The SONOACE X8 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Pediatric Cardiology, TCD, Cardiac, Small parts, Vascular, Muscularskeletal, Pediatric Abdomen, OB, Gynecology, Urology, Pediatric Cardiac, Adult Cardiac, Pediatric and Appendix applications.

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 imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3D imaging mode using the 3D 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.

AI/ML Overview

The provided document is a 510(k) Summary for the SONOACE X8 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses and technical characteristics. Critically, the provided text does not contain any information regarding acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document states that "The SONOACE X8 Diagnostic Ultrasound System is substantially equivalent to the ACCUVIX XQ Diagnostic Ultrasound System, cleared via K052911, and the SA8000 Diagnostic Ultrasound System, cleared via K013627." Substantial equivalence is the primary pathway for clearance of medical devices by the FDA, meaning that the new device has the same intended use as a legally marketed predicate device and has similar technological characteristics to the predicate device. If the new device has different technological characteristics than the predicate device, it does not raise different questions of safety and effectiveness.

Therefore, the "studies" mentioned in this document are primarily focused on outlining the technical specifications and clinical applications for which the device and its various transducers are intended to be used, and comparing these to predicate devices. There is no performance study with quantifiable acceptance criteria and results described.

Based on the provided text, the following information can be extracted regarding the lack of specified acceptance criteria and performance study details:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

No test set sample size or data provenance is mentioned as there is no performance study described.

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

Not applicable, as no ground truth establishment for a test set is described.

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

Not applicable, as no test set or adjudication is described.

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

No MRMC comparative effectiveness study was performed or described. This is a diagnostic ultrasound system, not an AI-powered analytical tool.

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

Not applicable, as this is a medical imaging device and not an AI algorithm.

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

Not applicable, as no ground truth is mentioned in the context of a performance study. The "ground truth" for this type of device is regulatory compliance and functional equivalence to predicate devices.

8. The sample size for the training set:

Not applicable, as this is a general purpose diagnostic ultrasound system, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this device.

Summary

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DEC 1 4 2006

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:	kashim@medison.com

Data Prepared: October 25, 2006

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	90-IYN
Ultrasound Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3. Identification of the predicate or legally marketed device:

K052911, 10/31/2005, ACCUVIX XQ Diagnostic Ultrasound System K013627, 11/16/2001, SA8000 Diagnostic Ultrasound System

4. Device Description:

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

510(k) Summary of Safety and Effectiveness

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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 v
NEMA UD 2-2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
NEMA UD 3-2004 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
IEC 61157, Declaration of the acoustic output
ISO10993. Biocompatibility

5. Intended Uses:

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

The clinical applications include:

Abdomen, Pediatric Cardiology, TCD, Cardiac, Small parts, Vascular, Muscularskeletal, Pediatric Abdomen, OB, Gynecology, Urology, Pediatric Cardiac, Adult Cardiac, Pediatric and Appendix applications.

6. Technological Characteristics:

The SONOACE X8 is substantially equivalent to the ACCUVEX XQ Diagnostic Ultrasound System, cleared via K052911, and the SA8000 Diagnostic Ultrasound System, cleared via K013627. 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/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, graphic style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063580

Trade Name: SONOACE X8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 27, 2006 Received: November 30, 2006

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.

DEC 1 4 2006

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:

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular and contains the letters "FDA" in the center. The text "1906-2006" is at the top of the logo. The words "Protecting and Promoting Public Health" are written in a fancy font below the logo.

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Transducer Model Number

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

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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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

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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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang at (240) 276-3666.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon 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 4.3 INDICATIONS FOR USE

DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No.: K063580
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	ColorDoppler*	Combined*(Spec.)Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)	N	N	N	N	N	Note 1Notes 2, 7, 8
	Abdominal	N	N	N	N	N	Note 1Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1Note 2,4,5,6,7,8,9
	Small Organ (See Note 5)	N	N	N	N	N	Note 1Note 2,5,6,8,9
	Neonatal Cephalic	N	N	N	N	N	Note 1
	Adult Cephalic	N	N	N	N	N	Note 1Note 4, 7
	Trans-rectal	N	N	N	N	N	Note 1Note 2, 3, 8
	Trans-vaginal	N	N	N	N	N	Note 1Note 2, 3, 8
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	N	N	N	N	N	Note 1Note 2,5,6,8,9
	Musculo-skel. (Superfic.)	N	N	N	N	N	Note 1Note 2,5,6,8,9
	Intra-luminal
	Other (spec.)
Cardiac	Cardiac Adult	N	N	N	N	N	Note 1Note 4, 7
	Cardiac Pediatric	N	N	N	N	N	Note 1Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1Note 5, 6, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

00/AX00/VCJ

Nancy Brogdon

(Division Siring Division of Reproductive, I and Radiological Devices 51()(k) Number _______________________________________________________________________________________________________________________________________________________________

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510(k) No.:	K063580
Device Name:	3D2-5EHfor 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	ColorDoppler*	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
		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	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (spec.)
PeripheralVessel		Peripheral vessel
		Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Swogdon

(Division Sign-Off Division of Reproductive, Al and Radiological Devices 510(k) Number __

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510(k) No.:	K063580
Device Name:	3D2-5ELfor 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	ColorDoppler*	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 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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C Broadon
(Division Sign-Off)

Division of Reproductive, Abdg and Radiological Devices 510(k) Number

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510(k) No.:	K063580
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	ColorDoppler*	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 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
Fetal Imaging& Other	Intra-operative (Neuro.)
	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
Cardiac	Other (spec.)
	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Brogdon

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

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

510(k) No.:	K063580
Device Name:	3D4-8EK 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	ColorDoppler*	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 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	Cardiac Adult
		Cardiac Pediatric
		Trans-esophageal (Cardiac)
		Other (spec.)
PeripheralVessel		Peripheral vessel
		Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580

{10}------------------------------------------------

510(k) No.:	K063580
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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
	Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)		N	N	N	N	N	Note 1	Notes 2, 7, 8
	Abdominal		N	N	N	N	N	Note 1	Notes 2, 7, 8
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD

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

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580

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KO63580 510(k) No.: Device Name: 3D4-9ES 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 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 Notes 2, 8 N N N Note l N Trans-vaginal N Notes 2, 8 N N N 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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD

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)

Nancy C Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
VV063580

510(k) Number

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510(k) No.:	K063580
Device Name:	3D5-9EK for use with SONOACE X8
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation (*includes simultaneous B-mode)
	Clinical Application	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	Note 1	Notes 2, 8
	Trans-vaginal	N	N	N		N	Note 1	Notes 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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K1106580

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

2063580

510(k) No .: C2-4ES 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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	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	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	P	P	P	P	P	Note 1	Notes 2, 7, 8
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 2, 7, 8
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K063580

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

510(k) No.:	K063580
Device Name:	C2-5EL 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	ColorDoppler*	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
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD 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)

510(k) Number __

Nancy Broughton
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 1/26/3580

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

510(k) No.:	K063580
Device Name:	C3-7EP 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 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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Brandon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580

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

510(k) No.:	K063580
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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(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& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Note 2, 8
	Small Organ (See Note 5)	P	P	P		P	Note 1	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.)
PeripheralVessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 8
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy Hodgson
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) No.:	K063580
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)						Other(Spec.)
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)AbdominalIntra-operative (See Note 6)Intra-operative (Neuro.)
Fetal Imaging& Other	LaparoscopicPediatric
	Small Organ (See Note 5)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginal	NN	NN	NN		NN	Note 1Note 1	Note 2, 8Note 2, 8
	Trans-urethralTrans-esoph. (non-Cardiac)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.)
Cardiac	Cardiac AdultCardiac PediatricTrans-esophageal (Cardiac)Other (spec.)
PeripheralVessel	Peripheral vesselOther (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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,
ano Radiological Devices/

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

510(k) No.:	K063580
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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	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	N	N	N		N	Note 1	Note 2, 8
	Trans-vaginal	N	N	N		N	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.)

PeripheralVessel	Peripheral vesselOther (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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-Offy
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number -

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

510(k) No.:	K063580
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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 5, 6, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Sign-Off)
(Division Sign-Off)
Nancy C. Brogdon
Division of Reproductive, Abdominal.
and Radiological Devices
K063588
$10(k) Number

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

510(k) No.:	K063580
Device Name:	L4-7EH 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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
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, 9
	Small Organ (See Note 5)	N	N	N		N	Note 1	Note 2, 5, 6, 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, 9
	Musculo-skel. (Superfic.)	N	N	N		N	Note I	Note 2, 5, 6, 9
	Intra-luminal
	Other (spec.)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 5, 6, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KK063580

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

510(k) No.:	K063580
L5-12/50EP for use with SONOACE X8Device Name:
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	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging& Other	Laparoscopic
	Pediatric	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Small Organ (See Note 5)	N	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	N	Note 1	Note 2, 5, 6, 7, 9
	Musculo-skel. (Superfic.)	N	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.)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancy C. Brogdon
Division Sign-Off

f Reproductive, Abdominal,
Devices
K163570

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

510(k) No.:	K063580
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	Specific	B	M	PWD	CWD	ColorDoppler*	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.)
PeripheralVessel	Peripheral vessel	N	N	N		N	Note 1	Note 2, 5, 6, 7, 9
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/C/M/Color Doppler, B/PWD/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices * 10%) Number

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

K	063580
---	--------

510(k) No.: Device Name: P2-4AC 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)	Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD 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

Nancy C. Brogdon
(Division Sign-Off)

(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K163580

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

510(k) No.:	K063580
Device Name:	P2-4AH 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 ApplicationSpecific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	Combined*(Spec.)	Other(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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.)
PeripheralVessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/C/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/L/

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

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K(K) Number 1063588

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

510(k) No.:	K063580
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	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(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	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 K052911; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nancyc Brogdon
(Division Sign-Off)/
Division of Reproductive, Abdominal,
and Radiological Devices
K163580
510(K) Number

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510(k) No.:	K063580
Device Name:	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)
	B	M	PWD	CWD	Color Doppler*	Combined* (Spec.)	Other (Spec.)
General(Track I only)	Specific(Tracks I & III)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal (See Note 3)
	Abdominal	P	P	P	P	P	Note 1	Note 4, 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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) Onliston of Reproductive, A ୍ୟାନ୍ୟ Radiological Devices 510k) Number _________________________________________________________________________________________________________________________________________________________________

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< 063580

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 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 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 Peripheral vessel P Vessel Other (spec.) p

N= new indication; P= previously cleared by K052911 and K032329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler, B/Color Doppler/CWD

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

Nanca Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063580

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

510(k) No.:	K063580
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(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler*	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
	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.)
PeripheralVessel	Peripheral vessel				P
	Other (spec.)

N= new indication; P= previously cleared by K052911 and K013627; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B/M, B/PWD, B/CWD, B/Color Doppler, B/M/Color Doppler, B/PWD/Color Doppler/CWD

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

Nancy C Hogdon
(Division Sign-Off)

Division of Reproductive, Al and Radiological Devices, 510(k) Number ................................................................................................................................................................

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.