Who is the manufacturer of SonoAir Series Digital Color Doppler Ultrasound System?

CHISON Medical Technologies Co., Ltd. filed the 510(k) submission for SonoAir Series Digital Color Doppler Ultrasound System (K223570).

What is the FDA product code for SonoAir Series Digital Color Doppler Ultrasound System?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SonoAir Series Digital Color Doppler Ultrasound System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SonoAir Series Digital Color Doppler Ultrasound System?

EBit 90 Digital Color Doppler Ultrasound System (K162172).

Who can help prepare an FDA 510(k) submission like SonoAir Series Digital Color Doppler Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SonoAir Series Digital Color Doppler Ultrasound System

K223570 · CHISON Medical Technologies Co., Ltd. · IYN · Mar 31, 2023 · Radiology

Device Facts

Record ID	K223570
Device Name	SonoAir Series Digital Color Doppler Ultrasound System
Applicant	CHISON Medical Technologies Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Mar 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.

Device Story

Mobile, software-controlled, general-purpose diagnostic ultrasound system; acquires ultrasound echo data via linear, convex, or phased array probes. Transforms inputs into B-mode, M-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler images. Used in hospitals/clinics by trained clinicians. Output displayed on integrated color LCD monitor; used for clinical diagnostic imaging and measurements (e.g., distance, area, volume, flow). Assists clinicians in evaluating anatomical structures and physiological conditions; supports clinical decision-making through real-time visualization and quantitative analysis.

Clinical Evidence

No clinical testing was required. Device safety and effectiveness were established through bench testing, including electrical, mechanical, thermal, and electromagnetic compatibility (EMC) testing, as well as biocompatibility evaluation per ISO 10993 standards.

Technological Characteristics

Mobile console with keyboard, power module, and color LCD. Supports linear, convex, and phased array probes. Imaging modes: B, M, CFM, CPA, DPD, PW, Fusion Harmonic Imaging. Safety standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatibility: ISO 10993 series. Software-controlled; moderate level of concern.

Indications for Use

Indicated for diagnostic ultrasound imaging of fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, adult cardiac, musculoskeletal (conventional, superficial), peripheral vascular, trans-vaginal, and urological structures. Intended for use by trained clinicians in hospitals or clinics.

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

EBit 90 Digital Color Doppler Ultrasound System (K162172)

Reference Devices

XBit 90 Digital Color Doppler Ultrasound System (K200780)

Related Devices

K210743 — ACUSON Redwood Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Apr 1, 2021
K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 17, 2022
K210959 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 24, 2021
K162845 — DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 15, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ March 31, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it, representing the Department of Health & Human Services-USA. To the right, there is a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG' in blue and 'ADMINISTRATION' in a smaller font size below. CHISON Medical Technologies Co., Ltd. % Yingying Chen RA Specialist No.3 Changjiang South Road, Xinwu District Wuxi, Jiangsu 214028 CHINA #### Re: K223570 Trade/Device Name: SonoAir Series Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 24, 2023 Received: February 27, 2023 #### Dear Yingying 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 (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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223570 #### Device Name SonoAir Series Digital Color Doppler Ultrasound System Indications for Use (Describe) The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary K223570 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 : | Mrs. Chen Yingying | | Tel: | +86-510-8531-0019 | | Fax: | +86-510-8531-0021 | | Date Prepared: | October 14th, 2022 | #### 2. Device : Trade Name: SonoAir Series Digital Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System with Transducers Classfication: Regulatory Class: II Review Category: Tier II | Classfication 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 | EBit 90 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K162172 | | Reference device | XBit 90 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K200780 | #### 4. Device Description: The SonoAir 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 B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed 510(k) Summary {4}------------------------------------------------ CHISON Medical Technologies Co., Ltd. Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode. #### 5. Indications for Use: The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD), B+DPD,B+PW, B+ CFM + D (PW), B+ CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by an appropriately-trained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ),Adult Cephalic,Cardiac Adult, Musculoskeletal(Conventional, Superficial),Peripheral Vascular, Trans-vaginal and Urology, which is intended to be used in a hospital or medical clinic. ### 6. Summary of Non-Clinical Tests: The SonoAir 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 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. {5}------------------------------------------------ #### CHISON Medical Technologies Co., Ltd. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission. #### 8. Determination of Substantially Equivalent: | Items | Main Predicate Device | Reference Device | Submission Device | Remark | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Items | EBit 90 Digital Color Doppler Ultrasound System (K162172) | XBit 90 Digital Color Doppler Ultrasound System (K200780) | SonoAir Series Digital Color Doppler Ultrasound System | | | Indicatio ns for Use | Fetal Abdominal Pediatric Small Organ (breast, thyroid ,testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo- skeletal( Conventiona I, Superficial) Cardiac(adult ,pediatr ic) Peripheral Vascular Urology Trans-esophageal | Fetal Abdominal Pediatric Small Organ (breast, thyroid ,testes) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo- skeletal( Conventiona I, Superficial) Cardiac(adult ,pediatr ic) Peripheral Vascular OB/GYN,Urology Trans-esophageal | Fetal Abdominal Pediatric Small Organ (breast, thyroid ,testes) Adult Cephalic Trans-vaginal Musculo- skeletal( Conventiona I, Superficial) Cardiac Adult Peripheral Vascular Urology | SE Analysis 1 | | Design | 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 and Phase array probes. Cine play back capability Image file archive | Same | | Operati | TGC 8 slider | TGC 8 slider | TGC 8 slider | Same | | | Depth Range:0-30.8 cm | Depth Range: 0-45 cm | Depth Range:0- 22.7 cm | SE Analysis 2 | | ng Controls | 256 shades of gray | 256 shades of gray | 256 shades of gray | Same | | ltems | B Dynamic range control: 30-180dB | B Dynamic range control: 20-180dB | B Dynamic range control: 30-180dB | Same | | | Gain:0-255, 1/step | Gain:0-255, 1/step | Gain:0-255, 1/step | Same | | | Focal Number: adjustable | Focal Number: adjustable | Focal Number: adjustable | Same | | | Focus position: adjustable | Focus position: adjustable | Focus position: adjustable | Same | | | B steer: available on linear transducers | B steer: available on linear transducers | B steer: available on linear transducers | Same | | | B Persistence: 7 steps | B Persistence: 7 steps | B Persistence: 7 steps | Same | | | ROI size/position: adjustable | ROI size/position: adjustable | ROI size/position: adjustable | Same | | | Color Wall Filter settings:8 steps | Color Wall Filter settings:8 steps | Color Wall Filter settings:4 steps | | | | Color Baseline:16 steps | Color Baseline:16 steps | Color Baseline: 7 steps | SE Analysis 2 | | | Color Maps: 21 maps | Color Maps: 21 maps | Color Maps: 9 maps | | | | PW sweeping speed: 6 steps | PW sweeping speed: 6 steps | PW sweeping speed: 3 steps | | | | Color Invert: on/off | Color Invert: on/off | Color Invert: on/off | Same | | | PW Wall Filter: 7 steps | PW Wall Filter: 7 steps | PW Wall Filter: 7 steps | Same | | | PW sample volume: 0.5-30mm (PW only), 13 steps | PW sample volume: 0.5-30mm (PW only) | PW sample volume: 1-8mm (PW only) | SE | | | PW angle correction:- 89~89degrees, 1/step | PW angle correction:- 89~89degrees, 1/ste | PW angle correction:- 70-70degrees, 1/step | Analysis 2 | | | Baseline: 8steps | Baseline: 8steps | Baseline: 6steps | | | | Cine control:step, play backward, play continuously | Cine control:step, play backward, play continuously | Cine control:step, play backward, play continuously | Same | | | Doppler Auto Trace | Doppler Auto Trace | Doppler Auto Trace | Same | | | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Same | | Safety Compliance | ANSI AAMI ES60601-1 IEC 60601-1-2 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | ANSI AAMI ES60601-1 IEC 60601-1-2 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | ANSI AAMI ES60601-1 IEC 60601-1-2 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-23 IEC 60601-2-37 | Same | | | | | | | | Operation | B mode | B mode | B Mode | Same | | | Dual mode | B/M Mode | B/B Mode | Same | {6}------------------------------------------------ SonoAir Series Digital Color Doppler Ultrasound System {7}------------------------------------------------ | | | CHISON Medical Technologies Co., Ltd. | | | | | |--|--|---------------------------------------|--|--|--|--| |--|--|---------------------------------------|--|--|--|--| SonoAir Series Digital Color Doppler Ultrasound System | Mode | Quad mode | M mode | 4B Mode | Same | |------|--------------------------------|--------------------------------|--------------------------------|------| | | B/M Mode | Dual mode | B/M Mode | Same | | | M mode | Quad mode | M Mode | Same | | | CFM mode | CFM mode | CFM Mode | Same | | | PW mode | CPA Mode | PW Mode | Same | | | CPA(PD) Mode | DPD Mode | CPA(PD) Mode | Same | | | DPD Mode | PW mode | DPD Mode | Same | | | 2D Steer | 2D Steer | 2D Steer | Same | | | Triplex Mode | Triplex Mode | Triplex Mode | Same | | | Quadplex Mode | Quadplex Mode | Quadplex Mode | Same | | | / | HD 3D Mode | HD 3D Mode | Same | | | Free Steer M | Free Steering M | Free Steer M | Same | | | HPRF Mode | HPRF Mode | HPRF Mode | Same | | | FHI | FHI | FHI | Same | | | Color M Mode | Color M Mode | Color M Mode | Same | | | Trapezoidal Mode | Trapezoidal Mode | Trapezoidal Mode | Same | | | Elastography Mode | Elastography Mode | Elastography Mode | Same | | | / | Sono Contrast | Sono Contrast | Same | | | Super Needle | Super Needle | Super Needle | Same | | | Biopsy | / | Biopsy | Same | | | Curved Panoramic | Curved Panoramic | Curved Panoramic | Same | | | TGC | / | TGC | Same | | | / | LGC | LGC | Same | | | Chroma | Chroma | Chroma | Same | | | / | X-contrast | X-contrast | Same | | | Q-beam | Q-beam | Q-beam | Same | | | Compound | Compound | Compound | Same | | | AIO | AIO | AIO | Same | | | SRA | SRA | SRA | Same | | | Q-image | Q-image | Q-image | Same | | | general measurement package | general measurement package | general measurement package | Same | | | OB measurement package | OB measurement package | OB measurement package | Same | | | GYN measurement package | GYN measurement package | GYN measurement package | Same | | | URO measurement package | URO measurement package | URO measurement package | Same | | | cardiac measurement package | cardiac measurement package | cardiac measurement package | Same | {8}------------------------------------------------ | CHISON Medical Technologies Co., Ltd. | | | SonoAir Series Digital Color Doppler Ultrasound System | | | | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | vascular measurement package | | | vascular measurement package | | | Same | | | small parts measurement package | | | small parts measurement package | | | Same | | | Pediatric measurement package | | | Pediatric measurement package | | | Same | | | TCD measurement package | | | TCD measurement package | | | Same | | | / | | | Free OB | | | Same | | | Bodymark | | | Bodymark | | | Same | | | Auto IMT | | | Auto IMT | | | Same | | | / | | | SonoColor | | | Same | | | Stress Echo | | | Stress Echo | | | Same | | | / | | | Strain and Strain Rate | | | Same | | | Display Annotations | Logo; Hospital Name; Exam date;Exam time; AcousticPower; Mechanical index; Tissue thermal indes; ID,Last name,First Name,Middleinitial, Gender, Age; Probe model;ECG ico;Operator; TGC Corve;Focus position;Thumbnail; Imagingparameters; Dynamic | | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal indes;Probe model;ECG ico;TGC Corve;Focus position;Imaging parameters;Dynamic Trackball indices; System status;Gray/Color bar | | | Logo; Hospital Name; Exam date;Exam time; Acoustic Power ; Mechanical index;Thermal indes;Probe model; TGC Corve;Focus position;Imaging parameters;TTouch pad; System status;Gray/Color bar | Same | {9}------------------------------------------------ SonoAir Series Digital Color Doppler Ultrasound System | Measurements | 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; | 2D mode: Depth , Distance ,Area: Ellipse, Trace, Spline, Trace Length , Double Distance Parallel ,Volume :Dist ance, 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,PS/ED Volume Flow; | 2D mode: Depth , Distance ,Area: Ellipse, Trace, Spline, Trace, Length ,Volume : Dist ance, Ellipse, Ellipse + Distance, Distance Ratio, Area Ratio , IMT, Volume Flow; M mode: Distance,Time, Slope,Heart Rate,Velocity; Doppler mode: D Velocity ,Time , Heart Rate, Acceleration ,D Trace,ED/PS, Volume Flow; | Same | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Transducer Types & Connect ors | Convex Array, Phased Array, Linear Array, Volume probe 2 ports | Convex Array, Phased Array, Linear Array,Volume probe 4ports | Convex Array, Phased Array, Linear Array, 4ports | Same | | Users / Sites | 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 Isppa: 190 W/cm² max | Track 3; MI, TIS, TIC, TIB Derated Ispta: 720mW/cm² maximum,TIS/TIB/TI C:0.1-4.0 Range, Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max | Same | | Power Requirements | Power requirements: AC :100V- 240V, Frequenzy:50-60Hz Operating temperature: 10-40° C; relative humidity 30-75%; Barometric pressure: 700 to 1060hPa | Power requirements: AC :100V- 240V, Frequenzy:50-60Hz Operating temperature: 0-40°C; relative humidity 30-75%; Barometric pressure: 700 to 1060 hPa | Power requirements: AC :100V- 240V, Frequenzy:50-60Hz Operating temperature: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060 hPa | SE Analysis 3 | ## SE Analysis 1: Compared with the predicate device, the submission device has some differences in {10}------------------------------------------------ CHISON Medical Technologies Co., Ltd. indications for use. Principles of operation transducer configuration is the same, the only difference is the number of probe. Both of the predicate and submission device comply with the requirements of ANSI AAMI ES60601-1& IEC 60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected. #### SE Analysis 2: Operation Controls, compared with the predicate device, the submission device employs the same operation controls design ,but has some differences in setting range. But both of them comply with the requirements of ANSI AAMI ES60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected. #### SE Analysis 3: Compared with the predicate device, the submission device has some differences in operating temperature. But the operating temperature of the device is contained within the scope of the predicate device. Both them comply with the requirements of ANSI AAMI ES60601-1. Therefore they can be considered Substantially Equivalent in safety, 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 SonoAir Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.