LTD) Room 111,1F, Building 3, No. 27 Yong Wang Road, Daxing Biological Pharmaceutical Base Daxing District, Beijing, 102629 PEOPLE'S REPUBLIC OF CHINA

Re: K241979

Trade/Device Name: Pocket Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code(s): IYN, IYO, ITX Dated: July 4, 2024 Received: July 5, 2024

Dear Xuexia Ren:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements. the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paramita Sengupta -2

For

Yanna Kang Assistant Director 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

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Indications for Use

510(k) Number (if known) K241979

Device Name Pocket Ultrasound System

Indications for Use (Describe)

Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Sum

I. SUBMITTER

Name: Beijing Konted Medical Technology Co., Ltd.

Address: Room 111,1F, Building 3, No. 27, Yong wang Road, Daxing Biological Pharmaceutical Industry Base, Daxing District, Beijing, 102629 PEOPLE'S REPUBLIC OF CHINA

Name of contact person: Deyi Zhu Tel: +86 10-60219113 Fax: +86 10-60219213 E-Mail: 3245132464@qq.com Submission date: 2024-07-02

II. Subject Device

Device trade name: Pocket Ultrasound System Model: C10, C10TX, C10RL, C10RLpro Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlation class: II Panel: Radiology Product code: IYN, IYO, ITX

III. Predicative Device

Submission Number: K231354 Device Trade Name: Pocket Ultrasound System (C10) Applicant: Beijing Konted Medical Technology Co., Ltd Regulation number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Requlation class: II Panel: Radiology Product code: IYN, IYO, ITX

IV. Device Description

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includes the ultrasound equipment and software application components. The ultrasound equipment is used to complete the ultrasonic imaging function and the software application components are used to complete the image display, measurement, patient information management as well as image storage etc. The Pocket Ultrasound System comprises a series of wireless transducers employing Wi-Fi-based technology to communicate with smartphone devices via direct Wi-Fi. One of the software application components is a software APP (MY USG), which is deployed on Android devices which supported Wi-Fi wireless communication. The software contained in the ultrasound equipment to control operation of the equipment and transfer images via Wi-Fi to the smartphone devices. This allows the user to export ultrasound images and display them across a range of portable personal devices. The communication protocol between the software APP and the other software contained in the equipment is specially defined for unique connection.

. A commercial off-the-shelf (COTS) Android smartphone/tablet device.
. the software application (MY USG) running as an App on the COTS device with Android system.
. The ultrasound equipment/Transducers: C10 / C10TX / C10RL / C10RLpro
- The 4 models have no difference in composition and performance parameters, only the appearance and battery capacity are different.
Accessory: Wireless Battery Charger & Power Adapter

V. Indication For Use

The Pocket Ultrasound System (Models: C10, C10TX, C10RLpro) is intended for diagnostic ultrasound imaging in B (2D), Color Doppler, Combined (B+M), and Pulsed Wave modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications depending on different configuration of array probes:

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Convex array probe - Fetal/Obstetrics, Gynecological, Abdominal, Urology

Linear array probe - Small Parts (breast, thyroid), Carotid, Peripheral Vessel, Muscular-Skeletal, Pediatric

Phase array probe - Cardiology, Cardiac Fetal Echo.

The Pocket Ultrasound System is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

VI. Comparison to predicate device and conclusion

The intended use, main materials, functional design, safety and performance characteristics of the subject device is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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Comparison in Detail(s):

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As can be seen from the above comparison table, there is no difference between subject device and predicate device in terms of technical parameters and they are essentially equivalent.

VII. Summary of Testing

Three new models are added in this submission (C10TX / C10RLpro). The new models have no difference in composition and performance parameters from the original model, only the appearance and battery capacity are different.

We have tested two types of batteries with different capacities to ensure that they are both qualified. Different models of devices have different colors in appearance, and safety tests have been conducted on the pigments that form different colors to ensure that they can come into contact with human skin.

IX. Conclusions

In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the subject device are substantially equivalent to the predicate device quoted above. The differences between the subject device and its predicat device do not introduce a new intended use and do no raise new issues of safety and effectiveness. Verification testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. It can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Elements ofComparison	Subject Device	Predicate Device	Discussion
Device Name	Pocket Ultrasound System	Pocket Ultrasound System (C10)	--
510(k) Number	K241979	K231354	--
Model	C10, C10TX, C10RL, C10RLpro	C10	--
Manufacture	Beijing Konted Medical TechnologyCo., Ltd	Beijing Konted Medical TechnologyCo., Ltd	Same
ClassificationName:	Ultrasonic pulsed doppler imagingsystem	Ultrasonic pulsed doppler imagingsystem	SE
DeviceClassification:	II	II	SE
Clinical characteristics
Indications forUse	The Pocket Ultrasound System isintended for diagnostic ultrasoundimaging in B (2D), Color Doppler,Combined (B+M), and Pulsed Wavemodes. It is indicated for diagnosticultrasound imaging and fluid flowanalysis in the following applicationsdepending on different configuration ofarray probes:	The Pocket Ultrasound System C10 isintended for diagnostic ultrasoundimaging in B (2D), Color Doppler,Combined (B+M), and Pulsed Wavemodes. It is indicated for diagnosticultrasound imaging and fluid flowanalysis in the following applicationsdepending on different configuration ofarray probes:	SE
Elements ofComparison	Subject Device	Predicate Device	Discussion
	Convex array probe - Fetal/Obstetrics,Gynecological, Abdominal, Urology	Convex array probe - Fetal/Obstetrics,Gynecological, Abdominal, Urology
	Linear array probe - Small Parts(breast, thyroid), Carotid, PeripheralVessel, Muscular-Skeletal, Pediatric	Linear array probe - Small Parts(breast, thyroid), Carotid, PeripheralVessel, Muscular-Skeletal, Pediatric
	Phase array probe - Cardiology,Cardiac Fetal Echo.	Phase array probe - Cardiology,Cardiac Fetal Echo.
	The Pocket Ultrasound System is atransportable ultrasound systemintended for use in environmentswhere healthcare is provided byhealthcare professionals.	The Pocket Ultrasound System C10 isa transportable ultrasound systemintended for use in environmentswhere healthcare is provided byhealthcare professionals.
Intended patientpopulation	For use in all patients	For use in all patients	SE
Intended useenvironment	Hospital, clinics, home for use byhealthcare professionals	Hospital, clinics, home for use byhealthcare professionals	SE
	General technological characteristics
	Principle of operation of the PocketUltrasound System is based onultrasonic echo imaging, which is acommon medical imaging technologyto use the transmission speed ofultrasound in different tissues andreflection degree	Principle of operation of the PocketUltrasound System is based onultrasonic echo imaging, which is acommon medical imaging technologyto use the transmission speed ofultrasound in different tissues andreflection degree
Working principle	differences, to get images throughcomputer processing for diagnosis andtreatment.	differences, to get images throughcomputer processing for diagnosis andtreatment.	SE
	The transducers inside the probe areresponsible to emitting and receivingultrasonic waves. When a pulse with acertain frequency and magnitude ontothe transducers, then ultrasonic wavesare generated through the inverse	The transducers inside the probe areresponsible to emitting and receivingultrasonic waves. When a pulse with acertain frequency and magnitude ontothe transducers, then ultrasonic wavesare generated through the inverse
	piezoelectric effect and transmitted tothe human body tissue through the	piezoelectric effect and transmitted tothe human body tissue through the
Elements ofComparison	Subject Device	Predicate Device	Discussion
	probe. When the ultrasonic wavemeets the tissue interface, it willgenerate echoes, which are scatteredin different tissues or blood flow andreceived by the probe and convertedinto electrical signals. The receiveramplifies and processes theseelectrical signals before transmittingthem to the processing unit. Based onthe signals received, the processingunit will calculate the intensity andtiming of the echoes to form an image.	probe. When the ultrasonic wavemeets the tissue interface, it willgenerate echoes, which are scatteredin different tissues or blood flow andreceived by the probe and convertedinto electrical signals. The receiveramplifies and processes theseelectrical signals before transmittingthem to the processing unit. Based onthe signals received, the processingunit will calculate the intensity andtiming of the echoes to form an image.
Design	Autocorrelation for color processingand FFT for pulse Doppler processing.Supporting Linear, Convex and Phasearray probes.Cine play back capability Image filearchive.	Autocorrelation for color processingand FFT for pulse Doppler processing.Supporting Linear, Convex and Phasearray probes.Cine play back capability Image filearchive.	SE
OperatingControls	Convex: 90~~305mmLinear: 20~~100mmCardiac: 90~160mm	Convex: 90~~305mmLinear: 20~~100mmCardiac: 90~160mm	SE
	Gain	Gain	SE
	Focus	Focus	SE
	Color box size/positive can be adjust	Color box size/positive can be adjust	SE
	Baseline	Baseline	SE
	Cline control: Toggling freeze key	Cline control: Toggling freeze key	SE
Operation Mode	B modeB/M modeColor Doppler modePulse Wave mode	B modeB/M modeColor Doppler modePulse Wave mode	SE
Elements ofComparison	Subject Device	Predicate Device	Discussion
Transducers	Convex Array; Phase Array; LinearArray	Convex Array; Phase Array; LinearArray	SE
Frequency	Convex Array: 3.2MHzPhase Array: 2.5MHzLinear Array: 7.5MHz	Convex Array: 3.2MHzPhase Array: 2.5MHzLinear Array: 7.5MHz	SE
Probe connectionto display unit	Wireless connection via Wi -Fi	Wireless connection via Wi -Fi	SE
Power sourc andpowerrequirement	Rechargeable battery(Li-ion)DC 5V	Rechargeable battery(Li-ion)DC 5V	SE
Device andOperating systemfor the softwareAPP	A commercial off-the-shelf Androiddevice (COTS)	A commercial off-the-shelf Androiddevice (COTS)	SE
Acoustic outputlevels	Track 3$Ispta.3≤720W/cm²$$MI≤1.9$$TI≤6.0$	Track 3$Ispta.3≤720W/cm²$$MI≤1.9$$TI≤6.0$	SE
Safety and Effectiveness
Patient contactingmaterial	Per ISO 10993-5 and ISO 10993-10	Per ISO 10993-5 and ISO 10993-10	SE
Electrical Safety	Evaluated according to IEC 60601-1	Evaluated according to IEC 60601-1	SE
EMC	Evaluated according to IEC 60601-1-2	Evaluated according to IEC 60601-1-2	SE
PerformanceSafety	Evaluated according to IEC 60601-2-37	Evaluated according to IEC 60601-2-37	SE