Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a general use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.

Device Description

The Digital Ultrasonic Diagnostic Imaging System is designed to be portable notebook ultrasound systems and mainly include the ultrasound equipment, transducer and adapter. The equipment to complete the ultrasonic imaging function, host completes the image display, measurement, patient information, image storage, and other applications Standard keyboards, touch panels, and buttons, as well as multifunctional editors, mainly control device operations. The display screen is used to display work interfaces, images, and parameters. Different interfaces are used to connect transducers, other devices, or power supplies. There are four different types of transducers, namely large convex, linear array, Micro convex, Intracavity, the frequency scope of different transducers is from 2.5MHz to 11MHz. The system provides a variety of modes for flexibly selecting, which include B-mode, M-mode, Color-mode, Power-mode, PW-mode, and combined modes (i.e., B/M- mode). Real time image and dynamic changes of tissues, organs or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line. The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Digital Ultrasonic Diagnostic Imaging System (Model: F6). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them in the way a clinical trial or performance study report would.

However, based on the information provided, here's what can be extracted and inferred:

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

The document doesn't present a formal table of acceptance criteria and reported device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that the acceptance criteria are met if the device's technical characteristics and performance are comparable or don't raise new safety/effectiveness concerns.

The "Test Summary" section (6.1 Summary of Non-Clinical Tests) lists various international and FDA guidance standards that the device has been evaluated against. Meeting these standards is an implicit "acceptance criterion" for safety, electromagnetic compatibility, and basic performance.

Acceptance Criteria (Inferred from Standards)	Reported Device Performance
Safety and Essential Performance:
IEC 60601-1 Ed 3.2 2020-08 (General requirements for basic safety and essential performance)	Evaluated and presumably met
IEC 60601-1-2 Ed 4.1 2020-09 (Electromagnetic disturbances)	Evaluated and presumably met
IEC 60601-2-37 Ed 2.1 2015 (Ultrasonic medical diagnostic and monitoring equipment)	Evaluated and presumably met
IEC 62133-2 Ed 1.0 2017-02 (Safety requirements for lithium systems)	Evaluated and presumably met
Biocompatibility:
ISO 10993-5 2009-06-01 (Tests for in vitro cytotoxicity)	Evaluated and presumably met
ISO 10993-10 2021-11 (Tests for skin sensitization)	Evaluated and presumably met
ISO 10993-23 2021-01 (Tests for irritation)	Evaluated and presumably met
Acoustic Output:
FDA Guidance: "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (Feb 21, 2023) - Track 3	SPTA max=720 mw/cm², MI max =1.9, MI display, TI display (These values are the performance and are compared to the predicate's values)
Software Functions:
FDA Guidance: "Content of Premarket Submissions for Device Software Functions" (June 14, 2023)	Evaluated and presumably met
Clinical Accuracy Performance:
FDA Guidance: "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (Feb 21, 2023) - Clinical accuracy performance	Evaluated and presumably met via non-clinical tests (as no clinical study was included)

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 explicitly states: "No clinical study is included in this submission." Therefore, there is no information about a test set sample size or its provenance in terms of patient data. The "tests" mentioned are non-clinical (bench testing) against standards.

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)

Since there was no clinical study, there is no mention of experts establishing ground truth for a test set.

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

Not applicable as there was no clinical test set.

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. The device is a "Digital Ultrasonic Diagnostic Imaging System," which is a standalone imaging device, not an AI-assisted diagnostic tool that would involve human readers and comparative effectiveness studies.

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

This question typically applies to AI/software as a medical device. The device in question is a diagnostic ultrasound system. Its performance is assessed through its ability to generate images, measure, display, and analyze fluid flow, which is its inherent standalone function. The non-clinical tests listed serve to prove its performance in this standalone capacity by meeting established safety and performance standards relevant to ultrasound technology.

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

For the non-clinical tests, the "ground truth" would be the specifications and requirements outlined in the referenced standards (e.g., specific acoustic output limits, cytotoxicity thresholds, electromagnetic compatibility levels).

8. The sample size for the training set

Not applicable. This device is a diagnostic ultrasound system, not an AI/machine learning model that typically requires a training set of data.

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

Not applicable, as it's not an AI/ML device.

Summary

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March 22, 2024

Image /page/0/Picture/11 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

GuangDong Youkey Medical Co., Ltd. % Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District. Guangzhou CHINA

Re: K231930

Trade/Device Name: Digital Ultrasonic Diagnostic Imaging System (Model: F6) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 27, 2024 Received: February 27, 2024

Dear Cassie Lee:

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/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.

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 (QS) 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marjan Nabili -S

for

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

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Indications for Use

510(k) Number (if known) K231930

Device Name

Digital Ultrasonic Diagnostic Imaging System

Indications for Use (Describe)

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)

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510(k) Summary for K231930

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: GuangDong Youkey Medical Co., Ltd. Establishment Registration Number: 3025429169 Address: Unit 601, 6/F, Block B, Building 1, B1 District, Hantian Technology City, Dongping Road, Pingxi Shanghai Village, Guicheng Street, Nanhai District, Foshan City, Guangdong Province, China Tel: +(86)18971511819 Contact Person: Hu Zeyi E-mail: 2605171549@qq.com

Application Correspondent:

Contact Person: Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446

Date of the summary prepared: 3/22/2024

2. Subject Device Information

E-mail: 382198657@gq.com

Type of 510(k): Traditional

Trade Name: Digital Ultrasonic Diagnostic Imaging System

Model: F6

Common Name: Diagnostic Ultrasound System and Transducer

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Classification name: Ultrasonic Pulsed Doppler Imaging System Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550

3. Predicate Device Information

Primary Predicate Device:

Sponsor: GuangDong Youkey Medical Co., Ltd. Trade Name: Pocket Ultrasound System Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K211746 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550 Reference Device 1: Sponsor: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Trade Name: M5 DIAGNOSTIC ULTRASOUND SYSTEM Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K102991 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550 Reference Device 2: Sponsor: Healcerion Co., Ltd.

Trade Name: SONON Ultrasound Imaging System (Model: SONON 300C)

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Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K151339 Review Panel: Radiology Product Code: IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1560 Reference Device 3 Sponsor: Healcerion Co., Ltd Trade Name: SONON Ultrasound Imaging System (Model: 300L) Common Name: Diagnostic Ultrasound System and Transducer Classification name: Ultrasonic Pulsed Doppler Imaging System 510(K) Number: K170085 Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Class: II Regulation Number: 21 CFR 892.1550

4. Device Description

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image and dynamic changes of tissues, orqans or vessels will be showed in the image under B-mode, while coloring blood flow can be seen under Color-mode, PW-mode or Power-mode. M-mode is defined as time motion display of the ultrasound wave along a chosen ultrasound line.

The system not only provides real-time tissues, organs or blood flow images, but also contains measurement of anatomical structures and analysis packages, which can offer diagnosticians detailed and useful information.

5. Intended Use / Indications for Use

Digital Ultrasonic Diagnostic Imaging System (Model: F6) is a qeneral use ultrasound device intended for use by appropriately qualified and trained healthcare professionals for ultrasound imaging, measurement, display and fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid, etc.), Peripheral Vascular, Urology. Modes of operation include B mode, M mode, Color Doppler, Power Doppler, PWD and Combined (B+M; B+CD; B+PWD). This system is suitable for use in hospital and clinical settings.

6. Test Summary

6.1 Summary of Non-Clinical Tests

Digital Ultrasonic Diagnostic Imaging System has been evaluated the safety and performance by lab bench testing as following:

A IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

A IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

♪ IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and

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essential performance of ultrasonic medical diagnostic and monitoring equipment

A IEC 62133-2 Edition1.0 2017-02
Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 First edition 2021-01

Biological evaluation of medical devices - Part 23: Tests for irritation

A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Acoustic Output Test per FDA Guidance for Track 3
"Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff", June 14, 2023
A "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff", February 21, 2023: Clinical accuracy performance
6.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

7. Comparison to predicate device

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Digital Ultrasonic Diagnostic Imaging System 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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Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
Manufacturer	GuangDong YoukeyMedical Co., Ltd.	GuangDong YoukeyMedical Co., Ltd.	SHENZHENMINDRAYBIO-MEDICALELECTRONICS CO.,LTD	Healcerion Co., Ltd.	Healcerion Co., Ltd.	--
Trade Nameand model	Digital UltrasonicDiagnostic Imaging System(model: F6)	Pocket UltrasoundSystem (model:P50,P51,P52,P53,P54,P55,P56)	M5 DIAGNOSTICULTRASOUNDSYSTEM	SONON UltrasoundImaging System(model: 300C)	SONON UltrasoundImaging System(model: 300L)	--
510(k) Number	K231930	K211746	K102991	K151339	K170085	--
Classification, Indications for Use and Intended Use
ClassificationProductCode	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX	IYO, ITX	IYN, IYO, ITX	Same
Indications for	Digital Ultrasonic	Pocket Ultrasound	The M5 Diagnostic	The SONON	The SONON	Same
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
Use	Diagnostic Imaging System(Model: F6) is a generaluse ultrasound deviceintended for use byappropriately qualified andtrained healthcareprofessionals for ultrasoundimaging, measurement,display and fluid flowanalysis of the humanbody. Specific clinicalapplications and examtypes include: Abdominal,Obstetrics, Gynaecology,Small Parts (breast,	System(Model:P50,P51,P52,P53,P54,P55,P56) isintended for use by anappropriately trained,qualified physician forultrasound evaluation.Specific clinicalapplications and examtypes include:Abdominal, Obstetrics,Gynaecology, SmallParts (breast, thyroid,etc), PeripheralVascular, Urology. This	Ultrasound System isapplicable for adults,pregnant women,pediatric patients andneonates. It isintended for- use inabdomen,gynecology,obstetrics, smallparts (breast, testes,thyroid, etc.),pediatrics,transcranial, cardiac,peripheralvascular, urology,	Ultrasound ImagingSystem (Model:SONON 300C) isintended for diagnosticultrasound echoimaging,measurement, andanalysis of the humanbody for generalclinical applicationsincluding obstetrics(OB), gynecology (GY)and general(abdominal) imaging.	Ultrasound ImagingSystem (Model: 300L)is intended fordiagnostic ultrasoundecho imaging,measurement, andanalysis of the humanbody for generalclinical applicationsincludingmusculoskeletal(MSK), vascular, smallparts (breast, thyroid),and thoracic/pleuralmotion and fluid
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
	thyroid, etc.), PeripheralVascular, Urology. Modesof operation include Bmode, M mode, ColorDoppler, Power Doppler,PWD and Combined (B+M;B+CD; B+PD; B+PWD).This system is suitable foruse in hospital and clinicalsettings.	system is suitable foruse in hospital andclinical settings.	orthopedics,intracoperative andmusculoskeletal(general andsuperficial) exams.		detection imaging.
Technological Characteristics
Portability	Portable ultrasound system	Portable ultrasoundsystem	Portable ultrasoundsystem	Portable ultrasoundsystem	Portable ultrasoundsystem	Same
Duration of Use	Limited (<24 hours)	Limited (<24 hours)	Limited (<24 hours)	Limited (<24 hours)	Limited (<24 hours)	Same
Transducer	Convex Array	Convex Array	linear array, convex	Convex	Linear	Same
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
Types	Linear ArrayIntracavity	Linear ArrayPhased ArrayIntracavity	array and phasedarray
Frequency	2.5-11.0 MHz	3.5-7.5MHz	2.0-12.0 MHz	Convex, 3.5 MHzfrequency	Linear, 5MHz / 7.5MHz/ 10MHz frequency	SimilarNote 1
Environment ofUse	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Hospital, clinic, andmedical office settings	Same
Power Source	Power adapter: Input AC100~240V/60Hz 0.9A;Output DC 15V 2.4AInternal power supply: DC11.1V 8400mAh (Li-ion)	Removable battery(Li-ion)	110V-120V	Battery (Li-ion)	Battery (Li-ion)	DifferentNote 2
WirelessCapability	Not applicable	Communicateswirelessly via Wi-Fi	Not applicable	Wireless	Wireless	Same
Acoustic Output	SPTA max=720 mw/cm²	ISPTA max=720	SPTA max=720	ISPTA.3 = 0.0627	Below Track 3 FDA	Same
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
Levels	MI max =1.9MI displayTI display	mw/cm²MI max =1.9MI displayTI display	mw/cm²MI max =1.9MI displayTI display	W/cm2MI = 0.7861TIS = 0.2535Ipa.3@MI.max =11.6369 W/cm2	limits in accordancewith Sept. 2008ultrasound systemsguidance document
ImagingCapacities	B modeM modeColor DopplerPower DopplerPWD and Combined (B+M;B+CD; B+PD; B+PWD)	B modeM modeColor DopplerPower DopplerPWD and Combined(B+M; B+CD; B+PD;B+PWD)	B modeM modeColor DopplerPower DopplerPWD and Combined(B+M; B+CD; B+PD;B+PWD,B+CD+PWD,PD+PW+B)	Pulsed-echoultrasoundMode B (2D) scan	Pulsed-echo andDopplerultrasoundMode B (2D), Colorscan	Same
Patient	For use in all patients	For use in all patients	For use in all patients	For use in all patients	For use in all patients	Same
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
Population
Users	Healthcare professionals	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals	Healthcareprofessionals	Same
Image DisplayUnit	Display screen	Windows environment(13.3 inches)Android environment(9.6 inches)	Display screen	Mobile device (4 to 10inches approximately)	Mobile device (4 to 10inches approximately)	Same
ProbeConnection toDisplay	Wired	Wireless	Wired	Wireless	Wireless	Same
Off-the-shelfoperatingsystem	Android	Windows /Android	Not published	iOS / Android	iOS / Android	Same
Software	Embedded software	Run as an app on off-theshelf mobile device	Embedded software	Runs as an app onoff-the-shelf mobile	Runs as an app onoff-the-shelf mobile	Same
Elements ofComparison	Subject Device	Primary PredicateDevice	Reference Device 1	Reference Device 2	Reference Device 3	Verdict
				device	device
Material
Patient contactmaterials	All types Transducer:Shell: PC+ABS;Acoustic lens: Silicone	All types Transducer:Shell: PC+ABS;Acoustic lens: Silicone	Not published	All patient-contactmaterials arebiocompatible and canbe disinfected	All patient-contactmaterials arebiocompatible and canbe disinfected	Same
Contact area	Intact skin and mucousmembranes	Intact skin and mucousmembranes	Intact skin andmucous membranes	Not published	Not published	Same

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Comparison in Detail(s):

Note 1:

Although the "Frequency" of the subject device is different from the predicate device, the frequency range of the subject device is within the range of the predicate device K102991 So, the slight difference will not affect the safety and effectiveness of the subject device.

Note 2:

Although the "Power Source" of the subject device is different from the predicate device, it meets the requirements of safety and performance standards IEC 60601-1and IEC 62133-2. So, the differences between the predicate device and the subject device will not affect the safety and effectiveness of the subject device.

8. Final Conclusion:

The subject device Digital Ultrasonic Diagnostic Imaging System has all features of the primary predicate device (K211746). The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the primary predicate device (K211746).

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.