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 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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L). The information provided focuses on demonstrating substantial equivalence to already-cleared predicate devices, rather than presenting a standalone study with specific performance acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth are not available within this document. The submission primarily relies on non-clinical testing to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) like you would find in a clinical study report for an AI/algorithm-driven device.

Instead, the "acceptance criteria" here are implied by compliance with recognized standards and the demonstration of equivalent technical and performance properties to predicate devices. The document essentially states that the device "passed testings according to" various standards (listed below) and that "the proposed devices are substantially equivalent to the predicate devices" because "the minor differences don't raise any additional questions on effectiveness."

Therefore, a table of specific acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity) cannot be generated from the provided text. The document focuses on showing compliance with general safety and performance standards for ultrasound systems.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. This document details non-clinical testing for compliance with standards, not a clinical test set with specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a test set is described in this document. The testing described is primarily non-clinical compliance testing.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method for a test set 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

No. A MRMC comparative effectiveness study is not mentioned or implied. This device is an ultrasound system, not an AI or algorithm-assistance tool for human readers in the context of diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an ultrasound system, not a standalone algorithm/AI for diagnostic interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The document describes non-clinical testing against established engineering and safety standards for ultrasound devices, not against a clinical ground truth for diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device is an ultrasound imaging system, not an AI/algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set is mentioned, the method for establishing ground truth for a training set is not applicable.

Summary of Available Information from the Document:

The document emphasizes non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety and general performance in accordance with recognized standards.

Non-clinical Testing Summary (from Section 5 of the 510(k) Summary):

The Portable Digital Color Doppler Ultrasound System has passed testing according to the following standards:

ANSI AAMI ES60601-1:2005/R12012 & A1:2010/R)2012 & A2:2010/RJ2012 (Cons. Text) Incl. AMD2:2021): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC TR 60601-4-2 Editor 1.0 2016-05: Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity performance of medical electrical equipment and medical electrical systems.
IEC 60601-1-6 Editor 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: Safety and essential performance - Collateral standard: Usability.
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices.
IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION: Ultrasonics - Field characterization - Test methods for the measurement of mechanical indices related to medical diagnostic ultrasonic fields.
NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output for Diagnostic Ultrasound Equipment.
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software life cycle processes.

Conclusion stated: The non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 86-755-83566313 Fax: 86-755-83571649 E-mail: info@scolioscan.com Contactor: Dolly Xiong Regulatory Affairs Manager E-mail: dolly.xiong@scolioscan.com Tel: 86-755-83566313 Fax: 86-755-83571649 2. 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
MarketingClearance Date	04/10/2015	12/27/2018	02/26/2021
Product Name	DC-70/DC-70T/DC-70PRO/DC-70 EXP DiagnosticUltrasound Systems	minisono	Digital Color DopplerPalm Ultrasound System(SonoEye P2)
Manufacturer	Shenzhen MindrayBio-medical Electronics Co.,LTD	ALPINION MEDICALSYSTEMS Co., Ltd.	CHISON MedicalTechnologies 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	--
Marketingclearance date	No	April 10, 2015	December 27, 2018	February 26, 2021	--
Device Name	Portable Digital Color Doppler Ultrasound System	DC-70/DC-70T/DC-70PRO/DC-70 EXP DiagnosticUltrasound Systems	minisono	Digital Color Doppler PalmUltrasound System	--
Model Name	SCN201D, SCN201L	DC-70/DC-70T/DC-70PRO/DC-70 EXP	minisono L3-12, minisono C1-6	SonoEye P2	--
510(k) Owner	Telefield Medical Imaging(Shenzhen) Limited	Shenzhen Mindray Bio-medicalElectronics Co., LTD	ALPINION MEDICALSYSTEMS Co., Ltd.	CHISON Medical TechnologiesCo., Ltd.	--
RegulationNumber	21 CFR 892.1550, 21 CFR892.1560, 21 CFR 892.1570	21 CFR 892.1550, 21 CFR892.1560, 21 CFR 892.1570, 21CFR 892.2050	21 CFR 892.1550, 21 CFR892.1560, 21 CFR 892.1570	21 CFR 892.1550, 21 CFR892.1560, 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 ColorDoppler Ultrasound System isintended for ultrasound imaging inB (2D), Color Doppler and PulsedWave imaging modes.	DC-70/DC-70T /DC-70PRO/DC-70 EXP DiagnosticUltrasound System is applicablefor adults, pregnant women,pediatric patients and neonates. Itis intended for use in fetal	The device is intended for use by aqualified physician for theevaluation of soft tissue and bloodflow in the clinical applications;Fetal; Abdominal; Pediatric, SmallOrgan (breast, testes, thyroid)	The Digital Color Doppler PalmUltrasound System is intended fordiagnostic ultrasound imaging inB (2D), B/M, Color Doppler,Combined(B+Color), Pulsed Waveand Fusion Harmonic Imaging	Similar
	imaging and fluid flow analysis inthe following applications:Abdominal,Small Organ,Musculoskeletal,Peripheral Vessel, Urology, and Carotid.The Portable Digital ColorDoppler Ultrasound System isintended for use in environmentswhere healthcare is provided byappropriately trained and qualifiedhealthcare professionals.	abdominal, pediatric, smallorgan(breast, thyroid, testes),neonatal and adult cephalic,trans-rectal, trans-vaginal,musculo-skeletal(conventional,superficial), adult and pediatriccardiac, peripheral vessel andurology exams.	Musculo-skeletal (Conventional);Musculo-skeletal (Superficial);Peripheral Vascular (PV); andUrology (including prostate).	modes. It is indicated fordiagnostic ultrasound imaging andfluid flow analysis in thefollowing applications: Pediatrics,Small Organ, Musculoskeletal,Peripheral Vessel, Carotid.The Digital Color Doppler PalmUltrasound System is intended foruse in environments wherehealthcare is provided byhealthcare professionals.
Type of use	Prescription Use	Prescription Use	Prescription Use	Prescription Use	Same
Operation Mode	B (2D) modeColor Doppler modePulsed Wave mode	B-Mode, M-Mode, PW-Mode,CW-Mode, Color-Mode,Power/Dirpower Mode, THI or thecombined mode (B/M-Mode,B/PW-mode, B/PW/Color)	B modeM modePWD modeColor DopplerPower DopplerTissue Harmonic ImagingCombined (B/Color Doppler,B/PWD, B/Color Doppler/PWD)	B (2D) modeB/M modeColor Doppler modeCombined (B+Color)modePulsed Wave modeFusion Harmonic Imaging modes	Similar
Application area	AbdominalSmall OrganMusculoskeletalPeripheral VesselCarotid	Fetal, abdominal, pediatric, smallorgan, neonatal and adult cephalic,trans-rectal, trans-vaginal,musculo-skeletal (conventional,superficial), adult and pediatric	FetalAbdominalPediatricSmall OrganMusculo-skeletal	PediatricsSmall OrganMusculoskeletalPeripheral VesselCarotid	Similar
	Urology	cardiac, peripheral vessel andurology	Peripheral Vascular (PV)Urology
Transducer Types	Linear arrayConvex Array	Linear arrayConvex Array	Linear arrayConvex Array	Linear array	Same
Intended user	Healthcare professionals	Healthcare professionals	Healthcare professionals	Healthcare professionals	Same
Appliedenvironment	Environments where healthcare isprovided by healthcareprofessionals	Environments where healthcare isprovided by healthcareprofessionals	Environments where healthcare isprovided by healthcareprofessionals	Environments where healthcare isprovided by healthcareprofessionals	Same
Acoustic OutputTrack	Track 3	Track 3	Track 3	Track 3	Same
Measurements	B (2D) mode: Distance, Trace,Depth, Angle, Circumference,AreaDoppler mode: Velocity	2D mode: Distance, Area, Angle,Volume, Trace Area,Circumference, Heart Rate,VolumeDoppler mode: Velocity, Time	2D mode: Distance, Ellipse,Trace, %Stenosis, VolumeM mode: Distance,Time, %StenosisDoppler mode: Velocity, Time	2D mode: Depth, Distance, Area,VolumeDoppler mode: D Velocity, TimeB/M mode: Distance, Time, HR	Similar
Design	Handheld	Floor Standing	Handheld	Handheld	Similar
Power supply	DC 5V	100-127V ~ or 220-240 V ~50/60Hz	DC 5V	DC 5V	Similar
Operatingenvironment	Ambient temperature: 5°C ~ 40°CRelative humidity: 30% ~ 85%(No condensation)Atmospheric pressure: 80kPa ~106kPa	Temperature: 0°C~40°CRelative humidity: 30%~~85% (nocondensation)Atmospheric pressure:700hPa~~1060hPa	Temperature: 10-35°C;Relative humidity: 30-75%;Barometric pressure: 700 to 1060hPa	Temperature: 10-38°C;Relative humidity: 30-75%;Barometric pressure: 700 to 1060hPa	Similar
Transportation &	Ambient temperature: -20°C ~	Temperature: -20°C~55°C	Temperature: -25-60°C;	Temperature: -10-50°C;
Storageenvironment		Relative humidity: 20%~~95% (nocondensation)Atmospheric pressure:700hPa~~1060hPa	Relative humidity: 20-90%Barometric pressure: 700 to 1060hPa	Relative humidity: ≤80%,non-condensing;Barometric pressure: 700 to 1060hPa
	55°CRelative humidity: 15% ~ 95%(No condensation)Atmospheric pressure: 80kPa ~106kPa
Weight	SCN201D: 500gSCN201L: 450g	<85kg	minisono L3-12: 175gminisono C1-6: 180g	200g
Dimensions	SCN201D:182mm×97mm×177mmSCN201L:167mm×71mm×176mm	855±5mm(Length)×510±5mm(Width) × 1190±5mm (Height)	minisono L3-12:150mm×62.5mm×25.5mmminisono C1-6:157mm×62.5mm×25.5mm	64mm×170mm×24mm	Similar
Materials	ABS, Silicone	Unpublished	Unpublished	Unpublished	Similar
Compliantstandards	ANSI AAMI ES60601-1IEC 60601-1-2IEC /TR 60601-4-2IEC 60601-1-6IEC 62366-1IEC 60601-2-37IEC 62359NEMA UD 3	ANSI AAMI ES60601-1IEC 60601-1-2IEC 62366IEC 60601-2-37NEMA UD 2	IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-2-37ISO 10993-1AIUM/NEMA UD 2	ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-2-37ISO 10993-1	Similar
Positioningsystem	Optical positioning system	Magnetic navigator positioningsystem	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:

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)]:
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;
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;
IEC 60601-1-6 Editor 3.2 2020-07 CONSOLDATED VERSION. Medical electrical coursent - Part 1-6: Galety and esserial performance-Collateral standard: Usability;
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices;
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;
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;
NEMA UD 3-2004 (R2009), Standard for Real-Time Display of Thermal and Mechanical Acoustic Ultrasound Fourprent;
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.

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.