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

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.

Predicate Devices

K153085

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention any AI or ML capabilities. There is no mention of AI, DNN, or ML, nor are there descriptions of training or test sets which are typical for AI/ML device submissions.

Therapeutic

No.
The device is described as a "Diagnostic Ultrasound System" intended for "clinical diagnostic imaging applications" and does not mention any therapeutic capabilities or interventions.

Diagnostic

Yes

The 'Device Description' explicitly states: "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." It further describes itself as a "color diagnostic ultrasound system." The 'Intended Use / Indications for Use' section lists various clinical evaluations for which the device is intended, all of which fall under diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color doppler ultrasound imaging system" consisting of a "mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes." This indicates the device includes significant 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 the device is for "evaluation" and "clinical diagnostic imaging applications" using ultrasound. 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 modes (B-Mode, M-Mode, Doppler, etc.). This is consistent with an imaging device, not a device that analyzes samples taken from the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

IVD devices are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system operates by sending and receiving sound waves to create images of internal anatomy.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Cardiac (adult, pediatric), Musculoskeletal (Conventional, Superficial), Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Urology.

Indicated Patient Age Range

Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic, Adult, Pediatric.

Intended User / Care Setting

qualified physician

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)

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.

Clinical Test:
No clinical testing was required.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153085

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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.

1

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

2

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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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)

6

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

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	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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)

8

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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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)

10

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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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

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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes	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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SonoBook Series Diagnostic Ultrasound System System: Transducer: CW2-V

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	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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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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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	PW
Doppler	CW
Doppler	Color
Doppler	Power
Doppler	Combined
Modes
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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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, China
No.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:

32

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 Device
Q Series Diagnostic
Ultrasound System
K150861 | Submission Device
SonoBook Series
Diagnostic Ultrasound
System - 510(k) TBD | Remark |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Indications for Use | Fetal
Abdominal
Pediatric
Small Organ (breast, thyroid, testes)
Neonatal Cephalic, Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal( | Fetal
Abdominal
Pediatric
Small Organ (breast, thyroid, testes)
Neonatal Cephalic, Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal( Conventional, | Same |
| | Predicate Device | Submission Device | |
| Product Name
(K number) | Q Series Diagnostic
Ultrasound System
K150861 | SonoBook Series
Diagnostic Ultrasound
System - 510(k) TBD | Remark |
| Design | Conventional, Superficial)
Cardiac(adult ,pediatric)
Peripheral Vascular
Urology
Transesophageal | Superficial)
Cardiac(adult ,pediatric)
Peripheral Vascular
Urology
Transesophageal | |
| | Based on an embedded
WINDOWS
operating system.
Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting Linear, Curve,
Phase array and Volume
probes.
Cine play back capability
Image file archive | Based on an embedded
WINDOWS operating system.
Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing.
Supporting Linear, Curve, Phase
array and Volume probes.
Cine play back capability
Image file archive | Same |
| Operation Controls | TGC 8 slider
Depth Range: 0 to 30 cm
256 shades of gray | TGC 8 slider
Depth Range: 0 to 30 cm
256 shades of gray | Same |
| | B Dynamic range control: 30-
180 dB, 5/step | B Dynamic range control: 60-
165 dB, 7/step | SE
Analysis 1 |
| | Gain:0-255
Focal Number: adjustable
Focus position: adjustable
B steer: available on linear
transducers | Gain:0-255
Focal Number: adjustable
Focus position: adjustable
B steer: available on linear
transducers | Same |
| | B Persistence: 7 steps
ROI size/position: adjustable | B Persistence: 7 steps
ROI size/position: adjustable | Same |
| | Color Wall Filter settings:8
steps | Color Wall Filter settings:4 steps | SE
Analysis 1 |
| | Color Baseline: 16 steps | Color Baseline: 7 steps | SE
Analysis 1 |
| | Color Maps: 21 maps | Color Maps: 11 maps | SE
Analysis 1 |
| | Color Invert: on/off | Color Invert: on/off | Same |
| | PW sweeping speed: 6 steps | PW sweeping speed: 3 steps | SE
Analysis 1 |
| | PW Wall Filter: 7 steps | PW Wall Filter: 4 steps | SE
Analysis 1 |
| | PW sample volume: 0.5-
30mm (PW only), 13 steps | PW sample volume: 1-8mm (PW
only), 8 steps | SE
Analysis 1 |
| | PW angle correction:-
8989degrees,1/step | PW angle correction :-
8080degrees,5/step | SE
Analysis 1 |
| | Baseline: 8steps | Baseline: 7steps | SE
Analysis 1 |
| | Cine control: step, play
backward, play continuously | Cine control: step, play
backward, play continuously | Same |
| | Predicate Device | Submission Device | |
| Product Name
(K number) | Q Series Diagnostic
Ultrasound System
K150861 | SonoBook Series
Diagnostic Ultrasound
System - 510(k) TBD | Remark |
| | Doppler Auto Trace | Doppler Auto Trace | Same |
| | Freeze control: Toggling
freeze key | Freeze control: Toggling freeze
key | Same |
| Safety Standards
Compliance | IEC60601-1
IEC60601-1-2
IEC60601-2-37
ISO 10993-1
ISO 10993-5
ISO 10993-10
AIUM/ NEMA UD2
AIUM/ NEMA UD3 | IEC60601-1
IEC60601-1-2
IEC60601-2-37
ISO 10993-1
ISO 10993-5
ISO 10993-10
AIUM/ NEMA UD2
AIUM/ NEMA UD3 | Same |
| Operation Mode | B, THI,B/M, M, Color M, Free
Steering M, CFM,
PW,PDI,DPD,CW, 3D/ 4D,
TDI, Elastography, Curved
Panoramic, Trapezoidal
image, Compound Imaging | B, FHI,B/M, M, Color M, Free
Steering M, CFM, PW, PDI,
DPD, CW, 3D/4D, Elastography,
TDI, Curved
Panoramic,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,CW
B/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; Exam
date; Exam time; Acoustic
Power; Mechanical index;
Tissue thermal indes; ID, Last
name, First Name, Middle
initial, Gender, Age; Probe
model; ECG ico; Operator;
TGC Curve; Focus position;
Thumbnail; Imaging
parameters; Dynamic
Trackball indices | Logo; Hospital Name; Exam
date; Exam time; Acoustic
Power; Mechanical index;
Tissue thermal index: ID, Last
name, First Name, Middle initial,
Gender, Age; Probe model;
ECG ico; Operator; TGC Curve;
Focus position; Thumbnail;
Imaging parameters; Dynamic
Trackball indices | Same |
| Display Monitor | 15"high-resolution color LCD
monitor | 15" high-resolution color LCD
monitor | Same |
| | Predicate Device | Submission Device | |
| Product Name
(K number) | Q Series Diagnostic
Ultrasound System
K150861 | SonoBook Series
Diagnostic Ultrasound
System - 510(k) TBD | Remark |
| Measurements | 2D mode: Depth, Distance,
Area: Ellipse, Trace, Spline,
Cross, Trace Length, Double
Distance, Parallel, Volume:
Distance, Ellipse, Ellipse +
Distance, Length Ratio, Area
Ratio, IMT, B Histogram, B
Profile, Volume Flow, Color
Velocity;
M mode: Distance, Time,
Slope, Heart Rate, Velocity;
Doppler mode: D Velocity,
Time, Heart Rate,
Acceleration, D Trace, PS/ED,
Volume Flow; | 2D mode: Depth, Distance,
Area: Ellipse, Trace, Spline,
Trace Length, 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; | SE
Analysis2 |
| Transducer Types &
Connectors | Convex Array, Phased Array,
Linear Array, Volume probe
2ports | Convex Array, Phased Array,
Linear Array, Volume probe
1ports | SE
Analysis3 |
| Acoustic Output | Derated ISPTA: 720mW/cm²
maximum.
TIS/TIB/TIC: 6.0 maximum,
MI: 1.9 maximum,
Derated ISPPA: 190
W/cm²maximum | Derated ISPTA: 720mW/cm²
maximum.
TIS/TIB/TIC: 6.0 maximum,
MI: 1.9 maximum,
Derated ISPPA: 190
W/cm²maximum | Same |
| Power Supply | Voltage: 100-240V~
Frequenzy:50-60Hz
Power Consumption: 300VA
Max | Voltage: 100-240V~
Frequenzy:50-60Hz
Power Consumption: 300VA
Max | Same |

33

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.