Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

K241554 · Telefield Medical Imaging (Shenzhen) Limited · IYN · Oct 24, 2024 · Radiology

Device Facts

• Record ID: K241554
• Device Name: Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
• Applicant: Telefield Medical Imaging (Shenzhen) Limited
• Product Code: IYN · Radiology
• Decision Date: Oct 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes. It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid. The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals.

Device Story

Portable, software-controlled ultrasound system; consists of handheld main unit. Inputs: ultrasonic signals captured via linear or convex array transducers. Processing: real-time transformation of acoustic data into B-mode (2D), Color Doppler, and Pulsed Wave imaging modes. Output: real-time ultrasound images, blood flow patterns, and anatomical measurements (distance, trace, depth, angle, circumference, velocity) displayed on screen. Used in point-of-care settings by qualified healthcare professionals. Healthcare providers use visual output for anatomical visualization and hemodynamic assessment to inform clinical decision-making. Benefits include convenient, portable diagnostic imaging for various clinical applications.

Clinical Evidence

Bench testing only. Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62359, NEMA UD 3, and IEC 62304 standards demonstrated safety and performance equivalence.

Technological Characteristics

Handheld ultrasound system; materials: ABS, Silicone. Transducer types: Linear and Convex arrays. Power: DC 5V. Connectivity: Software-controlled with image storage/review/printing. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, NEMA UD 3. Software lifecycle: IEC 62304 compliant.

Indications for Use

Indicated for ultrasound imaging and fluid flow analysis in abdominal, small organ, musculoskeletal, peripheral vessel, urology, and carotid applications. Intended for use by trained healthcare professionals in clinical environments.

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

• DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems (K150204)

Reference Devices

• minisono (K182845)
• Digital Color Doppler Palm Ultrasound System (SonoEye P2) (K201967)

Submission Summary (Full Text)

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Telefield Medical Imaging (Shenzhen) Limited Dolly Xiong Regulatory Affairs Manager Room A614-A619, A701-A703, National Key Lab Platform Building No.1 Yuexing Second Road, Hi-tech Industrial Park, Nanshan Dist Shenzhen, Guangdong 518054 CHINA

Re: K241554

Trade/Device Name: Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN. IYO. ITX Dated: May 10, 2024 Received: May 31, 2024

Dear Dolly Xiong:

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.

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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).

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 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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 S. KANG -S

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) K241554

Device Name

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

Indications for Use (Describe)

The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes.

It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid.

The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified 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) Summary

[As required by 21 CFR 807.92]

#### 510(k) Number: K241554 Date: May 10th, 2024 Type of 510(k) Submission: Traditional 510(k) Basis for 510(k) Submission: New device Submitter: Telefield Medical Imaging (Shenzhen) Limited Room A614-A619, A701-A703, National Key Lab Platform Building, No.1 Yuexing Second Road, Hi-tech Industrial Park, Nanshan District, Shenzhen, Guangdong, People's Republic of China Tel: [phone] Fax: [phone] E-mail: [e-mail] Contactor: Dolly Xiong Regulatory Affairs Manager E-mail: [e-mail] Tel: [phone] Fax: [phone]. Device Description Device Name: Portable Digital Color Doppler Ultrasound System SCN201D, SCN201L Model Name: Classification Name: Ultrasonic pulsed doppler imaging system Product Code: IYN, IYO, ITX Device Class: 2 Regulation Number: 21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570 Review Panel: Radiology Indications for use: The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes. It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid. The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals. Device Description: The Portable Digital Color Doppler Ultrasound System is a portable, general-purpose, software-controlled ultrasound system. It consists of a handheld ultrasound main unit and software. The system is engineered to produce real-time ultrasound images, with an emphasis on capturing detailed anatomical structures and evaluating blood flow patterns using

#### 1. Submission Information

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color Doppler technology. It includes features for measurements, image storage and review, as well as printing and recording capabilities. This portable system enables point-of-care ultrasound applications, providing healthcare professionals with a convenient way to visualize anatomical structures and assess blood flow dynamics.

| | Primary Predicate Device | Reference Device 1 | Reference Device 2 |
|-----------------------------|----------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------|
| 510(k) Number | K150204 | K182845 | K201967 |
| Marketing<br>Clearance Date | 04/10/2015 | 12/27/2018 | 02/26/2021 |
| Product Name | DC-70/DC-70T/DC-70<br>PRO/DC-70 EXP Diagnostic<br>Ultrasound Systems | minisono | Digital Color Doppler<br>Palm Ultrasound System<br>(SonoEye P2) |
| Manufacturer | Shenzhen Mindray<br>Bio-medical Electronics Co.,<br>LTD | ALPINION MEDICAL<br>SYSTEMS Co., Ltd. | CHISON Medical<br>Technologies Co., Ltd. |

### 3. Predicate Devices Identification

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# 4. Substantially Equivalent Comparison

| Parameters | Proposed Device | Primary Predicate Device | Reference device 1 | Reference device 2 | Remark |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Number | K241554 | K150204 | K182845 | K201967 | -- |
| Marketing<br>clearance date | No | April 10, 2015 | December 27, 2018 | February 26, 2021 | -- |
| Device Name | Portable Digital Color Doppler Ultrasound System | DC-70/DC-70T/DC-70<br>PRO/DC-70 EXP Diagnostic<br>Ultrasound Systems | minisono | Digital Color Doppler Palm<br>Ultrasound System | -- |
| Model Name | SCN201D, SCN201L | DC-70/DC-70T/DC-70<br>PRO/DC-70 EXP | minisono L3-12, minisono C1-6 | SonoEye P2 | -- |
| 510(k) Owner | Telefield Medical Imaging<br>(Shenzhen) Limited | Shenzhen Mindray Bio-medical<br>Electronics Co., LTD | ALPINION MEDICAL<br>SYSTEMS Co., Ltd. | CHISON Medical Technologies<br>Co., Ltd. | -- |
| Regulation<br>Number | 21 CFR 892.1550, 21 CFR<br>892.1560, 21 CFR 892.1570 | 21 CFR 892.1550, 21 CFR<br>892.1560, 21 CFR 892.1570, 21<br>CFR 892.2050 | 21 CFR 892.1550, 21 CFR<br>892.1560, 21 CFR 892.1570 | 21 CFR 892.1550, 21 CFR<br>892.1560, 21 CFR 892.1570 | Same |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX, LLZ | IYN, IYO, ITX | IYN, IYO, ITX | Same |
| Device Class | 2 | 2 | 2 | 2 | Same |
| Review Panel | Radiology | Radiology | Radiology | Radiology | Same |
| Intended use | The Portable Digital Color<br>Doppler Ultrasound System is<br>intended for ultrasound imaging in<br>B (2D), Color Doppler and Pulsed<br>Wave imaging modes. | DC-70/DC-70T /DC-70<br>PRO/DC-70 EXP Diagnostic<br>Ultrasound System is applicable<br>for adults, pregnant women,<br>pediatric patients and neonates. It<br>is intended for use in fetal | The device is intended for use by a<br>qualified physician for the<br>evaluation of soft tissue and blood<br>flow in the clinical applications;<br>Fetal; Abdominal; Pediatric, Small<br>Organ (breast, testes, thyroid) | The Digital Color Doppler Palm<br>Ultrasound System is intended for<br>diagnostic ultrasound imaging in<br>B (2D), B/M, Color Doppler,<br>Combined(B+Color), Pulsed Wave<br>and Fusion Harmonic Imaging | Similar |
| | imaging and fluid flow analysis in<br>the following applications:<br>Abdominal,<br>Small Organ,<br>Musculoskeletal,<br>Peripheral Vessel, Urology, and Carotid.<br>The Portable Digital Color<br>Doppler Ultrasound System is<br>intended for use in environments<br>where healthcare is provided by<br>appropriately trained and qualified<br>healthcare professionals. | abdominal, pediatric, small<br>organ(breast, thyroid, testes),<br>neonatal and adult cephalic,<br>trans-rectal, trans-vaginal,<br>musculo-skeletal(conventional,<br>superficial), adult and pediatric<br>cardiac, peripheral vessel and<br>urology exams. | Musculo-skeletal (Conventional);<br>Musculo-skeletal (Superficial);<br>Peripheral Vascular (PV); and<br>Urology (including prostate). | modes. It is indicated for<br>diagnostic ultrasound imaging and<br>fluid flow analysis in the<br>following applications: Pediatrics,<br>Small Organ, Musculoskeletal,<br>Peripheral Vessel, Carotid.<br>The Digital Color Doppler Palm<br>Ultrasound System is intended for<br>use in environments where<br>healthcare is provided by<br>healthcare professionals. | |
| Type of use | Prescription Use | Prescription Use | Prescription Use | Prescription Use | Same |
| Operation Mode | B (2D) mode<br>Color Doppler mode<br>Pulsed Wave mode | B-Mode, M-Mode, PW-Mode,<br>CW-Mode, Color-Mode,<br>Power/Dirpower Mode, THI or the<br>combined mode (B/M-Mode,<br>B/PW-mode, B/PW/Color) | B mode<br>M mode<br>PWD mode<br>Color Doppler<br>Power Doppler<br>Tissue Harmonic Imaging<br>Combined (B/Color Doppler,<br>B/PWD, B/Color Doppler/PWD) | B (2D) mode<br>B/M mode<br>Color Doppler mode<br>Combined (B+Color)mode<br>Pulsed Wave mode<br>Fusion Harmonic Imaging modes | Similar |
| Application area | Abdominal<br>Small Organ<br>Musculoskeletal<br>Peripheral Vessel<br>Carotid | Fetal, abdominal, pediatric, small<br>organ, neonatal and adult cephalic,<br>trans-rectal, trans-vaginal,<br>musculo-skeletal (conventional,<br>superficial), adult and pediatric | Fetal<br>Abdominal<br>Pediatric<br>Small Organ<br>Musculo-skeletal | Pediatrics<br>Small Organ<br>Musculoskeletal<br>Peripheral Vessel<br>Carotid | Similar |
| | Urology | cardiac, peripheral vessel and<br>urology | Peripheral Vascular (PV)<br>Urology | | |
| Transducer Types | Linear array<br>Convex Array | Linear array<br>Convex Array | Linear array<br>Convex Array | Linear array | Same |
| Intended user | Healthcare professionals | Healthcare professionals | Healthcare professionals | Healthcare professionals | Same |
| Applied<br>environment | Environments where healthcare is<br>provided by healthcare<br>professionals | Environments where healthcare is<br>provided by healthcare<br>professionals | Environments where healthcare is<br>provided by healthcare<br>professionals | Environments where healthcare is<br>provided by healthcare<br>professionals | Same |
| Acoustic Output<br>Track | Track 3 | Track 3 | Track 3 | Track 3 | Same |
| Measurements | B (2D) mode: Distance, Trace,<br>Depth, Angle, Circumference,<br>Area<br>Doppler mode: Velocity | 2D mode: Distance, Area, Angle,<br>Volume, Trace Area,<br>Circumference, Heart Rate,<br>Volume<br>Doppler mode: Velocity, Time | 2D mode: Distance, Ellipse,<br>Trace, %Stenosis, Volume<br>M mode: Distance,<br>Time, %Stenosis<br>Doppler mode: Velocity, Time | 2D mode: Depth, Distance, Area,<br>Volume<br>Doppler mode: D Velocity, Time<br>B/M mode: Distance, Time, HR | Similar |
| Design | Handheld | Floor Standing | Handheld | Handheld | Similar |
| Power supply | DC 5V | 100-127V ~ or 220-240 V ~<br>50/60Hz | DC 5V | DC 5V | Similar |
| Operating<br>environment | Ambient temperature: 5°C ~ 40°C<br>Relative humidity: 30% ~ 85%<br>(No condensation)<br>Atmospheric pressure: 80kPa ~<br>106kPa | Temperature: 0°C~40°C<br>Relative humidity: 30%~85% (no<br>condensation)<br>Atmospheric pressure:<br>700hPa~1060hPa | Temperature: 10-35°C;<br>Relative humidity: 30-75%;<br>Barometric pressure: 700 to 1060<br>hPa | Temperature: 10-38°C;<br>Relative humidity: 30-75%;<br>Barometric pressure: 700 to 1060<br>hPa | Similar |
| Transportation & | Ambient temperature: -20°C ~ | Temperature: -20°C~55°C | Temperature: -25-60°C; | Temperature: -10-50°C; | |
| Storage<br>environment | | Relative humidity: 20%~95% (no<br>condensation)<br>Atmospheric pressure:<br>700hPa~1060hPa | Relative humidity: 20-90%<br>Barometric pressure: 700 to 1060<br>hPa | Relative humidity: ≤80%,<br>non-condensing;<br>Barometric pressure: 700 to 1060<br>hPa | |
| | 55°C<br>Relative humidity: 15% ~ 95%<br>(No condensation)<br>Atmospheric pressure: 80kPa ~<br>106kPa | | | | |
| Weight | SCN201D: 500g<br>SCN201L: 450g | <85kg | minisono L3-12: 175g<br>minisono C1-6: 180g | 200g | |
| Dimensions | SCN201D:<br>182mm×97mm×177mm<br>SCN201L:<br>167mm×71mm×176mm | 855±5mm(Length)×510±5mm<br>(Width) × 1190±5mm (Height) | minisono L3-12:<br>150mm×62.5mm×25.5mm<br>minisono C1-6:<br>157mm×62.5mm×25.5mm | 64mm×170mm×24mm | Similar |
| Materials | ABS, Silicone | Unpublished | Unpublished | Unpublished | Similar |
| Compliant<br>standards | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC /TR 60601-4-2<br>IEC 60601-1-6<br>IEC 62366-1<br>IEC 60601-2-37<br>IEC 62359<br>NEMA UD 3 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 62366<br>IEC 60601-2-37<br>NEMA UD 2 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-2-37<br>ISO 10993-1<br>AIUM/NEMA UD 2 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-2-37<br>ISO 10993-1 | Similar |
| Positioning<br>system | Optical positioning system | Magnetic navigator positioning<br>system | Unpublished | Unpublished | Similar |
| Labeling | Meet the FDA requirements | Meet the FDA requirements | Meet the FDA requirements | Meet the FDA requirements | Same |

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The proposed devices have the similar indication for use as well as comparable technical and performance properties and the minor differences don't raise any additional questions on effectiveness. Therefore, the proposed devices are substantially equivalent to the predicate devices.

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### 5. Non-clinical Testing Summary

The Portable Digital Color Doppler Ultrasound System has passed testings according to:

1) ANSI AAM ES60601-1:2005/R12012 & A1:2010/R)2012 & A2:2010/RJ2012 (Cons. Text) Incl. AMD2:2021), Medical electrical equipment - Part 1: Geneal requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]:

2) IEC 6661-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical coupments for basic safety and essertail performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests;

3) IEC TR 60601-4-2 Editor 1.0 2016-05, Medical equipment - Part 4-2: Guidance and interpretation - Electromagencie immunity performance of medical clectrical equipment and medical electrical systems;

4) IEC 60601-1-6 Editor 3.2 2020-07 CONSOLDATED VERSION. Medical electrical coursent - Part 1-6: Galety and esserial performance-Collateral standard: Usability;

5) IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices;

6) IEC 6601-2-37 Edition 2.1 2015, Medical electrical equirements for the basic safety and essental performance of ultraonic medical diagnostic and monitoring equipment;

7) IEC 623.9 Edition 2.1 2017-09 CONSOLIDATED VERSION, Ultrasoniss - Field characterization - Test methods for the mall nechanical indices related to medical diagnostic ultrasonic fields;

8) NEMA UD 3-2004 (R2009), Standard for Real-Time Display of Thermal and Mechanical Acoustic Ultrasound Fourprent;

9) IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software life cycle processes.

## 6. Conclusion

The enclusion drawn the nonelinical tests demontates that the subject device in 510(k) submission, the Portable Digital Color Doppler Ultrasound System, is as safe, as effective, and performs as well as the legally marketed predicate devices.