The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler(CWD), 3D/4D, Elastography, Contrast Harmonic Imaging(CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging(TDD), Tissue Harmonic Imaging(THI), Macro Fidelity Imaging(MFI), ECG, Vector Space Flow (VS Flow), DICOM.

Device Description

This system is a Track 3 device and the software used in Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Document Level for the Ultrasound Software is Basic.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Important Note: The provided document is a 510(k) summary for an ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and intended use. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence. Therefore, many of the requested items related to a clinical study (like test set sample size, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI algorithm) are not applicable to this submission.

The document discusses non-clinical testing related to compliance with various international standards for medical electrical equipment, software, biocompatibility, and risk management. This type of testing ensures the device meets safety and performance criteria, but it's not a performance study in the sense of evaluating diagnostic accuracy against a ground truth for a specific clinical application.

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria are primarily based on meeting safety standards and demonstrating comparable technical characteristics and intended use to the predicate device. There isn't a table of specific performance metrics for clinical accuracy as would be found in a study for an AI-powered diagnostic device.

Acceptance Criteria Category	Description	Reported Device Performance
Intended Use	The device's intended use and application sites should be practically identical or a logical extension (with appropriate justification) of the predicate device.	"Compared with predicate device Apogee 2300 (K173000), subject device adds description of imaging mode, and on the basis of predicate device imaging mode, adds Contrast Harmonic Imaging (CHI) and its corresponding application site: Liver. Other intended uses and application sites are practically identical." This was deemed acceptable as it's an addition of a known imaging mode and application.
Technical Characteristics	Basic and key technical features (Operation Principle, Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management, Acoustic power levels, Materials of probes, Probes) should be the same as or comparable to the predicate device, without raising new questions of safety or efficacy.	"The basic and key technical features of the subject Device are the same as the predicate device Apogee 2300 (K173000), including Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management.""The Acoustic power levels of subject devices meet the limits of FDA same as the predicate device Apogee 2300 (K173000).""The materials of probes with subject device are same as the predicate device of Apogee 2300 (K173000)."New probes were introduced but their applications were stated to be "within the indications for use of the primary predicate system Apogee 2300 (K173000)." "Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices."
Safety Standards Compliance	The device must comply with relevant international and national safety and performance standards for medical devices and ultrasound equipment.	The device "comply[s] with and/or were tested in accordance with the following FDA guidance and International Standards:"- IEC 60601-1 (Basic safety & essential performance)- IEC 60601-1-2 (EMC)- IEC 60601-2-37 (Ultrasonic diagnostic & monitoring equipment)- IEC 60601-2-25 (Electrocardiographs)- ISO 14971 (Risk management)- ISO 10993 (Biocompatibility parts 1, 5, 10, 23)- IEC 62304 (Software life cycle)- IEC 60601-1-6 (Usability)- IEC 62366-1 (Usability engineering)- ISO 15223-1 (Symbols for labels)- ISO 13485 (Quality management systems)- FDA Guidance for PMS for Software in Medical Devices- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Software Document Level	Software documentation should meet the basic document level requirements, indicating proper development and verification processes.	"The Document Level for the Ultrasound Software is Basic."

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

Not Applicable. The document explicitly states: "Clinical testing is not necessary for the Apogee C2... Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set in the traditional sense of a performance study to evaluate diagnostic accuracy. The "test set" for this submission refers to the physical device being tested against safety and performance standards, and comparison of its specifications to the predicate device.

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. As explained above, no clinical test set requiring expert-established ground truth was part of this 510(k) submission.

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

Not Applicable. No clinical test set with adjudication was part of this 510(k) submission.

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. This submission is for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

No. This submission is for an ultrasound imaging system. It states the software is "Ultrasound Software by SIUI" and is "based on the predicate device." It does not describe a standalone AI algorithm for diagnostic interpretation.

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

Not Applicable. For the non-clinical testing performed (compliance with standards), the "ground truth" is adherence to the specifications of those standards (e.g., electrical safety limits, EMC performance, software lifecycle processes) and comparison of technical parameters to the predicate device. There was no clinical ground truth established for diagnostic performance.

8. The sample size for the training set

Not Applicable. This submission does not describe an AI/machine learning model that would require a training set of patient data. The "software" referred to is the operating system and imaging processing software of the ultrasound machine, not a data-driven AI algorithm in the diagnostic sense implied by this question.

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

Not Applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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Build Correspondence

March 31, 2025

Shantou Institute of Ultrasonic Instruments Co., Ltd. Guang Chen Regulatory Affairs #77. Jinsha Road Shantou, CN 515041 CHINA

Re: K243178

Trade/Device Name: Digital Color Doppler Ultrasound Imaging System (Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 30, 2024 Received: September 30, 2024

Dear Guang Chen:

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 (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.

Image /page/0/Picture/10 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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Page

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 (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.

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 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-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 Ultrasound and Mammography Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243178

Device Name

Digital Color Doppler Ultrasound Imaging System (Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K3. Apogee K5. Apogee U1. Apogee U2. Apogee U3. Apogee U3. Apogee U5 )

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

This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is:K243178

Submitter 5.1

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)

77 Jinsha Road, Shantou, Guangdong 515041, China

Tel: 86-754-88250150

Fax: 86-754-88251499

Contact Person: Chen Guang

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: September 30, 2024

5.2 Device

Name of Device:

Apogee C1 Digital Color Doppler Ultrasound Imaging System Apogee C2 Digital Color Doppler Ultrasound Imaging System Apogee C3 Digital Color Doppler Ultrasound Imaging System Apogee C5 Digital Color Doppler Ultrasound Imaging System Apogee K1 Digital Color Doppler Ultrasound Imaging System Apogee K2 Digital Color Doppler Ultrasound Imaging System Apogee K3 Digital Color Doppler Ultrasound Imaging System Apogee K5Digital Color Doppler Ultrasound Imaging System Apogee U1 Digital Color Doppler Ultrasound Imaging System

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Apogee U2 Digital Color Doppler Ultrasound Imaging System

Apogee U3 Digital Color Doppler Ultrasound Imaging System

Apogee U5Digital Color Doppler Ultrasound Imaging System

510(k) submitter: SIUI

Classification Name:

Ultrasonic pulsed Doppler imaging system 90-IYN	(per 21 CFR 892.1550)
Ultrasonic pulsed echo imaging system	90-IYO (per 21 CFR 892.1560)
Diagnostic ultrasonic transducer	90-ITX (per 21 CFR 892.1570)
Regulatory Class: II

Product Code: IYN, IYO, ITX

Main Predicate Device 5.3

Name of Predicate Device:

Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000)

510(k) holder: SIUI

Regulatory Class: II

Product Code: IYN, IYO, ITX

Classification Name:

Ultrasonic pulsed doppler imaging system	90-IYN	(per 21 CFR 892.1550)
Ultrasonic pulsed echo imaging system	90-IYO	(per 21 CFR 892.1560)
Diagnostic ultrasonic transducer	90-ITX	(per 21 CFR 892.1570)

5.4 Device Description

5.4.1 Description

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5.4.2 Comparisons of Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U2, Apogee U2, Apogee U3, Apogee U5 devices

Readius Series used the same safe critical components, with the same circuit modules and working principles, and the same appearance(See Fig.2).

Image /page/6/Picture/4 description: The image shows two different views of a portable ultrasound machine. The machine has a laptop-like design with a screen and a keyboard area with various buttons and controls. The screen displays a graphic with the text "PORTABLE" visible. The machine also features a handle on top for easy carrying.

Fig. 2 Outside Drawing of the Main Unit

The mechanical structure is designed for the market requirements of the devices according to the requirements of international general safety standard (IEC 60601-1). The hardware design is exactly the same of Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5. Subject to market positioning, the Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1. Apogee U2. Apogee U3. Apogee U5 have different software functional configurations. See the table below.

	Functional division description
Model	TrapezoidalImaging	S-Beam	AnatomicalM-mode	ContinuousWave Doppler
Apogee U5	√	√	√	√
Apogee U3	o	√	o	o
Apogee U2	o	o	o	√
Apogee U1	o	o	√	o

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Apogee K1			O	O
Apogee K2	O		O
Apogee K3	O	O
Apogee K5		O		O
Apogee C1			C
Apogee C2	O
Apogee C3		O
Apogee C5		O	C	O

Note: "N" means "standard configuration", "o" means "option configuration".

5.5 Indications for Use

The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), 3D/4D, Elastography, Contrast Harmonic Imaging (CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging (TDI), Tissue Harmonic Imaging (THI), Macro Fidelity Imaging (MFI), ECG, Vector Space Flow (VS Flow), DICOM.

5.6 Comparison of Technological Characteristics with the Predicate Device

The Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Doppler Ultrasound Imaging Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to predicate devices.

Type	Manufacturer	Device	510 (K) Number
Primarypredicate device	SIUI	Apogee 2300 Digital ColorDoppler UltrasoundImaging System	K173000

Intended Use Comparison:

Compared with predicate device Apogee 2300 (K173000), subject device adds

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description of imaging mode, and on the basis of predicate device imaging mode, adds Contrast Harmonic Imaging (CHI) and its corresponding application site: Liver. Other intended uses and application sites are practically identical.

Technical Characteristics Comparison:

The basic and key technical features of the subject Device are the same as the predicate device Apogee 2300 (K173000), including Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management.

Acoustic power levels Comparison:

The Acoustic power levels of subject devices meet the limits of FDA same as the predicate device Apogee 2300 (K173000)

Materials of probes Comparison:

The materials of probes with subject device are same as the predicate device of Apogee 2300 (K173000).

Probes Comparison:

Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 has the following new probes: V6LF, C5LF, C6LF, ECBP, ECBP-5, L14LC, P5FC. Other probe models are basically consistent with the predicate device's probe models, except that the model suffix has been changed due to sales needs. Applications for these probes are within the indications for use of the primary predicate system Apogee 2300 (K173000).

Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.

5.7 Non-clinical Testing Summary

The Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Doppler Ultrasound Imaging System comply with and/or were tested in accordance with the following FDA guidance and International Standards:

. IEC 60601-1:2005+ AMD1:2012+AMD2:2020 Medical electrical equipment -

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Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
. IEC 60601-2-37:2007+A1:2015 Medical electrical equipment - - Part 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
. IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
. ISO 14971:2019 Medical devices - Application of risk management to medical devices
ISO 10993-1:2018 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
ISO 10993-10:2021 Biological evaluation of medical devices - Part 10:Tests for skin sensitization
. ISO 10993-23:2021 Biological evaluation of medical devices - Part 23:Tests for irritation
IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes
IEC 60601-1-6:2010+ AMD1:2013+AMD2:2020 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
IEC 62366-1: 2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
. ISO 15223-1:2021 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
. ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

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The subject device and the predicate device are comparable in terms of technical features, general functions, applications and intended uses. The test results showed compliance with the above standards. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate.

5.8 Clinical Testing

Clinical testing is not necessary for the Apogee C2, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device.

5.9 Conclusion

The subject device Apogee C1, Apogee C2, Apogee C3, Apogee C5, Apogee K1, Apogee K2, Apogee K3, Apogee K5, Apogee U1, Apogee U2, Apogee U3, Apogee U5 Digital Color Doppler Ultrasound Imaging System and the predicate device SIUI Apogee 2300 Digital Color Doppler Ultrasound Imaging System are comparable in terms of technical features, general functions, applications and indications for use.

Regulation Number and Section

N/A