SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6

K253949 · CHISON Medical Technologies Co., Ltd. · IYN · May 22, 2026 · Radiology

Device Facts

• Record ID: K253949
• Device Name: SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
• Applicant: CHISON Medical Technologies Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: May 22, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Sonoport Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD) +D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

Device Story

Mobile, software-controlled digital color Doppler ultrasound system; acquires ultrasound echo data via linear, convex, phased array, volume, pencil, and TEE probes; processes signals using autocorrelation (color) and FFT (Doppler); displays images in various modes (B, M, CFM, PW/CW Doppler, TDI, Fusion Harmonic, 3D/4D). Used in hospitals/clinics by qualified healthcare professionals. Output includes real-time diagnostic images, measurements, and clinical annotations. Assists clinicians in evaluating anatomy and pathology; supports clinical decision-making through visualization and quantitative analysis (e.g., IMT, volume flow, strain).

Clinical Evidence

No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, biocompatibility (ISO 10993), and acoustic output measurements.

Technological Characteristics

Mobile console with color LCD, keyboard, and multiple probe types (linear, convex, phased, volume, pencil, TEE). Connectivity includes DICOM. Safety standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatibility per ISO 10993. Software-controlled signal processing (autocorrelation, FFT).

Indications for Use

Indicated for diagnostic ultrasound imaging of fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, cardiac (adult/pediatric), musculoskeletal (conventional/superficial), peripheral vascular, trans-esophageal, trans-rectal, trans-vaginal, OB/GYN, and urology applications in hospital or clinic settings by trained professionals.

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

• SonoMax 22 Digital Color Doppler Ultrasound System (K233697)

Reference Devices

• SonoAir 90 Digital Color Doppler Ultrasound System (K223570)
• Consona N6 Diagnostic Ultrasound System (K221496)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 22, 2026

CHISON Medical Technologies Co., Ltd.
Qifei Liu
Regulatory Affairs Manager
#3 Changjiang S. Rd., Xinwu District
Wuxi, Jiangsu 214028
China

Re: K253949

Trade/Device Name: SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 Pro, SonoPort 6 Elite, SonoPort 6 Plus, SonoPort 7, SonoPort 7 Exp, SonoPort 7 Pro, SonoPort 7 Elite, SonoPort 7 Plus, SonoPort 8, SonoPort 8 Exp, SonoPort 8 Pro, SonoPort 8 Elite, SonoPort 8 Plus, SonoPort 9, SonoPort 9 Exp, SonoPort 9 Pro, SonoPort 9 Elite, SonoPort 9 Plus)

Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 23, 2026
Received: April 24, 2026

Dear Qifei Liu:

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253949 - Qifei Liu
Page 2

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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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K253949 - Qifei Liu
Page 3

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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,


Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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SonoPort Series Digital Color Doppler Ultrasound System
Page 8 of 76

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253949 | ? |
| Please provide the device trade name(s). | | ? |
| SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 Pro, SonoPort 6 Elite, SonoPort 6 Plus, SonoPort 7, SonoPort 7 Exp, SonoPort 7 Pro, SonoPort 7 Elite, SonoPort 7 Plus, SonoPort 8, SonoPort 8 Exp, SonoPort 8 Pro, SonoPort 8 Elite, SonoPort 8 Plus, SonoPort 9, SonoPort 9 Exp, SonoPort 9 Pro, SonoPort 9 Elite, SonoPort 9 Plus) | | |
| Please provide your Indications for Use below. | | ? |
| The Sonoport Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD) +D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic. | | |
| Please select the types of uses (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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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

# 510(k) Summary K253949

In accordance with 21 CFR 807.92 the following summary of information is provided:

## 1. Submitter:

Submitter: CHISON Medical Technologies Co., Ltd.
Address: No.3 Changjiang South Road, Xinwu District, Wuxi, 214028 Jiangsu, P.R. China
Contact: Mr. Liu Qifei
Tel: [phone]
Fax: [phone]
Date Prepared: November 15th, 2025

## 2. Device :

Trade Name: SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 Pro, SonoPort 6 Elite, SonoPort 6 Plus, SonoPort 7, SonoPort 7 Exp, SonoPort 7 Pro, SonoPort 7 Elite, SonoPort 7 Plus, SonoPort 8, SonoPort 8 Exp, SonoPort 8 Pro, SonoPort 8 Elite, SonoPort 8 Plus, SonoPort 9, SonoPort 9 Exp, SonoPort 9 Pro, SonoPort 9 Elite, SonoPort 9 Plus)

Common Name: Diagnostic Ultrasound System with Transducers

Classification: Regulatory Class: II
Review Category: Tier II

| Classification Name | 21 CFR Section | Product Code |
| --- | --- | --- |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

## 3. Predicate Device(s):

| Device | Model | Product Code | 510(k) Number |
| --- | --- | --- | --- |
| Main predicate device | SonoMax 22 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K233697 |
| Reference device | SonoAir 90 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K223570 |
| Reference device | Consona N6 Diagnostic Ultrasound System | IYN, IYO, ITX | K221496 |

Attachment 24
510(k) Summary

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

## 4. Device Description:

The SonoPort Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI, Fusion Harmonic Imaging modes or a combination of these mode.

## 5. Indications for Use:

The SonoPort Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM, B+CPA(PD), B+DPD, B+PW, B+CW, B+CFM+D(PW)/CW, B+CPA(PD)+D(PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by appropriately-trained qualified healthcare professionals for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular, Trans-esophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology, which is intended to be used in a hospital or medical clinic.

## 6. Summary of Non-Clinical Tests:

The SonoPort Series Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.

ANSI AAMI ES60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

Output Indices on Diagnostic Ultrasound Equipment

ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process

The following quality assurance measures are applied to the development of the system:

Risk Management

Attachment 24
510(k) Summary

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Requirement review and Design reviews
Testing on unit level (Module verification)
Integration testing (system verification)
Performance testing (Verification)
Safety testing (Verification)

The biocompatibility was evaluated and meets the ISO10993 series standard and FDA guidance.

7. Clinical Test:
No clinical testing was required.
Software Documentation for a Basic Documentation Level, per the FDA guidance document, "Guidance for Content of Premarket Submissions for Device Software Functions Document issued on June 14, 2023", is also included as part of this submission.

8. Determination of Substantially Equivalent:

Attachment 24
510(k) Summary

{7}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| Indications for Use | Fetal Abdominal Pediatric Small Organ (breast, thyroid, testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-esophageal Musculo-skeletal(Conventional, Superficial) Cardiac(adult, pediatric) Peripheral Vascular OB/GYN Urology | Fetal Abdominal Pediatric Small Organ (breast, thyroid, testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-esophageal Musculo-skeletal(Conventional, Superficial) Cardiac(adult, pediatric) Peripheral Vascular OB/GYN Urology | Fetal Abdominal Pediatric Small Organ (breast, thyroid, testes) Adult Cephalic Cardiac Adult Musculo-skeletal (Conventional, Superficial) Peripheral Vascular Trans-vaginal Urology | Fetal Abdominal Intra-operative Pediatric Small organ(breast, thyroid, testes) Neonatal cephalic Adult cephalic Trans-rectal Trans-vaginal Trans-esoph Musculo-skeletal(conventional), musculo- skeletal(superficial), Thoracic/Pleural Cardiac(adult, pediatric) Peripheral vessel Urology exams. | Same |
| Design | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve and Phase array probes. Cine play back capability Image file archive | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve , Phase array and Volume probes . Cine play back capability Image file archive | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve , Phase array and Volume probes . Cine play back capability Image file archive | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve , Phase array and Volume probes . Cine play back capability Image file archive | Same |
| Safety Compliance | ANSI AAMI ES60601-1 IEC 60601-1-2 | ANSI AAMI ES60601-1 IEC 60601-1-2 | ANSI AAMI ES60601-1 IEC 60601-1-2 | ANSI AAMI ES60601-1 IEC 60601-1-2 | Same |

Attachment 24
510(k) Summary
Page 4 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| Item | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | |
| Operation Mode | B Mode | B Mode | B Mode | B Mode | Same |
| | FHI | FHI | FHI | / | Same |
| | B/M Mode | B/M Mode | B/M Mode | B/M Mode | Same |
| | M Mode | M Mode | M Mode | M Mode | Same |
| | Dual mode | Dual mode | B/B mode | / | Same |
| | Quad mode | Quad mode | 4B mode | / | Same |
| | CFM mode | CFM mode | CFM mode | Color Doppler | Same |
| | CPA mode | CPA mode | CPA mode | Amplitude Doppler | Same |
| | DPD mode | DPD mode | DPD mode | / | Same |
| | PW mode | PW mode | PW mode | PWD | Same |
| | CW mode | CW mode | / | CWD | Same |
| | B/BC mode | B/BC mode | / | / | Same |
| | 2D Steer | 2D Steer | 2D Steer | / | Same |
| | Triplex | Triplex | Triplex | / | Same |
| | Quadplex | Quadplex | Quadplex | / | Same |
| | Curved Panoramic | Curved Panoramic | Curved Panoramic | iScape View | Same |
| | Auto TGC | Auto TGC | TGC | / | Same |
| | Biopsy | Biopsy | Biopsy | iNeedle | Same |
| | Free Steer M | Free Steer M | Free Steer M | Free Xros M | Same |
| | HPRF Mode | HPRF Mode | HPRF Mode | / | Same |
| | TDI | TDI | / | Tissue Doppler Imaging | Same |
| | Color M | Color M | Color M | Color M | Same |
| | TSS | TSS | / | / | Same |
| Sono Contrast | Sono Contrast | Sono Contrast | Contrast imaging | Same | |
| SoundFlow | SoundFlow | / | / | Same | |

Attachment 24
510(k) Summary
Page 5 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| Item | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| | SonoVector | SonoVector | / | / | Same |
| | LGC | LGC | LGC | / | Same |
| | HD 3D | HD 3D | HD 3D | Smart 3D | Same |
| | Stress Echo | Stress Echo | Stress Echo | Stress Echo | Same |
| | Strain and Strain Rate | Strain and Strain Rate | Strain and Strain Rate | / | Same |
| | Zoom | Zoom | Zoom | / | Same |
| | DICOM | DICOM | DICOM | DICOM Basic | Same |
| | Trapezoidal Imaging | Trapezoidal Imaging | Trapezoidal | / | Same |
| | Compound | Compound | Compound | / | Same |
| | SRA | SRA | SRA | / | Same |
| | ECG | ECG | ECG | ECG | Same |
| | Human Bodymark | Human Bodymark | Human Bodymark | / | Same |
| | Auto IMT | Auto IMT | Auto IMT | IMT | Same |
| | Free NT | Free NT | / | Smart NT | Same |
| | Super Needle | Super Needle | Super Needle | / | Same |
| | general measurement package | general measurement package | general measurement package | Abdomen/General Package | Same |
| | OB measurement package | OB measurement package | OB measurement package | Obstetrics Package | Same |
| | GYN measurement package | GYN measurement package | GYN measurement package | Gynecology Package | Same |
| | URO measurement package | URO measurement package | URO measurement package | Urology Package | Same |
| | cardiac measurement package | cardiac measurement package | cardiac measurement package | Cardiology Package | Same |
| | vascular measurement package | vascular measurement package | vascular measurement package | Vascular Package | Same |
| | small parts measurement package | small parts measurement package | small parts measurement package | Small Parts Package | Same |
| | Pediatric measurement | Pediatric measurement | Pediatric measurement | Pediatrics Package | Same |

Attachment 24
510(k) Summary
Page 6 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| Item | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| | package | package | package | | |
| Display Annotations | TCD measurement package | TCD measurement package | TCD measurement package | / | Same |
| | 4D software package | 4D software package | / | 4D | Same |
| | Virtual HD | Virtual HD | / | / | Same |
| | SonoOB | / | SonoOB | Smart OB | Same |
| | SonoFusion | SonoFusion | / | / | Same |
| | Q-image | Q-image | Q-image | / | Same |
| | Q-flow | Q-flow | / | / | Same |
| | Q-beam | Q-beam | Q-beam | / | Same |
| | SonoColor | SonoColor | SonoColor | / | Same |
| | SonoNeedle | / | SonoNeedle | / | Same |
| | Extended Imaging | / | Convex Array Extended | / | SE Analysis 1 |
| | Intelligent doppler | / | Intelligent doppler | / | Same |
| | Volume Flow | Volume Flow | Volume Flow | Glazing Flow | Same |
| | Elastography | Elastography | Elastography | Strain Elastography | Same |
| | SonoBeam | SonoBeam | / | / | Same |
| | AIO | AIO | AIO | / | Same |
| | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal index;Probe model; TGC Curve;Focus position;Imaging parameters;TTouch pad; System status;Gray/Color bar | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal index;Probe model;ECG ico;TGC Curve;Focus position;Imaging parameters;Dynamic Trackball indices; System status;Gray/Color bar | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal index;Probe model; TGC Curve;Focus position;Imaging parameters;Dynamic Trackball indices; System status;Gray/Color bar | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal index;Probe model; ECG ico; TGC Curve;Focus position;Imaging parameters Dynamic Trackball indices; System status;Gray/Color bar | Logo, Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal index;Probe model; ECG ico; TGC Curve;Focus position;Imaging parameters Dynamic Trackball indices; System status;Gray/Color bar |

Attachment 24
510(k) Summary
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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| Measurements | **2D mode:** Depth,Distance, Area:Ellipse, Trace, Spline, Trace, Length ,Volume :Distance, Ellipse, Ellipse + Distance, Distance Ratio, Area Ratio , IMT, Volume Flow,Color Velocity; **M mode:** Distance,Time, Slope,Heart Rate,Velocity; **Doppler mode:** D Velocity ,Time, Heart Rate, Acceleration,D Trace, ED/PS, Volume Flow; | **2D mode:** Depth,Distance, Area:Ellipse, Trace, Spline, Trace, Length ,Volume :Distance, Ellipse, Ellipse + Distance, Distance Ratio, Area Ratio , IMT, Volume Flow,Color Velocity; **M mode:** Distance,Time, Slope,Heart Rate,Velocity; **Doppler mode:** D Velocity ,Time, Heart Rate, Acceleration,D Trace, ED/PS, Volume Flow; | **2D mode:** Depth , Distance , Area: Ellipse, Trace, Spline, Cross, Trace Length ,Double Distance, Parallel, Volume: Distance, Ellipse, Ellipse + Distance, Length Ratio, Area Ratio, IMT, B Histogram, B Profile, Volume Flow, Color Velocity; **M mode:** Distance, Time, Slope, Heart Rate, Velocity; **Doppler mode:** D Velocity, Time, Heart Rate, Acceleration, D Trace, PS/ED, Volume Flow; | / | Same |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array,Volume probe 5ports | Convex Array, Phased Array, Linear Array,Volume probe 5ports | Convex Array, Phased Array, Linear Array, 4ports | Convex Array, Phased Array, Linear Array,Volume probe 4ports | Same |
| Users / Sites | Hospitals, clinics usage | Hospitals, clinics usage | Hospitals, clinics usage | Hospitals, clinics usage | Same |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum,TIS/TIB/TIC:0.1- 4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max | Ispta.3 (mW/cm2) ≤ 720, Isppa.3 (W/cm2) ≤ 190 or MI ≤ 1.9 | Same |

Attachment 24
510(k) Summary
Page 8 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

| Items | Submission Device | Main predicate device | Reference device | Reference device | Remark |
| --- | --- | --- | --- | --- | --- |
| Power Requirements | SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | SonoAir 90 Digital Color Doppler Ultrasound System (K223570) | Consona N6 Diagnostic Ultrasound System (K221496) | |
| | Isppa: 190 W/cm² max | | | | |
| Power requirements | AC :100V- 240V, Frequency:50-60Hz Operating temperature: 10-40°C; relative humidity 30-75%; Barometric pressure: 700 to 1060 hPa | AC :100V- 240V, Frequency:50-60Hz Operating temperature: 10-40°C; relative humidity 30-75%; Barometric pressure: 700 to 1060 hPa | AC :100V- 240V, Frequency:50-60Hz Operating temperature: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060 hPa | AC :100V- 240V, Frequency:50-60Hz Operating temperature: 0-40°C; relative humidity 20-85%; Barometric pressure: 700 to 1060 hPa | Same |

# SE Analysis 1:

Operation mode: Compared with equivalent devices, the submitting device adopts the same operation mode, only with a different name description. But both comply with the requirements of ANSI AAMI ES60601-1 and IEC60601-2-37, and meet clinical requirements. Therefore, they can be considered as essentially equivalent in terms of safety and effectiveness, without creating new risks, and therefore SE will not be affected.

Attachment 24
510(k) Summary
Page 9 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

# Probes Comparison:

Subject device SonoPort Series has the same/similar probes as the predicate device SonoMax Series (K233697).

| Submission Device | Main predicate device | Remark |
| --- | --- | --- |
| SonoPort Series Digital Color Doppler Ultrasound System | SonoMax 22 Digital Color Doppler Ultrasound System (K233697) | |
| L4-10 Linear probe,L3-10 Linear probe,L6-18 Linear probe,L4-15B Linear probe,L6-15i Linear probe,L4-10R Linear probe,L3-8 Linear probe,L5-14 Linear probe,L11-20 Linear probe,ML4-6 Linear probe,LA1-15 Linear probe | L4-10 Linear probe,L3-10 Linear probe,L6-18 Linear probe,L4-15B Linear probe,L6-15i Linear probe,L4-10R Linear probe,L3-8 Linear probe,L5-14 Linear probe,L11-20 Linear probe,ML4-6 Linear probe,LA1-15 Linear probe | Same |
| E4-10 Micro convex probe,C1-5 Convex probe,MC1-5 Convex probe,C1-7 Convex probe,C1-7P Convex probe,C1-6 Convex probe,C2-6 Convex probe,C4-11 Micro convex probe,E4-13 Micro convex probe,BL3-12 Bi-plane probe | E4-10 Micro convex probe,C1-5 Convex probe,MC1-5 Convex probe,C1-7 Convex probe,C1-7P Convex probe,C1-6 Convex probe,C2-6 Micro Convex probe,C4-11 Micro convex probe,E4-13 Micro convex probe,BL3-12 Micro convex probe | Same |
| S1-5P Phased array probe,S1-5 Phased array probe,S2-8 Phased array probe,S4-12 Phased array probe,MS1-5 Phased array probe | S1-5P Phased array probe,S1-5 Phased array probe,S2-8 Phased array probe,S4-12 Phased array probe,MS1-5 Phased array probe | Same |
| V2-6 Volume probe,VE4-10 Volume probe | V2-6 Volume probe,VE4-10 Volume probe | Same |
| CW2 Pencil probe | CW2 Pencil probe | Same |
| T4-6 Tee probe,MT4-6 Tee probe | T4-6 Tee probe,MT4-6 Tee probe | Same |

The 31 transducers(probes) are same, and have been cleared in the SonoMax Series Digital Color Doppler Ultrasound System (K233697), manufactured by CHISON Medical Technologies Co., Ltd. Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised.

Compared with the predicate device, there are 8 new transducers(probes) as followed: P2WS,P2,C3-12, 3C,P5,C2-9,S3-7,S4-10 which is similar with the probes cleared with predicate device SonoMax Series(K233697) and SonoAir Series(K223570). The engineering drawings of the new function transducers(probes) (P2WS,P2,C3-12, 3C,P5,C2-9,S3-7,S4-10), and the further comparison are provided as followed.

Attachment 24
510(k) Summary

{14}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 1) Further Comparison for P2WS Probe

| Comparison Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | P2WS | L5-10W | / |
| Photo | | | / |
| Probe Type | Linear probe | Linear probe | Same |
| Frequency | 4.5-10.0MHz | 4.0-10.0MHz | SE Analysis 2 |
| Indication for use | Pediatric,Small Organ (breast,thyroid,testes),Musculo-skeletal (Conventional, Superficial), Peripheral Vascular | Pediatric,Small Organ (breast,thyroid,testes), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | B/BC mode | |
| | 2D Steer | 2D Steer | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Zoom | Zoom | |
| | Trapezoidal Imaging | Trapezoidal Imaging | |
| | Elastography | Elastography | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm² maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm² maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary
Page 11 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 2) Further Comparison for P2 Probe

| Comparis on Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | P2 | L5-10W | / |
| Photo | | | / |
| Probe Type | Linear probe | Linear probe | Same |
| Frequency | 4.5-10.0MHz | 4.0-10.0MHz | SE Analysis 2 |
| Indication for use | Pediatric,Small Organ (breast,thyroid,testes),Musculo-skeletal (Conventional, Superficial), Peripheral Vascular | Pediatric,Small Organ (breast,thyroid,testes), Musculo-skeletal (Conventional, Superficial), Peripheral Vascular | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | B/BC mode | |
| | 2D Steer | 2D Steer | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Trapezoidal Imaging | Trapezoidal Imaging | |
| Elastography | Elastography | | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary

{16}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 3) Further Comparison for C3-12 Probe

| Comparison Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | C3-12 | C2-6 | / |
| Photo | | | / |
| Probe Type | Convex probe | Convex probe | Same |
| Frequency | 2.0-8.0MHz | 2.0-5.3MHz | SE Analysis 2 |
| Indication for use | Fetal, Abdominal, OB/GYN, Urology | Fetal, Abdominal, OB/GYN, Urology | Same |
| Operation Mode | B Mode | B Mode | SE Analysis 3 |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | B/BC mode | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Extended Imaging | / | |
| Elastography | Elastography | | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary
Page 13 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 4) Further Comparison for 3C Probe

| Comparis on Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoAir Series (K223570) | Remark |
| --- | --- | --- | --- |
| Probe1 | 3C | 3C | / |
| Photo | | | / |
| Probe Type | Convex probe | Convex probe | Same |
| Frequency | 1.8-4.0MHz | 1.8-4.0MHz | Same |
| Indication for use | Fetal, Abdominal, OB/GYN, Urology | Fetal, Abdominal, OB/GYN, Urology | Same |
| Operation Mode | B Mode | B Mode | SE Analysis 3 |
| | FHI | FHI | |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | B/B mode | |
| | Quad mode | 4B mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | / | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Extended Imaging | Convex Array Extended | |
| Elastography | Elastography | | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary

{18}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 5) Further Comparison for P5 Probe

| Comparison Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | P5 | C2-6 | / |
| Photo | | | / |
| Probe Type | Convex probe | Convex probe | Same |
| Frequency | 2.0-4.0MHz | 2.0-5.3MHz | SE Analysis 2 |
| Indication for use | Fetal, Abdominal, OB/GYN, Urology | Fetal, Abdominal, OB/GYN, Urology | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | B/BC mode | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Extended Imaging | Extended Imaging | |
| Elastography | Elastography | | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary
Page 15 of 19

{19}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 6) Further Comparison for C2-9 Probe

| Comparis on Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | C2-9 | C2-6 | / |
| Photo | | | / |
| Probe Type | Convex probe | Convex probe | Same |
| Frequency | 2.0-9.0MHz | 2.0-5.3MHz | SE Analysis 2 |
| Indication for use | Fetal, Abdominal, OB/GYN, Urology | Fetal, Abdominal, OB/GYN, Urology | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | B/BC mode | B/BC mode | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | HPRF Mode | HPRF Mode | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | Elastography | Elastography | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm2 max | Same |

Attachment 24
510(k) Summary

{20}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 7) Further Comparison for S3-7 Probe

| Comparison Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | S3-7 | S2-8 | / |
| Photo | | | / |
| Probe Type | Phased array probe | Phased array probe | Same |
| Frequency | 3.0-7.0MHz | 3.0-8.0MHz | SE Analysis 2 |
| Indication for use | Cardiac (adult, pediatric) | Cardiac (adult, pediatric) | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | CW mode | CW mode | |
| | B/BC mode | B/BC mode | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | Free Steer M | Free Steer M | |
| | HPRF Mode | HPRF Mode | |
| | TDI | TDI | |
| | Color M | Color M | |
| | Sono Contrast | Sono Contrast | |
| | HD 3D | HD 3D | |
| | ECG | ECG | |
| | Elastography | Elastography | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary
Page 17 of 19

{21}

CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

Table 8) Further Comparison for S4-10 Probe

| Comparison Items | Subject Device SonoPort Series (K253949) | Reference Device Legally marketed SonoMax Series (K233697) | Remark |
| --- | --- | --- | --- |
| Probe1 | S4-10 | S4-12 | / |
| Photo | | | / |
| Probe Type | Phased array probe | Phased array probe | Same |
| Frequency | 4.0-10.0MHz | 4.0-10.0MHz | Same |
| Indication for use | Cardiac (adult, pediatric) | Cardiac (adult, pediatric) | Same |
| Operation Mode | B Mode | B Mode | Same |
| | B/M Mode | B/M Mode | |
| | M Mode | M Mode | |
| | Dual mode | Dual mode | |
| | Quad mode | Quad mode | |
| | CFM mode | CFM mode | |
| | CPA mode | CPA mode | |
| | DPD mode | DPD mode | |
| | PW mode | PW mode | |
| | CW mode | CW mode | |
| | B/BC mode | B/BC mode | |
| | Triplex | Triplex | |
| | Quadplex | Quadplex | |
| | Curved Panoramic | Curved Panoramic | |
| | Free Steer M | Free Steer M | |
| | HPRF Mode | HPRF Mode | |
| | TDI | TDI | |
| | Color M | Color M | |
| | Sono Contrast | Sono Contrast | |
| | ECG | ECG | |
| | Elastography | Elastography | |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same |

Attachment 24
510(k) Summary
Page 18 of 19

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CHISON Medical Technologies Co., Ltd.
SonoPort Series Digital Color Doppler Ultrasound System

## SE Analysis 2

Although the frequency is different, all of them comply with the requirements of IEC 60601-1 & IEC 60601-1-2 & IEC 60601-2-37 and meet clinical requirements, and no new risk is raised.

## SE Analysis 3

Although the operation mode is different, the new operation modes are both comply with the requirements of ANSI AAMI ES60601-1 and IEC60601-2-37, and meet clinical requirements.

Moreover, compared with predicate device, the subject device (SonoPort Series) complies with the same regulation and safety standards and has the consistent acoustic output levels.

The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use. Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

## 9. Conclusion

In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Technologies Co., Ltd. concludes that the SonoPort Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.

Attachment 24
510(k) Summary