CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE

K140364 · Chison Medical Imaging Co., Ltd. · IYN · Jun 2, 2014 · Radiology

Device Facts

• Record ID: K140364
• Device Name: CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
• Applicant: Chison Medical Imaging Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jun 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

Device Story

The Q Series & i7, i8, i9 are integrated, software-controlled diagnostic ultrasound systems available as portable (Q6/Q8/Q9/Q10) or roll-around (i7/i8/i9) units. Systems acquire ultrasound echo data via piezoelectric transducers to generate images in B-Mode, M-Mode, Pulsed/Continuous Wave Doppler, Color/Power/Directional Power Doppler, Tissue Doppler, and 3D/4D modes. Operated by physicians in hospitals or clinics, the device processes signals to display high-resolution images and perform measurements (e.g., Auto IMT, vascular, small parts, pediatric packages). Outputs include real-time imaging, cine playback, and archived data. Healthcare providers use these outputs for clinical diagnosis and guidance of procedures like biopsies (via 'Supper needle' feature). Benefits include non-invasive diagnostic imaging and fluid flow analysis across various clinical applications.

Clinical Evidence

Bench testing only. No clinical data was required. Verification testing confirmed the system and added transducers met design specifications and safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993).

Technological Characteristics

System uses piezoelectric transducers for ultrasound echo acquisition. Features include digital multi-beam forming, 15"-19" LCD monitors, and connectivity via USB, LAN, VGA, and S-Video. Software-controlled modes include B, M, PW/CW Doppler, Color/Power Doppler, TDI, 3D/4D, Elastography, and Curved Panoramic Imaging. Biocompatible patient-contact materials. Power supply 100V-240V, 50-60Hz. Sterilization/disinfection per standard clinical ultrasound protocols.

Indications for Use

Indicated for use by qualified physicians for diagnostic ultrasound imaging or fluid flow analysis of the human body, including Fetal/OB, Abdominal (GYN/Urology), Pediatric, Small Organs (breast, testes, thyroid), Neonatal/Adult Cephalic, Cardiac (adult/pediatric), Peripheral Vascular, Musculo-skeletal (conventional/superficial), and Transvaginal applications.

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

• GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System (K101236)
• CHISON iVis60EXPERT, Q6/Q8, i7 Diagnostic Ultrasound Systems (K120801)

Submission Summary (Full Text)

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510(K) Submis

# 510(k) Summary

This Summary of 510 (K ) Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(K) number: K140364

1. Date of submission : January 12, 2014

- 2. Submitter:
Chison Medical Imaging Co., Ltd. No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142

| Contact: | Ms. Ruoli Mo | |
|-------------|----------------------------------------|-----------------------|
| Tel: | [phone], 85310593 | Fax: [phone] |
| U.S. Agent: | Leiker Regulatory & Quality Consulting | |
| | 7263 Cronin Circle | |
| | Dublin, CA 94568 | |
| Contact: | Bob Leiker | |
| Tel: | [phone] | Fax: [phone] |

# 3. Proposed Device Identification:

Trade/Proprietary: Q Series & i7, i8, i9 Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System with Accessories

Classification: 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 ultrasonic transducer | 892.1570 | 90-ITX |

# 4. Legally Marketed Predicate Device:

K101236, GE Voluson E6/E8 /E8 Expert Diagnostic Ultrasound System K120801 CHISON iVis60EXPERT, Q6/Q8, i7 Diagnostic Ultrasound Systems

# 5. Device Description:

510(k) Summary

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The Q6/Q8/Q9/Q10/i7/i8 /i9 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The CHISON ultrasound system can be configured either as a portable model (Q6/Q8/Q9/Q10), or as a roll-around model on wheels (i7/i8/i9). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years.

This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes.3D/4D.

# 6. Indications for Use:

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

# 7. Summary of Modifications and Newly Added Features

The Q Series & i7, i8. i9 Diagnostic Ultrasound System employs the same technology as the predicate devices. This submission device is a modification to CHISON iVis60EXPERT,Q6 /Q8, i7 Diagnostic Ultrasound Systems previously cleared in K120801. The submission device also has the same intended uses and basic operating modes as the predicate devices. The following is a brief overview of the modifications and newly added features. Detailed information is found in Section 1 4 General Device Description of this submission, while Section

1 5 Predicate Device Comparison to Legally Marketed Device includes a discussion of substantial equivalence with the predicate device(s).

# Newly added transducers:

- D3C60L-B D3C60L-C D7L40L-C D12L40L D7C10L-C V6C10L D5C20L-A D3C20L D6C15L-A D2D16L
510(k) Summary

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## V4C40L-C

# Newly added software options:

2D Steer

Elastography

Curved Panoramic Imaging

Supper needle

IMT: Auto IMT measurement

vascular measurement package

small parts measurement package

Pediatric measurement package

All of the above modifications have been compared with the predicate devices. The results show that these modifications are substantially equivalent to the predicate devices.

# 8. Testing:

Laboratory testing was conducted to verify that the 530 system with added transducer met all design specification and was substantially equivalent to the Predicate Device.

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.

IEC 60601-1: 2005 Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NEMA UD 2-2004. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

## 9. Clinical Test:

No clinical testing was required.

# 10. Comparison to Predicate Device:

# Table 1 Substantial Equivalence Comparison

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510(K) Submission

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| Product Name<br>(K number) | Predicate Device | CHISON<br>iVis60EXPERT,Q6/Q8,i7<br>K120801 | Submission Device<br>Q Series & i7,i8,i9<br>TBD | Remark |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Indications<br>for Use | Voluson E8/E8Expert<br>K101236 | Fetal (Obstetrics);<br>Abdomen;<br>Small Organ (Thyroid, testes<br>and breast etc);<br>Cardiac (adult and pediatric);<br>Musculo-skeletal<br>(Conventional and Superficial);<br>Peripheral Vascular,<br>Transvaginal,<br>OB/Gyn and Urology. | Fetal (Obstetrics);<br>Abdomen;<br>Pediatric;<br>Small Organ (Thyroid, testes and<br>breast);<br>Cardiac (adult and pediatric);<br>Musculo-skeletal (Conventional and<br>Superficial);<br>Peripheral Vascular,<br>Transvaginal,<br>OB/Gyn and Urology. | Same |
| | Fetal (Obstetrics);<br>Abdominal (including GYN, pelvic<br>and infertility monitoring/follicle<br>development); Pediatric;<br>Small Organ (breast, testes, thyroid<br>etc); Neonatal and Adult Cephalic;<br>Cardiac (adult and pediatric);<br>Musculo-skeletal Conventional and<br>Superficial;<br>Peripheral Vascular;<br>Transrectal;<br>Transvaginal and Intraoperative<br>(abdominal, PV and neurological). | Autocorrelation for color<br>processing, and FFT for<br>pulse and CW Doppler<br>processing. Supporting Linear, Curve<br>linear, Phase array and<br>Pencil probes. Cine play back capability Image file archive Software upgrade with<br>USB flash drive. Digital multi-beam<br>forming | Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing. Supporting Linear, Curve<br>linear, Phase array and<br>Pencil probes. Cine play back capability Image file archive Software upgrade with USB<br>flash drive. Digital multi-beam forming | Same |
| Design | Autocorrelation for color<br>processing and FFT for<br>pulse and CW Doppler<br>processing. Supporting Linear, Curve<br>linear, Phase array and<br>Pencil probes. Cine play back capability Image file archive Software upgrade with USB<br>flash drive. Digital multi-beam forming | | | |
| Product Name<br>(K number) | Predicate Device<br>Voluson E8/E8Expert<br>K101236 | CHISON<br>iVis60EXPERT,Q6/Q8,i7<br>K120801 | Submission Device<br>Q Series & i7,i8,i9<br>TBD | Remark |
| Operating<br>Controls | TGC 8 slider | TGC 8 slider | TGC 8 slider | Same |
| | Depth Range: 0 to 30 cm | Depth Range:0~30cm | Depth Range:0~30cm | Same |
| | 256 shades of gray | 256 shades of gray | 256 shades of gray | Same |
| | Image Reverse: Right/Left | Image Reverse: Right/Left | B orientation flip: L/R ,U/D | Same |
| | B persistence: 8 steps | B persistence: 7 steps | B persistence:0~7 | SE Analysis1 |
| | Frequency Selection:3 steps | Frequency Selection:5 steps | Frequency Selection:5 steps | SE Analysis1 |
| | PW Sweep Speed:3 Steps | PW Sweep Speed:3 Steps | PW Sweep Speed:3 Steps | Same |
| | Angle Correction: ± 0-85°, 1° step | Angle Correction: ± 0-72°, 5 step | Angle Correction: ± 0-80°, 5 step | SE Analysis1 |
| | Steered Linear: 0° -25° | Steered Linear:: 0- 20° | Steered Linear:: -20°-20° | SE Analysis1 |
| | Spectrum Inversion | Spectrum Inversion | Spectrum Inversion | Same |
| | Acoustic Power Range: 1-100 | Acoustic Power Range:1-100 | Acoustic Power Range:1-100 | Same |
| | Doppler Auto Trace | Doppler Auto Trace | Doppler Auto Trace | Same |
| | Color Maps: 8 maps | Color Maps: 8 maps | Color Maps: 9 maps | SE Analysis1 |
| | CFM Spectrum Inversion | CFM Spectrum Inversion | CFM Spectrum Inversion | Same |
| | PD Color Maps: 8 maps | PD Color Maps: 4 maps | PD Color Maps: 9 maps | SE Analysis1 |
| | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Freeze control: Toggling freeze key | Same |
| | Color ROI setting: trackball and set<br>key to control size and position | Color ROI setting: trackball and set key to control size and<br>position | Color ROI setting: trackball and set key to control size and<br>position | Same |
| Product Name<br>(K number) | Predicate Device<br>Voluson E8/E8Expert<br>K101236 | CHISON<br>iVis60EXPERT,Q6/Q8,i7<br>K120801 | Submission Device<br>Q Series & i7,i8,i9<br>TBD | Remark |
| | Zoom adjustable | Zoom adjustable | Zoom adjustable | Same |
| | Cine control : play backward ,play continuously | Cine control : play backward ,play continuously | Cine control : play backward ,play continuously | Same |
| Safety<br>Compliance | IEC60601-1 Medical electrical<br>equipment - Part 1: General<br>requirements for safety | IEC60601-1 Medical electrical<br>equipment - Part 1: General<br>requirements for safety | IEC60601-1 Medical electrical<br>equipment - Part 1: General<br>requirements for safety | |
| | IEC60601-1-2 Medical electrical<br>equipment - Part 1-2: General<br>requirements for safety - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements and tests | IEC60601-1-2 Medical electrical<br>equipment - Part 1-2: General<br>requirements for safety -<br>Collateral standard:<br>Electromagnetic compatibility -<br>Requirements and tests | IEC60601-1-2 Medical electrical<br>equipment - Part 1-2: General<br>requirements for safety -<br>Collateral standard:<br>Electromagnetic compatibility -<br>Requirements and tests | |
| | IEC60601-2-37 Medical electrical<br>equipment - Part 2-37: Particular<br>requirements for the safety of<br>ultrasonic medical diagnostic and<br>monitoring equipment | IEC60601-2-37 Medical<br>electrical equipment - Part 2-37:<br>Particular requirements for the<br>safety of ultrasonic medical<br>diagnostic and monitoring<br>equipment | IEC60601-2-37 Medical<br>electrical equipment - Part 2-37:<br>Particular requirements for the<br>safety of ultrasonic medical<br>diagnostic and monitoring<br>equipment | Same |
| | ISO 10993-5 Biological evaluation of<br>medical devices - Part 5: Tests for in<br>vitro cytotoxicity | ISO 10993-5 Biological | ISO 10993-5 Biological<br>evaluation of medical devices -<br>Part 5: Tests for in vitro<br>cytotoxicity | |
| | ISO 10993-10 Biological evaluation<br>medical devices - Part 10: Tests for<br>imitation and delayed-type<br>hypersensitivity | | ISO 10993-10 Biological<br>evaluation of medical devices -<br>Part 10: Tests for imitation and<br>delayed-type hypersensitivity | |

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510(K) Submission

510(k) Summary

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510(k) Summary

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510(K) Submission

Chison Medical Imaging Co.. Ltd.

SUBMISSION

Emission

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510(K) Submission

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| | Predicate Device | | Submission Device | Remark | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | CHISON | Q Series & i7,i8,i9 | | |
| | Product Name Voluson E8/E8Expert<br>(K number) K101236 | iVis60EXPERT,Q6/Q8,i7<br>K120801 | TBD | | |
| Patient<br>Contact<br>Materials | Bio-compatible | Bio-compatible | Bio-compatible | Same | |
| Scanning<br>Mode | Electronic Sector<br>Electronic Convex<br>Electronic Linear<br>Mechanic Volume Sweep | Electronic Sector<br>Electronic Convex<br>Electronic Linear<br>Mechanic Volume Sweep | Electronic Sector<br>Electronic Convex<br>Electronic Linear<br>Mechanic Volume Sweep | | |
| Operation<br>Mode | B, M (Conventional M), PW, CFM (Color Flow Doppler Mode), PD (Power Doppler Mode), TD (Tissue Doppler Mode), B + Power Doppler Mode, B + CFM Doppler Mode, Automatic Tissue Optimization, SRI II (Speckle reduction imaging), Real-time automatic Doppler calculations, Patient information database, Image Archive on hard drive, 2D-ModeM-Mode (conventional M-Mode), AMM (Anatomical M-Mode), PW Doppler Mode, CW Doppler Mode, High PRF Doppler Mode, Color Flow Doppler Mode (CFM), Power Doppler Mode (PD), HD-Flow Doppler Mode (HD-Flow), Tissue Doppler Mode (TD), M-Color Flow Modes, Elastography, Volume Modes (3D/4D) | B, M (Conventional M), PW, CFM (Color Flow Doppler Mode), PD (Power Doppler Mode), TD (Tissue Doppler Mode), B + Power Doppler Mode, B + CFM Doppler Mode, AIO, SRA, Real-time automatic Doppler calculations, Patient information database, Image Archive on hard | B, M (Conventional M), PW,CFM (Color Flow Doppler Mode), PD (Power Doppler Mode), TD (Tissue Doppler Mode), B + Power Doppler Mode, B + CFM Doppler Mode, AIO, SRA, Real-time automatic Doppler calculations, Patient information database, Image Archive on hard drive, 2D-ModeM-Mode (conventional M-Mode), Free steering M mode, PW Doppler Mode, CW Doppler Mode, High PRF Doppler Mode, Color Flow Doppler Mode (CFM), Power Doppler Mode (PD), Tissue Doppler Mode (TDI), Color M Volume Modes (3D/4D) | Same | |
| | Product Name<br>(K number) | Predicate Device | | Submission Device | Remark |
| | Voluson E8/E8Expert<br>K101236 | | CHISON<br>iVis60EXPERT,Q6/Q8,i7<br>K120801 | Q Series & i7,i8,i9<br>TBD | |
| Display | Display Modes<br>B, B/M, M, Dual mode, Quad<br>mode, 2D Steer, CFM, PW,CW, AMM<br>(Anatomical M-Mode), HPRF, TDI,<br>M-Color Flow Modes, Curved<br>Panoramic Imaging, Trapezoidal<br>image, compound, SRI II (Speckle<br>reduction imaging), Elastography,<br>Real time Triplex capability | | B, B/M, M, Dual mode, Quad<br>mode, 2D Steer, CFM, PW, CW,<br>Free Steering M mode, HPRF,<br>TDI, Color M, Curved<br>Panoramic Imaging,<br>Trapezoidal image, compound,<br>SRA, Real time Triplex<br>capability | B, B/M, M, Dual mode, Quad<br>mode, 2D Steer, CFM, PW, CW,<br>Free Steering M mode, HPRF,<br>TDI, Color M, Curved<br>Panoramic Imaging,<br>Trapezoidal image, compound,<br>SRA, Elastography, Real time<br>Triplex capability | Same |
| | Display<br>Annotations | | Patient name ;ID; Hospital<br>Name; Date; Time; date; year;<br>Application Name; Gray Scale<br>bar; Frame Rate; Zoom Factor;<br>TGC curve; Cine Frame<br>Number; Recorder Status;<br>Measurement<br>Results ;Displayed Acoustic | Patient name ; ID;<br>Hospital Name; Time; Date;<br>Probe Name; Application Name;<br>Gray Scale bar; Frame Rate;<br>Elastography mode; TGC<br>curve; Cine Frame Number;<br>Recorder Status;<br>Measurement Results; Power<br>output%; Biopsy Guide Line;<br>ECG Line; M-Mode/Freeze<br>Steering-M Mode; Doppler<br>Mode; Color Flow Imaging<br>Modes; 3D/4D Mode; Zoom<br>overview image (zoom box<br>position); Logo; Trackball<br>function; | Same |
| | Patient name ;ID;<br>Hospital Name; Time; Date; Probe<br>Name; Application Name; Gray Scale<br>bar; Frame Rate; Elastography<br>mode; TGC curve ;Cine Frame<br>Number; Recorder Status;<br>Measurement Results; Power<br>output% ;Biopsy Guide Line; ECG<br>Line; M-Mode/Freeze Steering-M<br>Mode; Doppler Mode; Color Flow<br>Imaging Modes; 3D/4D Mode; Zoom<br>overview image (zoom box position);<br>Logo; Trackball function; | | Output; Power output% ;Biopsy<br>Guide Line; ECG Line | | |
| Display | 19" high-resolution LCD monitor | | | 19" LCD high-resolution monitor<br>for i7/i8/i9<br>SE Analysis2<br>for i7 | |
| | Predicate Device | | Submission Device | Remark | |
| | | CHISON | Q Series & i7,i8,i9 | | |
| | Product Name Voluson E8/E8Expert<br>(K number) K101236 | iVis60EXPERT,Q6/Q8,i7<br>K120801 | TBD | | |
| Monitor | | 15" LCD high-resolution monitor<br>for iVis 60/iVis | 15" LCD high-resolution monitor<br>for Q6/Q8/Q9/Q10 | | |
| | Measurements Distance; Area(Ellipse); Volume;<br>Ratio; Angle; M Distance; M Time;<br>Velocity; HR; Vs; Vd; Vmean; PI;RI;<br>SD; GYN, OB, Vessel, URO, Small<br>Parts, Pediatrics, Carotid, Cardiac and<br>Abdomen package | Distance; Area(Ellipse);<br>Volume; Ratio; Angle; M<br>Distance; M Time; Velocity; HR;<br>Vs; Vd; Vmean; PI;RI; SD; GYN,<br>OB, Vessel, URO, Small Parts,<br>Pediatrics, Carotid, Cardiac and<br>Abdomen package | Distance; Area(Ellipse);<br>Volume; Ratio; Angle; M<br>Distance; M Time; Velocity; HR;<br>Vs; Vd; Vmean; PI;RI; SD; GYN, Same<br>OB, Vessel, URO, Small Parts,<br>Pediatrics, Carotid, Cardiac and<br>Abdomen package | | |
| Transducer<br>Types &<br>Connectors | Convex Array, Micro convex Array,<br>Sector Phased Array, Linear Array,<br>Volume probe, Pencil probe<br>4 ports. | Convex Array, Linear Array,<br>Sector Phase array, Volume<br>probe<br>i7: 4 ports<br>iVis 60/iVis 60EXPERT : 3<br>ports<br>Q8/Q6: 2 ports | Convex Array, Micro convex<br>Array, Linear Array, Sector<br>Phase array, Volume probe,<br>Pencil probe<br>i7/i8/i9: 4 ports<br>Q10/Q9/Q8/Q6: 2 ports | SE Analysis3 | |
| Principle of<br>Operation | Applying high voltage burst to the<br>Piezoelectric material in the<br>transducer and detect the reflected<br>echo to construct the 2D, 3D/4D mode,<br>Doppler color, and Doppler spectrum<br>image for diagnostic purpose. | Applying high voltage burst to<br>the Piezoelectric material in the<br>transducer and detect the<br>reflected echo to construct the<br>2D, 3D/4D mode, Doppler color,<br>and Doppler spectrum image for<br>diagnostic purpose. | Applying high voltage burst to<br>the Piezoelectric material in the<br>transducer and detect the<br>reflected echo to construct the<br>2D, 3D/4D mode, Doppler color,<br>forand Doppler spectrum image for<br>diagnostic purpose. | Same | |
| Users / Sites | Hospitals, clinics usage | | Hospitals, clinics usage | Same | |
| Acoustic<br>Output | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm² maximum | | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm² | Same | |
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