SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K093714
• Device Name: SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: MEDISON CO., LTD.
• Date Cleared: 2009-12-10 ( 8 days)
• Product Code: ITX IYN IYO
• Regulation Number: 892.1570

Intended Use

The SQNOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

Device Description

The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The SONOACE X8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

Predicate Devices

K063580, K092159

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system with various imaging modes and measurement tools. There is no mention of AI, ML, deep learning, or any related concepts in the provided text. The description focuses on the hardware and basic software functionalities for image acquisition and display.

Therapeutic

No
The device is clearly indicated for diagnostic ultrasound imaging and fluid analysis, not for therapeutic purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic ultrasound imaging." The "Device Description" also refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "general purpose, mobile, software controlled, diagnostic ultrasound system" and mentions the use of "transducers" and a "3D/4D probe," which are hardware components essential for acquiring ultrasound data.

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 "diagnostic ultrasound imaging and fluid analysis of the human body." This describes a medical imaging device that uses ultrasound waves to visualize internal structures and analyze fluids within the body.
• Device Description: The description details how the system acquires and displays ultrasound data in various modes (2D, M, Doppler, etc.) and provides measurement and analysis tools for clinical diagnostic purposes. This aligns with the function of an ultrasound imaging system.
• Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to obtain information about a person's health. The provided information does not mention any analysis of specimens or any components that would perform such analysis.

The "fluid analysis" mentioned in the intended use likely refers to the analysis of fluids within the body as visualized by the ultrasound, such as blood flow analysis using Doppler or the assessment of fluid collections.

Therefore, the SONOACE X8 system is a diagnostic ultrasound imaging system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SONOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:
General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

Product codes

IYN, IYO, ITX

Device Description

The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode.

The SONOACE X8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

Mentions image processing

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal, Ophthalmic, Fetal, Intra-operative, Intra-operative (Neuro.), Laparoscopic, Small Organ (e.g., thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Peripheral vessel, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Cardiac), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Adult Cephalic.

Indicated Patient Age Range

Adult, pediatric, neonatal, fetal.

Intended User / Care Setting

Competent health care professionals.

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)

Not Found

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

Not Found

Predicate Device(s)

K063580, K092159

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

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K093714

510(k) Premarket Notification

SONOACE X8 Diagnostic Ultrasound System

DEC 1 0 2009

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

Contact Person:

Mr. Kyung-Am, Shim Regulatory Affairs Manager

Telephone:	82.2.2194.1381
Facsimile:	82.2.2194.1399
Email:	[e-mail]

Data Prepared: September 7, 2009

2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

SONOACE X8 Diagnostic Ultrasound System

Classification Names:	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

3. Identification of the predicate or legally marketed device:

K063580, SONOACE X8 Diagnostic Ultrasound System K092159, ACCUVIX V20 Diagnostic Ultrasound System

4. Device Description:

The SONOACE X8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode.

The SONOACE X8 has real time acoustic output display with two basic indices, a

1

mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The SONOACE X8 has been designed to meet the following product safety standards:

• UL 60601-1, Safety requirements for Medical Equipment
• CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
• IEC60601-2-37. Diagnostic Ultrasound Safety Standards
• EN/IEC60601-1, Safety requirements for Medical Equipment
• EN/IEC60601-1-2, EMC requirements for Medical Equipment
• NEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
• NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• IEC 61157. Declaration of the acoustic output
• ISO10993-1. Biocompatibility

5. Intended Uses:

The SQNOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include:

General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

6. Technological Characteristics:

The SONOACE X8 is substantially equivalent to the SONOACE X8 Diagnostic Ultrasound System, cleared via K063580, and the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

END of 510(K) Summary

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions, representing health and human services. The figure is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

DEC 1 0 2009

Re: K093714

Trade/Device Name: SONOACE X8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system' Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: December 1, 2009 Received: December 2, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SONOACE X8 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
3D2-6ET	C2-5EP	NEV4-9ES	P2-4AA
3D4-8EK	C2-8	HL5-12ED	P2-4AH
3D4-8ET	C3-7EP	L4-7EL	P3-5AC
3D4-9ES	C4-9/10ED	L5-12/50EP	P3-7AC
3D5-9EK	ER4-9/10ED	L5-12EC	CW 2.0
3DC2-6	EV4-9/10ED	L5-12EP	CW 4.0
C2-5EL	NER4-9ES	MPT4-7

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Page 2 - Mr. Mark Job

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Section 1.3 INDICATIONS FOR USE

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No.:	K093714
Device Name:	SONOACE X8 Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P	P	P	Note 1	Note 2,4,5,6,7,8,9
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2,5,6,8,9
	Neonatal Cephalic	P	P	P	P	P	Note 1
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal	P	P	P	P	P	Note 1	Note 2, 3, 8
	Trans-vaginal	P	P	P	P	P	Note 1	Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)	N	N	N	N	N	Note 1	Note 4, 7
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2,5,6,8,9
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2,5,6,8,9
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)	N	N	N	N	N	Note 1	Note 4, 7
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	Note 1	Note 5, 6, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scroturn and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
---------------------

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K093714
---------------	---------

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510(k) No.:
Device Name:	3D2-6ET for use with SONOACE X8
Intended Use:								Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application
Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
Fetal Imaging
& Other	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
	Peripheral vessel
Peripheral
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K93714

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510(k) No .:

| 3D4-8EK for use with SONOACE X8
Device Name:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
General
(Track I only)	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)	p	p	p		p	Note 1	Notes 2, 7, 8
	Abdominal	p	p	p		p	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	p	p	p		p	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel
  Note 7: Tissue Hannonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Pey 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Dev

510(k) Number

7

510(k) No.:
Device Name:
3D4-8ET for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal	P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Heleum

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological I 510(k) Numbe

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510(k) No .: Device Name: 3D4-9ES for use with SONOACE X8 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific B M PWD CWD Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic Pediatric & Other Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal P P P P Notes 2, 8 Note 1 Trans-vaginal P P Notes 2, 8 P P Note 1 Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler. B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

9

510(k) No.:
Device Name:
3D5-9EK for use with SONOACE X8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Rer 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number

10

510(k) No .:
Device Name:	3DC2-6 for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N		N	Note 1	Notes 2, 7, 8
	Abdominal	N	N	N		N	Note l	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	N	N	N		N	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Hes. Klem

gn-C (fr) (Divisic Division of Reproductive, Abdominal and Radiological D 510(k) Number

11

510(k) No .: Device Name: C2-5EL for use with SONOACE X8 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific B PWD CWD M Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) P P P P Note 1 Notes 2, 7, 8 Abdominal P Notes 2, 7, 8 P P P Note l Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric P P P P Note l Notes 2, 7, 8 Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Sign-0 Division of Reproductive, Abdominal, and Radiological D 510(k) Number

12

510(k) No .: Device Name: C2-5EP for use with SONOACE X8 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Clinical Application Mode of Operation (includes simultaneous B-mode) Specific General B M PWD CWD Color Combined Other (Track I only) (Tracks I & III) Doppler3 (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) N Note 1 Notes 2, 7, 8 N N N Abdominal N N N N Note 1 Notes 2, 7, 8 Intra-operative (See Note 6) Intra-operative (Neuro.) Laparoscopic Fetal Imaging & Other Pediatric N Note 1 Notes 2, 7, 8 N N N Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-csophagcal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological I 510/k) Number

13

510(k) No.:
C2-8 for use with SONOACE X8
Device Name:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Intended Use:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N		N	Note 1	Notes 2, 7, 8
	Abdominal	N	N	N		N	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Herlea

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Dev 510(k) Number

14

510(k) No.:
Device Name:
C3-7EP for use with SONOACE X8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
General
(Track I only)	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
	Specific
(Tracks I & III)		B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)		P	P	P		P	Note 1	Notes 2, 7, 8
	Abdominal		P	P	P		P	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric		P	P	P		P	Note 1	Notes 2, 7, 8
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use(Per 21 CER 801.109)

Hestum

Sign-Off) (Division Division of Reproductive, Abdominal, and Radiclogical Devi 510(k) Numbe

15

510(k) No .:
Device Name:	C4-9/10ED for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	P	P	P		P	Note 1	Note 2, 8
	Abdominal	P	P	P		P	Note 1	Note 2, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		P	Note l	Note 2, 8
	Small Organ (See Note 5)	P	P	P		P	Note l	Note 2, 8
	Neonatal Cephalic	P	P	P		P	Note 1	Note 2, 8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 2, 8
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

16

510(k) No.: Device Name:

| Device Name:

ER4-9/10ED for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)						1
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K093714
---------------	---------

17

PU CHAED C ..

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Darria AT

| Device Traine:
E V4->> TULD for use With SONUACE A8
Intended Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
Abdominal
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
Pediatric
	Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 8
	Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal	P	P	P		P	Note 1	Note 2, 8
	Other (spec.)
Cardiac	Cardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
Vessel	Peripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

• Note 6: Abdominal organs and peripheral vessel
• Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,

Radiological Devices

S/N Number: 093714

18

510(k) No.:
Device Name:
NER4-9ES for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptiop Use (Per 2Y CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological D 510(k) Number

19

510(k) No.:
Device Name: NEV4-9ES for use with SONOACE X8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic
Fetal Imaging
& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 8
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppier/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K093714

20

510(k) No.:
Device Name:
HL5-12ED for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler, B/Power Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Qffice of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Hul

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De 510(k) Number

21

510(k) No.:
Device Name:	L4-7EL for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dey 510(k) Number

22

510(k) No .:
Device Name:	L5-12/50EP for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application						Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
Abdominal
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P		p	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note l	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note l	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note l	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	p		P	Note 1	Note 2, 5, 6, 7, 9
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 2) CFR 801.109)

signature

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological 510(k) Number

23

510(k) No.:
Device Name: L5-12EC for use with SONOACE X8
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De 510(k) Number

24

510(k) No.:
Device Name:	L5-12EP for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription/Use (Per 21CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number

25

510(k) No .: Device Name: MPT4-7 for use with SONOACE X8 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation (includes simultaneous B-mode) General Specific B M PWD CWD Color Combined Other (Track I only) (Tracks I & III) Doppler* (Spec.) (Spec.) Ophthalmic Ophthalmic Fetal (See Note 3) Abdominal Intra-operative (See Note 6) Intra-operative (Neuro.) Fetal Imaging Laparoscopic & Other Pediatric Small Organ (See Note 5) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) P P P P P Note l Note 7, 8 Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Cardiac Pediatric Trans-esophageal (Cardiac) P P P P P Note l Note 7, 8 Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.)

N= new indication; P= previously cleared by FDA K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K093714

26

510(k) No.:
Device Name:	P2-4AA for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	N	N	N	N	N	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	N	N	N	N	N	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	N	N	N	N	N	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CER 801.109)

vision Sign-Off

(Division/Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K093714

27

510(k) No .:

Device Name: P2-4AH for use with SONOACE X8 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

roductive Andominal

510(k) Number

28

510(k) No .:
Device Name:	P3-5AC for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
(Track I only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per/21 CFR 801.109)

Hed

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,

510(k) Number K01211

29

510(k) No.:

510(k) No.:	P3-7AC for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic
	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 4, 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler, B/Power Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Reproductive, Abdominal, and Radiological 510(k) Numbe

30

510(k) No.:
Device Name:
CW 2.0 for use with SONOACE X8
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Signature of

teproductive, Abdominal,

31

510(k) No .:

Device Name: CW 4.0 for use with SONOACE X8 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric				P
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel				P
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K063580; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PW Doppler, B/Color Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler/PW Doppler, B/Color Doppler/Color M

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

Division Sign-Off

Division of Reproductive, Abdominal,
and Radiological Devices