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 Description

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.

AI/ML Overview

The provided 510(k) submission for the CHISON Q Series & i7, i8, i9 Diagnostic Ultrasound System primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study proving those criteria are met in the way requested.

The submission claims substantial equivalence by showing that the proposed device has the same intended use, basic operating modes, and similar design principles as the predicate devices (GE Voluson E6/E8/E8 Expert K101236 and CHISON iVis60EXPERT, Q6/Q8, i7 K120801). The "Modifications and Newly Added Features" (new transducers and software options) are also claimed to be substantially equivalent.

No explicit acceptance criteria or a dedicated performance study against such criteria are presented in the document. Instead, the device's conformance to safety standards and comparison to predicate device specifications are used as the basis for demonstrating safety and effectiveness.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, no explicit acceptance criteria for individual performance metrics (e.g., sensitivity, specificity, accuracy for a specific diagnostic task) are defined or reported. The "acceptance criteria" in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant safety standards.

Feature / Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Indications for Use	Same as predicate devices	"Same" as predicate (Voluson E8/E8Expert K101236 and CHISON iVis60EXPERT, Q6/Q8, i7 K120801)
Operating Modes	Same as predicate devices	"Same" as predicate (predicates offer B, M, PW, CFM, PD, TD, etc.; submission device adds new modes like 2D Steer, Elastography, Curved Panoramic Imaging, Supper needle, IMT) - claimed substantially equivalent despite additions.
Safety Compliance	Conform to specific IEC and ISO standards	Conformity to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD3, ISO 10993-1 (biocompatibility).
Acoustic Output	Max Derated Ispta: 720mW/cm² (Track 3); MI: 1.9 (Track 3)	Derated Ispta: 720mW/cm² maximum (Track 3); Mechanical Index: 1.9 maximum (Track 3)
Biocompatibility	Bio-compatible (claimed by predicate)	Bio-compatible (claimed by submission device)
Performance with New Transducers/Software	Substantially equivalent to predicate performance	"The results show that these modifications are substantially equivalent to the predicate devices." (No specific metrics provided).
Image Reverse	Range compatible with clinical needs	Predicate: Right/Left; Submission: B orientation flip: L/R, U/D (Claimed SE)
B persistence	Range compatible with clinical needs	Predicate (Voluson): 8 steps; Predicate (CHISON): 7 steps; Submission: 0-7 (Claimed SE)
Frequency Selection	Range compatible with clinical needs	Predicate (Voluson): 3 steps; Predicate (CHISON): 5 steps; Submission: 5 steps (Claimed SE)
Angle Correction	Range compatible with clinical needs	Predicate (Voluson): ± 0-85°, 1° step; Predicate (CHISON): ± 0-72°, 5 step; Submission: ± 0-80°, 5 step (Claimed SE)
Steered Linear	Range compatible with clinical needs	Predicate (Voluson): 0°-25°; Predicate (CHISON): 0-20°; Submission: -20°-20° (Claimed SE)
Color Maps	Sufficient for clinical visualization	Predicate (Voluson/CHISON): 8 maps; Submission: 9 maps (Claimed SE)
PD Color Maps	Sufficient for clinical visualization	Predicate (Voluson): 8 maps; Predicate (CHISON): 4 maps; Submission: 9 maps (Claimed SE)
Monitor Size	Clinically acceptable	Predicate (Voluson): 19" LCD; Predicate (CHISON): 15" LCD; Submission: 19" LCD for i7/i8/i9, 15" LCD for Q6/Q8/Q9/Q10 (Claimed SE)
Transducer Connectors	Sufficient for clinical functions	Predicate (Voluson): 4 ports; Predicate (CHISON i7): 4 ports; Other CHISON: 2-3 ports; Submission: i7/i8/i9: 4 ports, Q10/Q9/Q8/Q6: 2 ports (Claimed SE)
Power Supply	Comply with safety standards	Predicate (Voluson): AC: 100-240V; Predicate (CHISON): AC: 220-240V, 100V, 115-130V; Submission: AC: 100-240V (Complies with IEC 60601-1, 60601-1-2)

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

No specific "test set" in the context of diagnostic performance (e.g., images for measuring sensitivity/specificity) is described. The conformity assessment for the device relies on laboratory testing against engineering specifications and safety standards, as well as a comparison to predicate devices.
Data Provenance: Not applicable as no diagnostic performance test set is described.

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

Not applicable. No diagnostic performance study involving expert-established ground truth is presented.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic performance test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence to pre-existing ultrasound systems based on technical specifications and safety standards, not on assessing the improvement in human reader performance with or without AI assistance. The new software options (Elastography, IMT, Curved Panoramic, Supper needle) are listed as features, but no clinical efficacy data for them is provided.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done. The device is a diagnostic ultrasound system, not an AI-only algorithm. The "newly added software options" are features of the ultrasound system, and their performance is subsumed under the general claim of substantial equivalence, without specific standalone performance metrics.

7. Type of Ground Truth Used

Not applicable. For this type of 510(k) submission, "ground truth" related to diagnostic accuracy (e.g., pathology, outcomes data, expert consensus on disease presence) is not typically required or provided unless the device makes a new or significantly modified diagnostic claim that deviates from established predicate devices. The basis for safety and effectiveness is compliance with recognized standards and comparison to a legally marketed equivalent device.

8. Sample Size for the Training Set

Not applicable. The submission does not describe an AI or machine learning component that would require a "training set" in the conventional sense for diagnostic performance.

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

Not applicable. No training set is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is primarily a non-clinical performance evaluation and a substantial equivalence comparison to predicate devices.

Non-Clinical Performance Evaluation: This involved laboratory testing to verify that the system (including new transducers) met all design specifications. This testing also confirmed conformity to various medical device safety standards:
- IEC 60601-1: 2005 (General Requirements for Safety)
- IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
- IEC 60601-2-37: 2007 (Particular Requirements for Ultrasonic Equipment Safety)
- NEMA UD 2-2004 (Acoustic Output Measurement)
- NEMA UD3: 2004 (Real-time Display of Acoustic Output Indices)
- ISO 10993-1 (Biological Evaluation of Medical Devices - Biocompatibility)
Substantial Equivalence Comparison (to K101236 and K120801): The submission provides a detailed comparison table (Table 1) highlighting similarities in:
- Indications for Use
- Design principles (e.g., autocorrelation for color processing, FFT for Doppler)
- Operating Controls (e.g., TGC 8 slider, Depth Range, shades of gray)
- Safety Compliance (adherence to the same IEC/ISO standards)
- Patient Contact Materials (Bio-compatible)
- Scanning Modes (Electronic Sector, Convex, Linear, Mechanic Volume Sweep)
- Operation Modes (B, M, PW, CFM, PD, TD, 3D/4D, etc., including newly added features like Elastography/Curved Panoramic)
- Display characteristics and annotations
- Monitor specifications
- Measurement packages
- Transducer Types & Connectors
- Principle of Operation (high voltage burst to piezoelectric material, reflected echo detection)
- Acoustic Output (matching the predicate's stated maximums for MI and Ispta)

The conclusion drawn from this comparison is that any differences are minor and do not affect the basic design, usage, effectiveness, or safety, thereby establishing substantial equivalence. No clinical testing was required or performed for this submission.

Summary

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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

Date of submission : January 12, 2014

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

Contact:	Ms. Ruoli Mo
Tel:	+86-510-85311707, 85310593	Fax: +86-510-85310726
U.S. Agent:	Leiker Regulatory & Quality Consulting
	7263 Cronin Circle
	Dublin, CA 94568
Contact:	Bob Leiker
Tel:	(925) 719-1946	Fax: (866) 718-3819

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 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:

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

Product Name(K number)	Predicate Device	CHISONiVis60EXPERT,Q6/Q8,i7K120801	Submission DeviceQ Series & i7,i8,i9TBD	Remark
Indicationsfor Use	Voluson E8/E8ExpertK101236	Fetal (Obstetrics);Abdomen;Small Organ (Thyroid, testesand breast etc);Cardiac (adult and pediatric);Musculo-skeletal(Conventional and Superficial);Peripheral Vascular,Transvaginal,OB/Gyn and Urology.	Fetal (Obstetrics);Abdomen;Pediatric;Small Organ (Thyroid, testes andbreast);Cardiac (adult and pediatric);Musculo-skeletal (Conventional andSuperficial);Peripheral Vascular,Transvaginal,OB/Gyn and Urology.	Same
	Fetal (Obstetrics);Abdominal (including GYN, pelvicand infertility monitoring/follicledevelopment); Pediatric;Small Organ (breast, testes, thyroidetc); Neonatal and Adult Cephalic;Cardiac (adult and pediatric);Musculo-skeletal Conventional andSuperficial;Peripheral Vascular;Transrectal;Transvaginal and Intraoperative(abdominal, PV and neurological).	Autocorrelation for colorprocessing, and FFT forpulse and CW Dopplerprocessing. Supporting Linear, Curvelinear, Phase array andPencil probes. Cine play back capability Image file archive Software upgrade withUSB flash drive. Digital multi-beamforming	Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing. Supporting Linear, Curvelinear, Phase array andPencil probes. Cine play back capability Image file archive Software upgrade with USBflash drive. Digital multi-beam forming	Same
Design	Autocorrelation for colorprocessing and FFT forpulse and CW Dopplerprocessing. Supporting Linear, Curvelinear, Phase array andPencil probes. Cine play back capability Image file archive Software upgrade with USBflash drive. Digital multi-beam forming
Product Name(K number)	Predicate DeviceVoluson E8/E8ExpertK101236	CHISONiVis60EXPERT,Q6/Q8,i7K120801	Submission DeviceQ Series & i7,i8,i9TBD	Remark
OperatingControls	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 setkey to control size and position	Color ROI setting: trackball and set key to control size andposition	Color ROI setting: trackball and set key to control size andposition	Same
Product Name(K number)	Predicate DeviceVoluson E8/E8ExpertK101236	CHISONiVis60EXPERT,Q6/Q8,i7K120801	Submission DeviceQ Series & i7,i8,i9TBD	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
SafetyCompliance	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safety	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safety	IEC60601-1 Medical electricalequipment - Part 1: Generalrequirements for safety
	IEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety - Collateralstandard: Electromagneticcompatibility - Requirements and tests	IEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety -Collateral standard:Electromagnetic compatibility -Requirements and tests	IEC60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for safety -Collateral standard:Electromagnetic compatibility -Requirements and tests
	IEC60601-2-37 Medical electricalequipment - Part 2-37: Particularrequirements for the safety ofultrasonic medical diagnostic andmonitoring equipment	IEC60601-2-37 Medicalelectrical equipment - Part 2-37:Particular requirements for thesafety of ultrasonic medicaldiagnostic and monitoringequipment	IEC60601-2-37 Medicalelectrical equipment - Part 2-37:Particular requirements for thesafety of ultrasonic medicaldiagnostic and monitoringequipment	Same
	ISO 10993-5 Biological evaluation ofmedical devices - Part 5: Tests for invitro cytotoxicity	ISO 10993-5 Biological	ISO 10993-5 Biologicalevaluation of medical devices -Part 5: Tests for in vitrocytotoxicity
	ISO 10993-10 Biological evaluationmedical devices - Part 10: Tests forimitation and delayed-typehypersensitivity		ISO 10993-10 Biologicalevaluation of medical devices -Part 10: Tests for imitation anddelayed-type hypersensitivity

: 510(k) Summary

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510(K) Submission

510(k) Summary

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510(k) Summary

510(K) Submission

Chison Medical Imaging Co.. Ltd.

SUBMISSION

Emission

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1
11=

510(K) Submission

	Predicate Device		Submission Device	Remark
		CHISON	Q Series & i7,i8,i9
	Product Name Voluson E8/E8Expert(K number) K101236	iVis60EXPERT,Q6/Q8,i7K120801	TBD
PatientContactMaterials	Bio-compatible	Bio-compatible	Bio-compatible	Same
ScanningMode	Electronic SectorElectronic ConvexElectronic LinearMechanic Volume Sweep	Electronic SectorElectronic ConvexElectronic LinearMechanic Volume Sweep	Electronic SectorElectronic ConvexElectronic LinearMechanic Volume Sweep
OperationMode	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(K number)	Predicate Device		Submission Device	Remark
	Voluson E8/E8ExpertK101236		CHISONiVis60EXPERT,Q6/Q8,i7K120801	Q Series & i7,i8,i9TBD
Display	Display ModesB, B/M, M, Dual mode, Quadmode, 2D Steer, CFM, PW,CW, AMM(Anatomical M-Mode), HPRF, TDI,M-Color Flow Modes, CurvedPanoramic Imaging, Trapezoidalimage, compound, SRI II (Specklereduction imaging), Elastography,Real time Triplex capability		B, B/M, M, Dual mode, Quadmode, 2D Steer, CFM, PW, CW,Free Steering M mode, HPRF,TDI, Color M, CurvedPanoramic Imaging,Trapezoidal image, compound,SRA, Real time Triplexcapability	B, B/M, M, Dual mode, Quadmode, 2D Steer, CFM, PW, CW,Free Steering M mode, HPRF,TDI, Color M, CurvedPanoramic Imaging,Trapezoidal image, compound,SRA, Elastography, Real timeTriplex capability	Same
	DisplayAnnotations		Patient name ;ID; HospitalName; Date; Time; date; year;Application Name; Gray Scalebar; Frame Rate; Zoom Factor;TGC curve; Cine FrameNumber; Recorder Status;MeasurementResults ;Displayed Acoustic	Patient name ; ID;Hospital Name; Time; Date;Probe Name; Application Name;Gray Scale bar; Frame Rate;Elastography mode; TGCcurve; Cine Frame Number;Recorder Status;Measurement Results; Poweroutput%; Biopsy Guide Line;ECG Line; M-Mode/FreezeSteering-M Mode; DopplerMode; Color Flow ImagingModes; 3D/4D Mode; Zoomoverview image (zoom boxposition); Logo; Trackballfunction;	Same
	Patient name ;ID;Hospital Name; Time; Date; ProbeName; Application Name; Gray Scalebar; Frame Rate; Elastographymode; TGC curve ;Cine FrameNumber; Recorder Status;Measurement Results; Poweroutput% ;Biopsy Guide Line; ECGLine; M-Mode/Freeze Steering-MMode; Doppler Mode; Color FlowImaging Modes; 3D/4D Mode; Zoomoverview image (zoom box position);Logo; Trackball function;		Output; Power output% ;BiopsyGuide Line; ECG Line
Display	19" high-resolution LCD monitor			19" LCD high-resolution monitorfor i7/i8/i9SE Analysis2for i7
	Predicate Device		Submission Device	Remark
		CHISON	Q Series & i7,i8,i9
	Product Name Voluson E8/E8Expert(K number) K101236	iVis60EXPERT,Q6/Q8,i7K120801	TBD
Monitor		15" LCD high-resolution monitorfor iVis 60/iVis	15" LCD high-resolution monitorfor Q6/Q8/Q9/Q10
	Measurements Distance; Area(Ellipse); Volume;Ratio; Angle; M Distance; M Time;Velocity; HR; Vs; Vd; Vmean; PI;RI;SD; GYN, OB, Vessel, URO, SmallParts, Pediatrics, Carotid, Cardiac andAbdomen package	Distance; Area(Ellipse);Volume; Ratio; Angle; MDistance; M Time; Velocity; HR;Vs; Vd; Vmean; PI;RI; SD; GYN,OB, Vessel, URO, Small Parts,Pediatrics, Carotid, Cardiac andAbdomen package	Distance; Area(Ellipse);Volume; Ratio; Angle; MDistance; M Time; Velocity; HR;Vs; Vd; Vmean; PI;RI; SD; GYN, SameOB, Vessel, URO, Small Parts,Pediatrics, Carotid, Cardiac andAbdomen package
TransducerTypes &Connectors	Convex Array, Micro convex Array,Sector Phased Array, Linear Array,Volume probe, Pencil probe4 ports.	Convex Array, Linear Array,Sector Phase array, Volumeprobei7: 4 portsiVis 60/iVis 60EXPERT : 3portsQ8/Q6: 2 ports	Convex Array, Micro convexArray, Linear Array, SectorPhase array, Volume probe,Pencil probei7/i8/i9: 4 portsQ10/Q9/Q8/Q6: 2 ports	SE Analysis3
Principle ofOperation	Applying high voltage burst to thePiezoelectric material in thetransducer and detect the reflectedecho to construct the 2D, 3D/4D mode,Doppler color, and Doppler spectrumimage for diagnostic purpose.	Applying high voltage burst tothe Piezoelectric material in thetransducer and detect thereflected echo to construct the2D, 3D/4D mode, Doppler color,and Doppler spectrum image fordiagnostic purpose.	Applying high voltage burst tothe Piezoelectric material in thetransducer and detect thereflected echo to construct the2D, 3D/4D mode, Doppler color,forand Doppler spectrum image fordiagnostic purpose.	Same
Users / Sites	Hospitals, clinics usage		Hospitals, clinics usage	Same
AcousticOutput	Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm² maximum		Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm²	Same

	redicate Device		mission Devic	Remar
	roduct Name Voluson E8/E8Expert (K number) K101236	CHISON	Series & i7,i8,i5
		Vis60EXPERT,Q6/Q8,i7	TBD
		K120801
	S/TIB/TIC:0.1-4.0 Range,	haximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical Index: 1.9 Taximum, or Derated Isppa: 1aximum, or Derated Isppa: 190 W/cm² max	maximum, TIS/TiB/TIC:0.1- Range, Mechanical Index: 1 Maximum, or Derated Isppa 190 W/cm² max

	lechanical Index: 1.9 Maximum, or erated Isppa: 190 W/cm² max

			ower requirements C :100V- 240V,

	Power		requenzy:50-60Hz perating temperature: 10-40° ; relative humidity
		Operating temperature: 10-40° C; relative humidity 30-75%;Barometric		SE Analysis4

			-75%;Barometi
		essure:700 to 1060 hPa	ssure:700 to 1060 h
Peripherals	Remote BW Printer, Remote Colo Printer, Remote DVR, Footswitch, VGA OUT, Network, USB,SS-Video ,DVI-D out, Audio	Q8/Q6:
and		LAN port, Footswitch ,USB flast mobile drive, VGA output ,S-video, Remote VGA Printer, USB Printer,
Accessories

	out,RS232
		S-Video		Same
		i7:
		LAN port, Footswitch ,USB flass mobile drive, VGA output ,S-video, Remote Video Printer, USB Printer,



		S-Video .

510(k) Summary

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510(k) Summary

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Chison Medical Imaging Co., Ltd.

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510(K) Submission

510(k) Summary

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510(k) Summary

510(K) Submission

Chison Medical Imaging Co., Ltd.

Stock (Submissions)

submission

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Comparison Analysis

SE Analysis 1

The Operating Controls item of proposed device and the predicate device are with different Image Reverse/Frequency Selection/Angle Correction/Steered Linear/Color Maps/PD Color Maps, but they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

SE Analysis 2

The screen size of the proposed is smaller than that of the E8. This difference is considered to have no effect on effectiveness and safety.

SE Analysis 3

The Transducer Connectors of the proposed is less than that of the E8. This difference is considered to have no effect on effectiveness and safety.

SE Analysis 4

The Power Supply of the proposed device and the predicate device are AC: 100V- 240V and AC: 220V - 240V; 100V, 115V - 130 V respectively, but both of them comply with IEC60601-1 and IEC 60601-1-2. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.

Discussion of Substantially Equivalent

The subject device has same intended use, same product design, same performance effectiveness, and performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device.

11. Substantially Equivalent Conclusion:

I n accordance with the Federal Food Drug and Cosmetic Act. 21 CFR Part 807 and based on the information provided in this premarket notification, Chison Medical Imaging Co., Ltd. concludes that the CHISON Q Series and i7, i8, i9 Diagnostic Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

June 2, 2014

Chison Medical Imaging Co., Ltd. % Mr. Bob Leiker Leiker Regulatory & Quality 7263 Cronin Circle DUBLIN CA 94568

Re: K140364

Trade/Device Name: Q Series & i7, i8, i9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 15, 2014 Received: April 18, 2014

Dear Mr. Leiker:

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. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Q Series & i7, i8, i9 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

D3C60L. Convex Array D3C60L-C, Convex Array D7L40L-C, Linear Array D12L40L. Linear Array D6C12L, Micro Convex Array D7C10L-C, Micro Convex Array D5C20L, Micro Convex Array D3C20L, Micro Convex Array D6C15L-A, Micro Convex Array D3C60L-B, Convex Array D7L40L, Linear Array D7L60L, Linear Array D7L30L. Linear Array D7C10L, Micro Convex Array V6C10L, Volume Probe D5C20L-A, Micro Convex Array D6C15L, Micro Convex Array D3P64L, Phased Array

{12}------------------------------------------------

Page 2-Mr. Leiker

D6P64L, Phased Array V4C40L, Volume probe D2D16L, Pencil Array V4C40L-C, Volume Probe

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sm. 7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K140364

Device Name

Q Series & i7, i8, i9 Diagnostic Ultrasound Systems

Indications for Use (Describe)

The device is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatic; Small Organ (breast, testes, thyroid); Cardisc (salaric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

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)

Please do not write below this line – continue on a separate page if needed.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

aca (10) 64) 474 PSC Pub

{14}------------------------------------------------

Diagnostic Ultrasound Indications For Use

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P	P	P	3,5
	Abdominal	P	P	P		P	P	P	P	3,4,5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	P	4.5
	Small Organ" (Specify)	P	P	P		P	P	P	P	4.5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P	P	3.4.5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	P	4.5
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	P	4,5
	Other (Urology)	P	P	P		P	P	P	P	4,5
	Other (Ob/GYN)	P	P	P	P	P	P	P	P	5
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	P	5
	Cardiac Pediatric	P	P	P	P	P	P	P	P	5
Peripheral Vessel	Peripheral vessel	P	P	P		P	P	P	P	5

E = added under this appendix P = previously cleared by FDA; N = new indication;

Note : 1. Combined modes are B/M, B/Color M, B/PWD or CWD. B/Color/PWD or CWD,B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode 4.Elastography imaging

Includes imaging of guidance of biopsy (Super needle)

Over-The-Counter Use AND/OR Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{15}------------------------------------------------

Q Series & 17, i8, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D3C60L, Convex Array

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P	P	5
	Abdominal	P	P	P	P	P	P	P	P	4,5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	P	P	P	P	P	P	P	P	4.5
	Other (Ob/GYN)	P	P	P	P	P	P	P	P	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

new indication; Note : I. Combined modes are B/M, B/Color M, B/PWD or CWD. B/Color/PWD or CWD,B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

Indications For Use

{16}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D3C60L-B, Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
--------------------------------------------------------------------------------------------------

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N	N	N	5
	Abdominal	N	N	N	N	N	N	N	N	4.5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ"" (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	N	4.5
	Other (Ob/GYN)	N	N	N	N	N	N	N	N	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

E = added under this appendix P = previously cleared by FDA: N = new indication;

Note : I . Combined modes are BM. B+PWD : B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K101236, K120801

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{17}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D3C60L-C, Convex Array

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
	Ophthalmic
Ophthalmic	Fetal	N	N	N	N	N	N	N	N	5
Fetal Imaging &Other	Abdominal	N	N	N	N	N	N	N	N	4,5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	N	4.5
	Other (Ob/GYN)	N	N	N	N	N	N	N	N	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

E = added under this appendix P = previously cleared by FDA; N = new indication; Note : I. Combined modes are BM, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236. K 120801

AND/OR Over-The-Counter Use × Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{18}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D7L40L, Linear Array

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	P	4,5
	Small Organ" (Specify)	P	P	P		P	P	P	P	4,5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	P	4,5
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	N	4.5
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel	P	P	P		P	P	P	P	5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

E = added under this appendix N = new indication; P = previously cleared by FDA: Nole : I . Combined modes are BM. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/41) Imaging Mode

Elastography imaging
Includes imaging of guidance of biopsy (Super needle)

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{19}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D7L40L-C, Linear Array

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	N	4.5
	Small Organ (Specify)	N	N	N	N	N	N	N	N	4.5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	N	4,5
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	N	4.5
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel	N	N	N	N	N	N	N	N	5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

P = previously cleared by FDA: E = added under this appendix N = new indication; Note : I. Combined modes are B/M, B/Color M. B/PWD or CWD. B/Color/PWD or CWD,B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy (Super needle)

Predicate transducer (K number): K 101236. K 120801

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

Page 7 of 24

{20}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D7L60L, Linear Array

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	P	4,5
	Small Organ1 (Specify)	P	P	P		P	P	P	P	4,5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	P	4.5.
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	N	4.5
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel	P	P	P		P	P	P	P	5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

P = previously cleared by FDA; E = added under this appendix N = new indication; Note : 1. Combined modes are B/M, B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy (Super needle)

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{21}------------------------------------------------

Q Series & i7, i8, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D12L40L, Linear Array

	Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	N	4.5
	Small Organ"" (Specify)	N	N	N		N	N	N	N	4.5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	N	4.5
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	N	4.5
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	N	5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

P = previously cleared by FDA: E = added under this appendix N = new indication; Note : I . Combined modes are B/M. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PW/D 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy (Super needle)

Predicate transducer (K number): K101236

AND/OR Over-The-Counter Use Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of in Vitro Diagnostic and Radiological Health 210(k)

Page 9 of 24

{22}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D7L30L, Linear Array

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ" (Specify)	N	N	N	N	N	N	N	N	4.5
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	P	4.5
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	P	4.5
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	N	5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B/M. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast. testes, thyroid

Small Organ, Breast, Testis
B/W/US Imaging Mode

3.3D/40 Imaging Mode 4.Flastography imaging

Includes imaging of guidance of biopsy (Super needle)

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{23}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D6C12L, Micro Convex Array

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
--	--------------------------------------------------------------------------------------------------

	Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ "(Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P	P	4.5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	P	P	P		P	P	P	P	4.5
	Other (Ob/GYN)	P	P	P		P	P	P	P	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

E = added under this appendix P = previously cleared by FDA; N = new indication:

Note : 1. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(k)

{24}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D7C10L, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(1) (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	P	P	P	4,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	P	P	P		P	P	P	P	4.5
	Other (Ob/GYN)	P	P	P		P	P	P	P	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA: E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{25}------------------------------------------------

Q Series & 17, 18, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

System: Q6/Q8/Q9/Q10, 17/i8/i9 Diagnostic Ultrasound Systems Transducer: D7C10L-C, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ11 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	N	4,5
	Trans-urethral								N
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	N	4,5
	Other (Ob/GYN)	N	N	N		N	N	N	N	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

E = added under this appendix N = new indication; P = previously cleared by FDA;

Note : 1. Combined modes are B/M. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Flastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236. K 120801

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

Section 1.3

Indications For Use

Page 13 of 24

{26}------------------------------------------------

Q Series & i7, i8, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: V6C10L, Volume Probe

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N	N	N	N	N	N	3.4.5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	N	5
	Other (Ob/GYN)	N	N	N	N	N	N	N	N	5
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

E = added under this appendix N = new indication; P = previously cleared by FDA; Note : I. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD.B/Power/PWD

2.Small Organ; Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging 5. Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{27}------------------------------------------------

Q Series & 17, i8, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems System: Transducer: D5C20L, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	FetalAbdominal	P	P	P		P	P	P	P	4.5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	P	4.5
	Small Organ(1) (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P		P	P	P	P	5
Peripheral Vessel	Peripheral vessel

E = added under this appendix P = previously cleared by FDA: N = new indication;

Note : 1. Combined modes are B/M, B+PWD. B/Color M. B/PWD or CWD.B/ColorPWD or CWD.B/Power/PWD 2.Small Organ: Breast. testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Over-The-Counter Use × AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{28}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D5C20L-A, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N	N	N	N	N	N	4.5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	N	4.5
	Small Organ(1) (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	N	5
Peripheral Vessel	Peripheral vessel

F: = added under this appendix N = new indication: P = previously cleared by FDA:

Note : 1. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/41) Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K101236. KT20801

AND/OR Over-The-Counter Use Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEIEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{29}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D3C20L, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
--------------------------------------------------------------------------------------------------	--	--	--

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N	N	N	N	N	N	4,5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ" (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	N	5
	Other (Ob/GYN)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	N	5
	Cardiac Pediatric	N	N	N	N	N	N	N	N	5
Peripheral Vessel	Peripheral vessel

E = added under this appendix P = previously cleared by FDA; N = new indication;

Note : 1. Combined modes are B/M, B+PWD, B/Color M, B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Flastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{30}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D6C15L, Micro Convex Array

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track I Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	P	P	P	P	P	P	P	P	4.5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	N	5
	Small Organ1 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note : 1. Combined modes are B/M, B+PWD, B/Color M. B/PWD or CWD, B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

Elastography imaging
Includes imaging of guidance of biopsy

× AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{31}------------------------------------------------

Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems System: D6C15L-A, Micro Convex Array Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal	N	N	N	N	N	N	N	N	4.5
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	N	5
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note : I. Combined modes arc B/M, B+PWD. B/Color M. B/PWD or CWD, B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K101236. K120801

Over-The-Counter Use × AND/OR Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{32}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems D3P64L, Phased Array Transducer:

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	P	5
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

E = added under this appendix N = new indication; P = previously cleared by FDA;

Note : I. Combined modes are B/M, B+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD 2.Small Organ: Breast. testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

× AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{33}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D6P64L, Phased Array

Clinical Application	Mode of Operation

General(Track 1 Only)	Specific(Tracks 1 & 3)	ાં કે	M	I>W	CW	ColorDoppler Doppler Doppler Doppler	Power	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ" (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P	P	P	S
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

P = previously cleared by FDA; E = added under this appendix N = new indication; Note : I. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD

2.Small Organ: Breast, testes. thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{34}------------------------------------------------

System: Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems Transducer: D2D16L, Pencil Array

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(1) (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
	Other (Ob/GYN)
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendix Note : 1. Combined modes are B/M, 8+PWD. B/Color M. B/PWD or CWD. B/Color/PWD or CWD.B/Power/PWD

2.Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236

Prescription Use × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{35}------------------------------------------------

Q Series & 17, i8, i9 Diagnostic Ultrasound Systems

Chison Medical Imaging Co., Ltd.

Q6/Q8/Q9/Q10,i7/i8/i9 Diagnostic Ultrasound Systems System: Transducer: V4C40L, Volume probe

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P	P	P	P	P	P	3.
Other	Abdominal	P	P	P	P	P	P	P	P	3,4
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	P	P	P	P	P	P	P	P
	Other (Ob/GYN)	P	P	P	P	P	P	P	P
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

previously cleared by FDA; N = new indication; Note : 1. Combined modes are B/M, B/Color M. B/PWD or CWD, B/Color/PWD or CWD,B/Power/PWD

2.Smail Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

× AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{36}------------------------------------------------

Q6/Q8/Q9/Q10, i7/i8/i9 Diagnostic Ultrasound Systems System: Transducer: V4C40L-C, Volume Probe

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N	N	N	3.
	Abdominal	N	N	N	N	N	N	N	N	3.4
	Intra-operative(Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	N
	Other (Ob/GYN)	N	N	N	N	N	N	N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
Peripheral Vessel	Peripheral vessel

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

P = previously cleared by FDA; E = added under this appendix N = new indication; Note : I. Combined modes are B/M. B+PWD. B/Color M. B/PWD or CWD. B/ColorPWD or CWD.B/Power/PWD

Small Organ: Breast, testes, thyroid

3.3D/4D Imaging Mode

4.Elastography imaging

Includes imaging of guidance of biopsy

Predicate transducer (K number): K 101236. K 120801

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.