SonoBook Series Diagnostic Ultrasound System

• K Number: K170374
• Device Name: SonoBook Series Diagnostic Ultrasound System
• Manufacturer: CHISON Medical Imaging Co., Ltd.
• Date Cleared: 2017-06-06 ( 119 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K153085
• Predicate For: K092819 , K173962 , K180974

Intended Use

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

Device Description

The SonoBook Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) the image Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

AI/ML Overview

This document describes the SonoBook Series Diagnostic Ultrasound System and compares it to a predicate device (Q Series Diagnostic Ultrasound System K150851) to demonstrate substantial equivalence for FDA 510(k) clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense, as this is a submission for a general diagnostic ultrasound system rather than an AI-enabled diagnostic algorithm. Instead, it demonstrates compliance with relevant medical device safety and performance standards and compares its features to a predicate device.

The "acceptance criteria" here implicitly refer to meeting established safety standards and having comparable functionality to the predicate device. "Reported device performance" is indicated by the system's features and compliance.

Acceptance Criteria (Implicit)	Reported Device Performance (SonoBook Series)
Compliance with Safety Standards (Electrical, Mechanical, Thermal, EMC)	IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-37: 2007 (Passed all laboratory tests for safety)
Compliance with Acoustic Output Standards	NEMA UD 2-2004, NEMA UD3: 2004 (Derated ISPTA: 720mW/cm² max, TIS/TIB/TIC: 6.0 max, MI: 1.9 max, Derated ISPPA: 190 W/cm² max - Same as predicate device)
Biocompatibility	ISO 10993-1:2009 (Compliant)
Indications for Use	Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology (Consistent with predicate device)
Design (Software, Probes, Playback, Archiving)	Based on embedded WINDOWS OS, Autocorrelation for color processing, FFT for pulse/CW Doppler, supports Linear, Curve, Phase array and Volume probes, Cine playback, Image file archive (Consistent with predicate device)
Operation Controls (TGC, Depth Range, B Dynamic Range, Gain, Focus, B Steer, B Persistence, ROI, Color/PW Filters, Color Baseline, Color Maps, PW Sample Volume, PW Angle Correction, Baseline, Cine Control, Doppler Auto Trace, Freeze Control)	Largely similar to predicate device. Some differences in value ranges or steps (e.g., B Dynamic range: 60-165 dB (vs 30-180 dB of predicate), Color Wall Filter: 4 steps (vs 8), Color Baseline: 7 steps (vs 16), Color Maps: 11 maps (vs 21), PW sweeping speed: 3 steps (vs 6), PW Wall Filter: 4 steps (vs 7), PW sample volume: 1-8mm (vs 0.5-30mm), PW angle correction: -8080 degrees (vs -8989 degrees), Baseline: 7 steps (vs 8). These differences are deemed "Substantially Equivalent" as they comply with standards and meet clinical requirements without raising new risks.
Display Modes	B, 2B, 4B, B/M, M, TDI, 3D/4D, CW, B/BC, B+Color M, B+PW/CW, B+CFM, B+PDI/DPD, B+CFM+PW/CW, B+PDI/DPD+PW (Consistent with predicate device)
Display Annotations	Logo, Hospital Name, Exam date/time, Acoustic Power, Mechanical Index, Tissue thermal index, Patient info (ID, name, gender, age), Probe model, ECG icon, Operator, TGC Curve, Focus position, Thumbnail, Imaging parameters, Dynamic Trackball indices (Consistent with predicate device)
Display Monitor	15" high-resolution color LCD monitor (Consistent with predicate device)
Measurements	2D mode: Depth, Distance, Area (Ellipse, Trace, Spline, Trace Length), Volume (Distance, Ellipse, Ellipse + Distance), Distance Ratio, Area Ratio, IMT, Volume Flow. M mode: Distance, Time, Heart Rate, Velocity. Doppler mode: D Velocity, Time, Heart Rate, Acceleration, D Trace, S/D, Volume Flow. (Some differences in specific items compared to predicate, but the basic clinical items are included and meet clinical use without new risk.)
Transducer Types & Connectors	Convex Array, Phased Array, Linear Array, Volume probe, 1 port (Predicate had 2 ports, but deemed SE as both comply with IEC60601-1)
Power Supply	Voltage: 100-240V~, Frequency: 50-60Hz, Power Consumption: 300VA Max (Consistent with predicate device)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states "No clinical testing was required." (Section 7). The submission relies on non-clinical tests (lab tests) and comparison to a legally marketed predicate device. Therefore, there is no test set in the sense of patient data for evaluating diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as no clinical testing was performed and no specific "ground truth" for a test set of patient data was established for diagnostic performance. The ground truth for functional and safety validation would be the compliance with recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a submission for a general diagnostic ultrasound system, not an AI-enabled diagnostic algorithm, and no clinical effectiveness studies of this nature were performed or required.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this submission is implicitly defined by the adherence to recognized international and national consensus standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37), acoustic output (NEMA UD 2-2004, NEMA UD3:2004), and biocompatibility (ISO 10993-1). The comparison is primarily against the performance and features of the predicate device (Q Series Diagnostic Ultrasound System K150851).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device that requires a training set of data.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 6, 2017

Chison Medical Imaging Co., Ltd. % Bob Leiker Leiker Regulatory & Quality 4157 North Del Rey Ave CLOVIS, CA 93619

Re: K170374

Trade/Device Name: SonoBook Series 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 27, 2017 Received: May 3, 2017

Dear Mr. Bob 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.

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.

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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" (21 CFR 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 yours.

Michael D'Hara
For

Robert Ochs. Ph.D. 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

510(k) Number (if known)

K170374

Device Name

SonoBook Series Diagnostic Ultrasound System

Indications for Use (Describe)

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

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)

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Diagnostic Ultrasound Indications For Use

System: SonoBook Series Diagnostic Ultrasound System

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	3,5,6
	Abdominal	N	N	N		N	N	N	3,4,5,6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ1 (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic	N	N	N	N	N	N	N	6,7
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal	N	N	N		N	N	N	4,5,6
	Trans-vaginal	N	N	N		N	N	N	3,4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric	N	N	N	N	N	N	N	5,6,7
	Transesophageal	N	N	N	N	N	N	N	6,7
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

N = new indication; P = previously cleared by FDA;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

X 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 In Vitro Diagnostics and Radiological Health (OIR)

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System: SonoBook Series Diagnostic Ultrasound System Transducer: C3-V

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N	N	5,6
Other	Abdominal	N	N	N	N	N	N	N	4,5,6
	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)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
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, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3.3D/4D

4. Elastography

5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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SonoBook Series Diagnostic Ultrasound System System: Transducer: C3M-V

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N	N	5,6
	Abdominal	N	N	N	N	N	N	N	4,5,6
	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)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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SonoBook Series Diagnostic Ultrasound System System: Transducer: C3T-V

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	5,6
Other	Abdominal	N	N	N		N	N	N	4,5,6
	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)	N	N	N		N	N	N	4,5,6
	Cardiac	Cardiac Adult
		Cardiac Pediatric
Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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System: SonoBook Series Diagnostic Ultrasound System Transducer: L7-V

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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SonoBook Series Diagnostic Ultrasound System System: Transducer: L7SVA-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

{9}------------------------------------------------

SonoBook Series Diagnostic Ultrasound System System: Transducer: L8Mb-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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System: SonoBook Series Diagnostic Ultrasound System Transducer: L12b-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

{11}------------------------------------------------

System: SonoBook Series Diagnostic Ultrasound System Transducer: L8M-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5, 6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: L12-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

{13}------------------------------------------------

SonoBook Series Diagnostic Ultrasound System System: Transducer: L12M-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: L10i-V

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

Clinical Application		Mode of Operation							Other
General	Specific	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	Combined Modes
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: R7-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	N	N	N		N	N	N	4,5,6
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

Prescription Use メ 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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: L8M5-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ [1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: L18-V

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

Clinical Application		Mode of Operation
General	Specific	B	M	PW	CW	Color	Power	Combined	Other
(Track 1 Only)	(Tracks 1 & 3)			Doppler	Doppler	Doppler	Doppler	Modes
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal
Other	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	4,5,6
	Small Organ[1] (Specify)	N	N	N		N	N	N	4,5,6
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	4,5,6
	Musculo-skeletal(Superficial)	N	N	N		N	N	N	4,5,6
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel	N	N	N		N	N	N	5,6

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

System: SonoBook Series Diagnostic Ultrasound System Transducer: E6-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ1 (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

Prescription Use メ 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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: E7W-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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	N	N	N	N	N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
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/CFM , B/PD, B/DPD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use メ AND/OR Over-The-Counter 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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: E7MW-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PW Doppler	CW Doppler	Color Doppler	Power Doppler	CombinedModes
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	N	N	N		N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
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/CFM , B/PD, B/DPD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use メ AND/OR Over-The-Counter 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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: R7B8-V

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	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	N	N	N		N	N	N	4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N		N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
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/CFM , B/PD, B/DPD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use メ AND/OR Over-The-Counter 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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: V6E-V

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	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	N	N	N	N	N	N	N	3,4,5,6
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)	N	N	N	N	N	N	N	5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
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/CFM , B/PD, B/DPD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

Prescription Use メ AND/OR Over-The-Counter 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 In Vitro Diagnostics and Radiological Health (OIR)

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

System: SonoBook Series Diagnostic Ultrasound System Transducer: MC3-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	4,5,6
	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)	N	N	N		N	N	N	4,5,6
Cardiac	Cardiac Adult	N	N	N		N	N	N	5,6
	Cardiac Pediatric	N	N	N		N	N	N	5,6
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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 In Vitro Diagnostics and Radiological Health (OIR)

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: MC6-V

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N	N	N	N	N	5,6
	Abdominal	N	N	N	N	N	N	N	4,5,6
	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)	N	N	N	N	N	N	N	4,5,6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

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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SonoBook Series Diagnostic Ultrasound System System: Transducer: P3T-V

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

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

System: SonoBook Series Diagnostic Ultrasound System Transducer: P2-V

Clinical Application		Mode of Operation								Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N	N	N	N	N	6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	6,7
	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	N	N	N	N	N	N	5,6,7
	Cardiac Pediatric
	Transesophageal
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, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3.3D/4D

• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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

System: SonoBook Series Diagnostic Ultrasound System Transducer: P5-V

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	Other
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal	N	N	N		N	N	N	6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ[1] (Specify)
	Neonatal Cephalic	N	N	N	N	N	N	N	6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N	N	N	N	N	5,6,7
	Transesophageal
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/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: CW2-V

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

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D
• 4. Elastography
• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging
• 7. TDI

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: VC4-V

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	N	N	N		N	N	N	3,6
	Abdominal	N	N	N		N	N	N	3,4,6
	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)	N	N	N		N	N	N	6
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal
Peripheral Vessel	Peripheral vessel

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

P = previously cleared by FDA; N = new indication;

E = added under this appendix

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

• 3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)
• 6. Fusion Harmonic Imaging

7. TDI

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

SonoBook Series Diagnostic Ultrasound System System: Transducer: T5-V

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

Clinical Application		Mode of Operation							Other
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWDoppler	CWDoppler	ColorDoppler	PowerDoppler	CombinedModes
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
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Other (Urology)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Transesophageal	N	N	N	N	N	N	N	6,7
Peripheral Vessel	Peripheral vessel

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

Note : 1. Combined modes are B/M, B/CFM , B/PD, B/PW or CW, B/Color M, B/BC,B/CFM/PW or CW,B/PD or DPD/PW or CW

2. Small Organ: thyroid, testes, breast

3. 3D/4D

4. Elastography

• 5. Includes guidance of biopsy (2D)

6. Fusion Harmonic Imaging

7. TDI

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

510(k) Summary

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

1. Submitter:

Submitter:	Chison Medical Imaging Co., Ltd.
Address:	No.228, ChangJiang East Road,Block 51 and 53,Phase 5 Industrial Park, ShuoFang, New District,Wuxi 214142, ChinaNo.9 Xin Hui Huan Road, New District ,WuXi P.R.China
Contact:	Ms. Ruoli Mo
Tel:	[phone], 85310593
Fax:	[phone]
Date Prepared:	December 29, 2016

2. Device :

SonoBook Series Diagnostic Ultrasound System Trade Name:

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

3. Predicate Device(s):

Q Series Diagnostic Ultrasound System 510(k) Number: K153085

4. Device Description:

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

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

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

5. Indications for Use:

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

6. Summary of Non-Clinical Tests:

The SonoBook Series Diagnostic Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

Laboratory tests were conducted to verify that the SonoBook Series Diagnostic Ultrasound System met all design specifications and the SonoBook Series Diagnostic Ultrasound System conformed to applicable medical device standards.

The SonoBook Series Diagnostic Ultrasound System has been designed and manufactured to meet the following standards:

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

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 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

7. Clinical Test:

No clinical testing was required.

8. Comparison to Predicate Device:

Table 1 Substantial Equivalence Comparison

Product Name(K number)	Predicate DeviceQ Series DiagnosticUltrasound SystemK150861	Submission DeviceSonoBook SeriesDiagnostic UltrasoundSystem - 510(k) TBD	Remark
Indications for Use	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, Adult CephalicTrans-rectalTrans-vaginalMusculo-skeletal(	FetalAbdominalPediatricSmall Organ (breast, thyroid, testes)Neonatal Cephalic, Adult CephalicTrans-rectalTrans-vaginalMusculo-skeletal( Conventional,	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	SonoBook SeriesDiagnostic UltrasoundSystem - 510(k) TBD	Remark
Design	Conventional, Superficial)Cardiac(adult ,pediatric)Peripheral VascularUrologyTransesophageal	Superficial)Cardiac(adult ,pediatric)Peripheral VascularUrologyTransesophageal
	Based on an embeddedWINDOWSoperating system.Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve,Phase array and Volumeprobes.Cine play back capabilityImage file archive	Based on an embeddedWINDOWS operating system.Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing.Supporting Linear, Curve, Phasearray and Volume probes.Cine play back capabilityImage file archive	Same
Operation Controls	TGC 8 sliderDepth Range: 0 to 30 cm256 shades of gray	TGC 8 sliderDepth Range: 0 to 30 cm256 shades of gray	Same
	B Dynamic range control: 30-180 dB, 5/step	B Dynamic range control: 60-165 dB, 7/step	SEAnalysis 1
	Gain:0-255Focal Number: adjustableFocus position: adjustableB steer: available on lineartransducers	Gain:0-255Focal Number: adjustableFocus position: adjustableB steer: available on lineartransducers	Same
	B Persistence: 7 stepsROI size/position: adjustable	B Persistence: 7 stepsROI size/position: adjustable	Same
	Color Wall Filter settings:8steps	Color Wall Filter settings:4 steps	SEAnalysis 1
	Color Baseline: 16 steps	Color Baseline: 7 steps	SEAnalysis 1
	Color Maps: 21 maps	Color Maps: 11 maps	SEAnalysis 1
	Color Invert: on/off	Color Invert: on/off	Same
	PW sweeping speed: 6 steps	PW sweeping speed: 3 steps	SEAnalysis 1
	PW Wall Filter: 7 steps	PW Wall Filter: 4 steps	SEAnalysis 1
	PW sample volume: 0.5-30mm (PW only), 13 steps	PW sample volume: 1-8mm (PWonly), 8 steps	SEAnalysis 1
	PW angle correction:-89~89degrees,1/step	PW angle correction :-80~80degrees,5/step	SEAnalysis 1
	Baseline: 8steps	Baseline: 7steps	SEAnalysis 1
	Cine control: step, playbackward, play continuously	Cine control: step, playbackward, play continuously	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	SonoBook SeriesDiagnostic UltrasoundSystem - 510(k) TBD	Remark
	Doppler Auto Trace	Doppler Auto Trace	Same
	Freeze control: Togglingfreeze key	Freeze control: Toggling freezekey	Same
Safety StandardsCompliance	IEC60601-1IEC60601-1-2IEC60601-2-37ISO 10993-1ISO 10993-5ISO 10993-10AIUM/ NEMA UD2AIUM/ NEMA UD3	IEC60601-1IEC60601-1-2IEC60601-2-37ISO 10993-1ISO 10993-5ISO 10993-10AIUM/ NEMA UD2AIUM/ NEMA UD3	Same
Operation Mode	B, THI,B/M, M, Color M, FreeSteering M, CFM,PW,PDI,DPD,CW, 3D/ 4D,TDI, Elastography, CurvedPanoramic, Trapezoidalimage, Compound Imaging	B, FHI,B/M, M, Color M, FreeSteering M, CFM, PW, PDI,DPD, CW, 3D/4D, Elastography,TDI, CurvedPanoramic,Trapezoidal image,Compound Imaging	Same
Display Modes	B, 2B,4B, B/M ,M,TDI,3D/4D,B/BC,B/M, B+Color M,B+PW, B+CFM, B+PDI/DPD,B+CFM+PW/CW,B+PD/DPD+PW/CW	B, 2B,4B, B/M ,M,TDI,3D/4D,CWB/BC,B/M, B+Color M,B+PW/CW,B+CFM, B+PDI/DPD,B+CFM+PW/CW,B+PDI/DPD+PW	Same
Display Annotations	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index;Tissue thermal indes; ID, Lastname, First Name, Middleinitial, Gender, Age; Probemodel; ECG ico; Operator;TGC Curve; Focus position;Thumbnail; Imagingparameters; DynamicTrackball indices	Logo; Hospital Name; Examdate; Exam time; AcousticPower; Mechanical index;Tissue thermal index: ID, Lastname, First Name, Middle initial,Gender, Age; Probe model;ECG ico; Operator; TGC Curve;Focus position; Thumbnail;Imaging parameters; DynamicTrackball indices	Same
Display Monitor	15"high-resolution color LCDmonitor	15" high-resolution color LCDmonitor	Same
	Predicate Device	Submission Device
Product Name(K number)	Q Series DiagnosticUltrasound SystemK150861	SonoBook SeriesDiagnostic UltrasoundSystem - 510(k) TBD	Remark
Measurements	2D mode: Depth, Distance,Area: Ellipse, Trace, Spline,Cross, Trace Length, DoubleDistance, Parallel, Volume:Distance, Ellipse, Ellipse +Distance, Length Ratio, AreaRatio, IMT, B Histogram, BProfile, Volume Flow, ColorVelocity;M mode: Distance, Time,Slope, Heart Rate, Velocity;Doppler mode: D Velocity,Time, Heart Rate,Acceleration, D Trace, PS/ED,Volume Flow;	2D mode: Depth, Distance,Area: Ellipse, Trace, Spline,Trace Length, Volume:Distance, Ellipse, Ellipse +Distance, Distance Ratio, AreaRatio, IMT, Volume Flow,M mode: Distance, Time, HeartRate, Velocity;Doppler mode: D Velocity, Time,Heart Rate, Acceleration, DTrace, S/D, Volume Flow;	SEAnalysis2
Transducer Types &Connectors	Convex Array, Phased Array,Linear Array, Volume probe2ports	Convex Array, Phased Array,Linear Array, Volume probe1ports	SEAnalysis3
Acoustic Output	Derated ISPTA: 720mW/cm²maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm²maximum	Derated ISPTA: 720mW/cm²maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm²maximum	Same
Power Supply	Voltage: 100-240V~Frequenzy:50-60HzPower Consumption: 300VAMax	Voltage: 100-240V~Frequenzy:50-60HzPower Consumption: 300VAMax	Same

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

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

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

SE Analysis1:

Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range or setting. But both of them comply with the requirements of IEC60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

SE Analysis2:

Compared with the predicate device, the subject device has some differences in Measurement Items. But all of them for the subject device include the clinical basic items, and fall within these for the predicate device; all of them meet the clinical use and no new risk is raised.

SE Analvsis3:

The probe connectors of the proposed device and the predicate device are 1 ports and 2 ports, but both them comply with the requirements of IEC60601-1. Therefore they can be considered Substantially Equivalent in safety, and no new risk is raised, so the SE is not affected. Therefore, probe connectors can be considered Substantially Equivalent in safety.

9. Substantially Equivalent Conclusion:

In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Imaging Co., Ltd. concludes that the SonoBook Series Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.

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.