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

• K Number: K140364
• Device Name: CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
• Manufacturer: CHISON MEDICAL IMAGING CO., LTD.
• Date Cleared: 2014-06-02 ( 110 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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 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.

Predicate Devices

K101236, K120801

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention AI, ML, or related concepts.

Therapeutic

No.

The device is described as a "general-purpose ultrasonic imaging instrument" and a "diagnostic ultrasound system," intended for "clinical diagnostic imaging applications" and "evaluation" of various anatomical sites, not for treatment.

Diagnostic

Yes

The device description explicitly states, "This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system." Its basic function is to acquire ultrasound echo data and display images in various modes for clinical diagnostic imaging applications.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color doppler ultrasound imaging system" and can be configured as a "portable model" or a "roll-around model on wheels," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is a general-purpose ultrasonic imaging instrument for use by a qualified physician for the evaluation of various anatomical sites. This involves imaging the internal structures of the body.
• Device Description: The description details an ultrasound system that acquires and displays ultrasound echo data in various imaging modes. This is a diagnostic imaging device, not a device that performs tests on samples taken from the body (like blood, urine, or tissue).
• Lack of IVD Characteristics: There is no mention of the device being used to test samples, analyze biomarkers, or provide information about a patient's health status based on in vitro analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system is used for non-invasive imaging of the body itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

90-IYN, 90-IYO, 90-ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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.

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

qualified physician
Hospitals, clinics usage

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

No clinical testing was required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101236, K120801

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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

1

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

2

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

3

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510(K) Submission

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| Product Name
(K number) | Predicate Device | CHISON
iVis60EXPERT,Q6/Q8,i7
K120801 | Submission Device
Q Series & i7,i8,i9
TBD | Remark |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Indications
for Use | Voluson E8/E8Expert
K101236 | Fetal (Obstetrics);
Abdomen;
Small Organ (Thyroid, testes
and 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 and
breast);
Cardiac (adult and pediatric);
Musculo-skeletal (Conventional and
Superficial);
Peripheral Vascular,
Transvaginal,
OB/Gyn and Urology. | Same |
| | Fetal (Obstetrics);
Abdominal (including GYN, pelvic
and infertility monitoring/follicle
development); Pediatric;
Small Organ (breast, testes, thyroid
etc); Neonatal and Adult Cephalic;
Cardiac (adult and pediatric);
Musculo-skeletal Conventional and
Superficial;
Peripheral Vascular;
Transrectal;
Transvaginal and Intraoperative
(abdominal, PV and neurological). | Autocorrelation for color
processing, and FFT for
pulse and CW Doppler
processing. Supporting Linear, Curve
linear, Phase array and
Pencil probes. Cine play back capability Image file archive Software upgrade with
USB flash drive. Digital multi-beam
forming | Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing. Supporting Linear, Curve
linear, Phase array and
Pencil probes. Cine play back capability Image file archive Software upgrade with USB
flash drive. Digital multi-beam forming | Same |
| Design | Autocorrelation for color
processing and FFT for
pulse and CW Doppler
processing. Supporting Linear, Curve
linear, Phase array and
Pencil probes. Cine play back capability Image file archive Software upgrade with USB
flash drive. Digital multi-beam forming | | | |
| Product Name
(K number) | Predicate Device
Voluson E8/E8Expert
K101236 | CHISON
iVis60EXPERT,Q6/Q8,i7
K120801 | Submission Device
Q Series & i7,i8,i9
TBD | Remark |
| Operating
Controls | TGC 8 slider | TGC 8 slider | TGC 8 slider | Same |
| | Depth Range: 0 to 30 cm | Depth Range:030cm | Depth Range:030cm | 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
key to control size and position | Color ROI setting: trackball and set key to control size and
position | Color ROI setting: trackball and set key to control size and
position | Same |
| Product Name
(K number) | Predicate Device
Voluson E8/E8Expert
K101236 | CHISON
iVis60EXPERT,Q6/Q8,i7
K120801 | Submission Device
Q Series & i7,i8,i9
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
Compliance | IEC60601-1 Medical electrical
equipment - Part 1: General
requirements for safety | IEC60601-1 Medical electrical
equipment - Part 1: General
requirements for safety | IEC60601-1 Medical electrical
equipment - Part 1: General
requirements for safety | |
| | IEC60601-1-2 Medical electrical
equipment - Part 1-2: General
requirements for safety - Collateral
standard: Electromagnetic
compatibility - Requirements and tests | IEC60601-1-2 Medical electrical
equipment - Part 1-2: General
requirements for safety -
Collateral standard:
Electromagnetic compatibility -
Requirements and tests | IEC60601-1-2 Medical electrical
equipment - Part 1-2: General
requirements for safety -
Collateral standard:
Electromagnetic compatibility -
Requirements and tests | |
| | IEC60601-2-37 Medical electrical
equipment - Part 2-37: Particular
requirements for the safety of
ultrasonic medical diagnostic and
monitoring equipment | IEC60601-2-37 Medical
electrical equipment - Part 2-37:
Particular requirements for the
safety of ultrasonic medical
diagnostic and monitoring
equipment | IEC60601-2-37 Medical
electrical equipment - Part 2-37:
Particular requirements for the
safety of ultrasonic medical
diagnostic and monitoring
equipment | Same |
| | ISO 10993-5 Biological evaluation of
medical devices - Part 5: Tests for in
vitro cytotoxicity | ISO 10993-5 Biological | ISO 10993-5 Biological
evaluation of medical devices -
Part 5: Tests for in vitro
cytotoxicity | |
| | ISO 10993-10 Biological evaluation
medical devices - Part 10: Tests for
imitation and delayed-type
hypersensitivity | | ISO 10993-10 Biological
evaluation of medical devices -
Part 10: Tests for imitation and
delayed-type hypersensitivity | |

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510(K) Submission

Chison Medical Imaging Co.. Ltd.

SUBMISSION

Emission

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

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510(K) Submission

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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.

11

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 [phone] or [phone] 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 [phone] or [phone] 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

13

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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

4. Elastography imaging

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

1

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

2. Small Organ, Breast, Testis
3. B/W/US Imaging Mode

3.3D/40 Imaging Mode 4.Flastography imaging

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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)

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(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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. Includes imaging of guidance of biopsy

:

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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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)

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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Other
Ophthalmic	Ophthalmic
Fetal Imaging &
Other	Fetal
Abdominal	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. Includes imaging of guidance of biopsy

Predicate transducer (K number): K101236. KT20801

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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

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)

(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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

4. Elastography imaging

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	Color
Doppler Doppler Doppler Doppler	Power	Combined
Modes	Harmonic
Imaging	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

5. 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	Combined
Modes	Harmonic
Imaging	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

5. 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)

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(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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

5. 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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	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

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. 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)