ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM

• K Number: K123001
• Device Name: ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2012-10-26 ( 29 days)
• Product Code: IYN ITX IYO OBJ
• Regulation Number: 892.1550

Intended Use

The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients

Device Description

The Siemens ACUSON X700™ is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

Predicate Devices

K121699, K112596, K113663, K102997

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related terms in the device description or intended use. The focus is on standard ultrasound imaging modes and analysis packages based on established methodologies.

Therapeutic

No
The device is described as an "ultrasound imaging system" and its intended use is for "clinical diagnosis purposes" and "visualization of cardiac and great vessel anatomy and physiology", not for treating medical conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the "Device Description" identifies it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function in acquiring and displaying ultrasound echo data, which involves hardware components like transducers and display screens. While it is software-controlled, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Siemens ACUSON X700™ ultrasound imaging system is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• Device function: The ACUSON X700 is an ultrasound imaging system. It uses sound waves to create images of internal body structures. It does not analyze specimens taken from the body.
• Intended Use: The intended use describes imaging various anatomical sites and providing measurements and analysis for clinical diagnosis. While this information is used for diagnosis, it is derived from in vivo imaging, not in vitro analysis of specimens.
• Device Description: The description details the imaging modes and display capabilities, all related to generating and displaying ultrasound images of the body.

Therefore, the ACUSON X700 falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

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

90-IYN, 90-IYO, 90-ITX, OBJ

Device Description

The Siemens ACUSON X700™ is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac (Adult, Pediatric), Transesophageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological, Urological.

Indicated Patient Age Range

Adult, Pediatric, Neonatal.

Intended User / Care Setting

Physician / Not Found

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)

Since the X700 uses the same technology and principles as existing devices, clinical data is not required.

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

Not Found

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

K121699, K112596, K113663, K102997

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

Not Found

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

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

K123001

ACUSON X700 ™ Ultrasound System 510(k) Submission

510(k) Summary Prepared August 22, 2012

OCT 2 6 2012 Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043 Contact Person: Shelly Pearce [phone] Telephone: [phone] Fax: ACUSON X700™ Ultrasound System Device Name: Common Name: Diagnostic Ultrasound System with Accessories Classification: Requlatory Class: ll Review Category: Tier II Classification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Intravascular Catheter	FR # 870.1200	Product Code OBJ

A. Legally Marketed Predicate Devices

The Siemens ACUSON X700™ Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K121699), ACUSON S2000 ultrasound system (K112596) and Ultrasonix SonixTABLET ultrasound scanner (K113663, K102997).

B. Device Description:

The Siemens ACUSON X700™ is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

C. Intended Use

The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative,

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Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients

D. Substantial Equivalence

The Acuson X700 is substantially equivalent to the Acuson X300, cleared via K121699, and Acuson S2000, cleared via K112596 and SonixTABLET ultrasound scanner cleared via K113663. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

E. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

• UL 60601-1. Safety Requirements for Medical Equipment .
• l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment l
• l AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• l AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• l 93/42/EEC Medical Devices Directive
• 트 Safety and EMC Requirements for Medical Equipment
  • D EN/IEC 60601-1
  • I EN/IEC 60601-1-1
  • EN/IEC 60601-1-2

2

• . EN/IEC 60601-1-4
• EN/IEC 60601-1-6
• EN/IEC 60601-2-18 .
• . EN/IEC 60601-2-25
• I IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility .

Cleared patient contact materials, electrical and mechanical safety are unchanged.

F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the X700 uses the same technology and principles as existing devices, clinical data is not required.

G. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the X700 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The Acuson X700 is verified and validated according to the company's design control process.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 26 2012

Siemens Medical Solutions USA, Inc. - Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K123001

Trade/Device Name: Acuson X700TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO. ITX, and OBJ Dated: September 26, 2012 Received: September 27, 2012

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 Acuson X700™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C1 Curved Array VF10-5 Linear Array VF12-4 Linear Array EC9-4w Convex Array 6C2 Curved Array CW2 CWS AcuNav 8F Intracardiac AcuNav 10F Intracardiac

4

V5Ms TEE 4V1c Phased Array C7F2 Curved Array EV9F4 Curved Array SoundStar 10F SoundStar eco 10F

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 895. 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 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/CDRH/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 Joshua Nipper at [phone].

Sincerely Yours,

Michael O'Brien for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure(s)

5

Tab 1.3.1 Indications for Use Forms

Indications for Use Statement

510(k) Number (if known):

ACUSON X700™ Diagnostic Ultrasound System Device Name:

Indications For Use:

The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatai Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeleta! Conventional, Musculoskeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arnhard Döhmen

Office of In Vitro Diagnostic Devices

510(k) K123061

Page 1 of __

6

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems

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

Clinical Application	Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,12,19,21
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10,11,20
	Intra-operative
(Note 6)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,9,10
	Intra-operative
(Neuro)
Fetal	Laparoscopic
Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10,11
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11,19
	Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,9,10,11
	Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10,19
	Trans-vaginal	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10,12,19, 21
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	p		P	P	BMDC	Note 2,3,4,9,10,11
	Musculo-skel.
(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Intra -vascular	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,7,8,9, 13, 14,15,16,17,18,19
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6,8,9,10,13,14,15,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,7,9,14,17,18,19
	Intra-Cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	p	BMDC	Note 2,3,4,6,9,10,11
Vessel	Other (Specify)

N = new indication; P = previously cleared by K121699, K112596

Office of In Vitro

Division Sign-Off

510(k)

Diagnostic Devices

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Note 2 Dynamic TCE Technology Note 12 syngo Auto OB Measurements syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging SieScape Panoramic Imaging Note 10 Note 20 Contrast Agent Imaging syngo Auto follicle Note 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Page 2 of

7

510(k) Number (if known):

Device Name:

Intended Use:

4C1 Curved Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10,20
	Intra-operative
(Note 6)	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal ·
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
Vessel	Other (Specify)

N = new indication; P = previously cleared by K112596

Note 11 syngo Arterial Health Package (AHP) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. syngo Auto OB Measurements Note 12 Dynamic TCE Technology Note 2 syngo Auto Left Heart (Auto LH) Technology SieClear Note 13 Note 3 syngo Velocity Vector Imaging Technology Note 14 Advanced SieClear Note 4 Note 15 CartoSound Communication Note 5 3-Scape 3D Imaging Intracardiac Echocardiography (ICE) Imaging Note 6 For example: abdominal, vascular Note 16 Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging Note 10 SieScape Panoramic Imaging Note 21 syngo Auto follicle (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K123001

Page 3 of

8

510(k) Number (if known):

Device Name:

VF10-5 Linear Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Neonatal Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Musculo-skel.
(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
	Other (Specify)

N = new indication; P = previously cleared K121699

Note 11 syngo Arterial Health Package (AHP) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. syngo Auto OB Measurements Note 2 Dynamic TCE Technology Note 12 syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 16 Intracardiac Echocardiography (ICE) Imaging For example: abdominal, vascular Note 6 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 7 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 8 syngo fourSinght 4D imaging Clarify Vascular Enhancement Technology Note 19 Note 9 Note 20 Contrast Agent Imaging Note 10 SieScape Panoramic Imaging syngo Auto follicte Note 21 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

( Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

concurrence
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Page 4 of

9

510(k) Number (if known):

Device Name:

Intended Use:

VF12-4 Linear Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Abdominal
		N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
Imaging
& Other	SmallOrgan
(Note 1)	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Musculo-skel.
(Superfic)	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N	N	N	N	BMDC	Note 2,3,4,9,10,11
Vessel	Other (Specify)

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Note 2 Dynamic TCE Technology

• Note 3 SieClear Note 4 Advanced SieClear
• Note 5 3-Scape 3D Imaging
• Note 6 For example: abdominal, vascular
• Note 7 Stress Echo Imaging
• Note 8 Axius Edge Assisted Ejection Fraction
• Clarify Vascular Enhancement Technology Note 9

• SieScape Panoramic Imaging Note 10

• Note 11 syngo Arterial Health Package (AHP)
• Note 12 syngo Auto OB Measurements
• Note 13 syngo Auto Left Heart (Auto LH) Technology
• Note 14 syngo Velocity Vector Imaging Technology
• Note 15 CartoSound Communication
• Intracardiac Echocardiography (ICE) Imaging Note 16
• Note 17 syngo fourSight TEE View
• Note 18 syngo Mitral Valve Assessment (MVA)
• Note 19 syngo fourSinght 4D imaging
• Note 20 Contrast Agent Imaging Note 21 syngo Auto follicle

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) K123001

10

510(k) Number (if known):

Device Name: Intended Use:

EC9-4w Convex Array Transducer for use with: ACUSON 7300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation Other Power Combined Other Color Specific B M PWD CWD ( Track 1 Dopoler (Specify) Doppler (Specify) (Tracks11& 3) Only) Ophthalmic Ophthalmic N BMDC Note 2,3,4,5,6,9,10,12, 21 Fetal N Z ਮ N Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan BMDC મ N N N N Note 2,3,4,5,9,10 & Other (Note 1) BMDC Note 2,3,4,5,9,10 Neonatal Cephalic N N પ N N Adult Cephalic Trans-rectal N N N N N BMDC Note 2,3,4,5,9,10 . N N ਮ BMDC Note 2,3,4,5,9,10,12, 21 Trans-vaginal N N Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-Cardiac Other (Specify) Peripheral Peripheral vessel Other (Specify) Vessel N = new indication; P = previously cleared

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Dynamic TCE Technology Note 2 Note 12 syngo Auto OB Measurements Note 3 SieClear Note 13 syngo Auto Left Heart (Auto LH) Technology Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction syngo Mitral Valve Assessment (MVA) Note 18 Clarify Vascular Enhancement Technology Note g Note 19 syngo fourSinght 4D imaging Note 10 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Concurrence d
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Page 6 of _

11

510(k) Number (if known):

Device Name:

6C2 Curved Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Intra-operative
(Note 6)	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Intra-operative
(Neuro)
Fetal	Laparoscopic
	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Other (Specify)

N = new indication; P = previously cleared K112596

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

• Note 2 Dynamic TCE Technology

• Note 3 SieClear

• Note 4 Advanced SieClear 3-Scape 3D Imaging

• Note 5 For example: abdominal, vascular Note 6

• Stress Echo Imaging Note 7

• Axius Edge Assisted Ejection Fraction Note 8

• Clarify Vascular Enhancement Technology Note 9

• Note 10 SieScape Panoramic Imaging

• Note 15 CartoSound Communication Note 16 Intracardiac Echocardiography (ICE) Imaging Note 17 syngo fourSight TEE View Note 18 syngo Mitral Valve Assessment (MVA) syngo fourSinght 4D imaging Note 19
  syngo Arterial Health Package (AHP)

syngo Auto Left Heart (Auto LH) Technology

syngo Velocity Vector Imaging Technology

syngo Auto OB Measurements

• Contrast Agent Imaging Note 20
• Note 21 syngo Auto follicle

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Note 11

Note 12

Note 13

Note 14

Division Sign-Off - Office of in Vitro Diagnostic Devices
510(k) K123001

12

510(k) Number (if known):

CW2 Continuous Wave Doppler Transducer for use with:

ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal				P
	Abdominal				P
	Intra-operative
(Note 6)				P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric				P
	SmallOrgan
(Note 1)				P
	Neonatal Cephalic				P
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel				P
	Other (Specify)

N = new indication; P = previously cleared K121699

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

Note 2 Dynamic TCE Technology

• SieClear Note 3

• Advanced SieClear Note 4

• 3-Scape 3D Imaging Note 5

• Note 6 For example: abdominal, vascular

• Note 7 Stress Echo Imaging

• Axius Edge Assisted Ejection Fraction Note 8 Note 9 Clarify Vascular Enhancement Technology

• Note 10 SieScape Panoramic Imaging

• Note 11 syngo Arterial Health Package (AHP)
  Note 12 syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology Note 13

• syngo Velocity Vector Imaging Technology Note 14
• CartoSound Communication Note 15

Note 16 Intracardiac Echocardiography (ICE) Imaging

• syngo fourSight TEE View Note 17
• Note 18 syngo Mitral Valve Assessment (MVA) syngo fourSinght 4D imaging
• Note 19 Note 20 Contrast Agent Imaging
• Note 21 syngo Auto follicie

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR
Division Sign-Off - Offfc Office of in Vitro Diagnostic Devices
510(k) K123001

13

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with:

ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1&3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal				P
	Abdominal				P
	Intra-operative
(Note 6)				P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric				P
	SmallOrgan
(Note 1)				P
	Neonatal Cephalic				P
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel				P
	Other (Specify)

N = new indication; P = previously cleared K121699

syngo Arterial Health Package (AHP) For example: breast, testes, thyroid, penis, prostate, etc. Note 11 Note 1 syngo Auto OB Measurements Note 2 Dynamic TCE Technology Note 12 syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Stress Echo Imaging Note 17 syngo fourSight TEE View Note 7 Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging Note 10 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001

Page 9 of

14

510(k) Number (if known):

AcuNav 8F Intracardiac Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared K121699

For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Note 1 syngo Auto OB Measurements Dynamic TCE Technology Note 12 Note 2 syngo Auto Left Heart (Auto LH) Technology Note 13 Note 3 SieClear syngo Velocity Vector Imaging Technology Note 14 Advanced SieClear Note 4 CartoSound Communication Note 15 Note 5 3-Scape 3D Imaging Intracardiac Echocardiography (ICE) Imaging Note 16 Note 6 For example: abdominal, vascular syngo fourSight TEE View Note 17 Note 7 Stress Echo Imaging syngo Mitral Valve Assessment (MVA) Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo fourSinght 4D imaging Clarify Vascular Enhancement Technology Note 19 Note 9 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging Note 10 Note 21 syngo Auto follicle (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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15

510(k) Number (if known):

Device Name:

Intended Use:

AcuNav 10F Intracardiac Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,16
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
• Note 3 SieClear
• Advanced SieClear Note 4
• 3-Scape 3D Imaging Note 5
• For example: abdominal, vascular Note 6
• Note 7 Stress Echo Imaging
• Axius Edge Assisted Ejection Fraction Note 8 Clarify Vascular Enhancement Technology
• Note 9 Note 10 SieScape Panoramic Imaging
• syngo Auto OB Measurements Note 12
• syngo Auto Left Heart (Auto LH) Technology Note 13 Note 14 syngo Velocity Vector Imaging Technology

syngo Arterial Health Package (AHP)

• Note 15 CartoSound Communication
• Note 16 Intracardiac Echocardiography (ICE) Imaging
• syngo fourSight TEE View Note 17
• Note 18 syngo Mitral Valve Assessment (MVA)
• Note 19 syngo fourSinght 4D imaging
• Contrast Agent Imaging Note 20
• syngo Auto follicle Note 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 11

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) 123001

16

510(k) Number (if known):

V5Ms TEE Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

iagnostic imaging or fluid flow analysis of the human body as

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

Clinical Application		Mode of Operation
Other
(Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,7,9,14,17,18,19
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,7,9,14,17,18,19
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared K121699

Note 11 syngo Arterial Health Package (AHP) For example: breast, testes, thyroid, penis, prostate, etc. Note 1 syngo Auto OB Measurements Dynamic TCE Technology Note 12 Note 2 syngo Auto Left Heart (Auto LH) Technology Note 13 Note 3 SieClear syngo Velocity Vector Imaging Technology Note 14 Advanced SieClear Note 4 Note 15 CartoSound Communication Note 5 3-Scape 3D Imaging Intracardiac Echocardiography (ICE) Imaging For example: abdominal, vascular Note 16 Note 6 syngo fourSight TEE View Note 17 Note 7 Stress Echo Imaging syngo Mitral Valve Assessment (MVA) Note 8 Axius Edge Assisted Ejection Fraction Note 18 Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging SieScape Panoramic Imaging Note 20 Contrast Agent Imaging Note 10 Note 21 syngo Auto follicle (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) K123001

17

・・

510(k) Number (if known):

Device Name: Intended Use:

4V1c Phased Sector Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation Other Combined Other Specific Color Power B PWD CWD M ( Track 1 (Tracks11& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Note 2,9 Fetal P P P P P BMDC P P Note 2,9 P P P BMDC Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric . Imaging . SmallOrgan & Other (Note 1) . P P P b BMDC Note 2,9 Neonatal Cephalic P P P P P P P P BMDC Note 2,9 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) P Cardiac Adult P P P P P BMDC Note 2,7,8,9, 13, 14 Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Periphera! Peripheral vessel Vessel Other (Specify)

N = new indication; P = previously cleared K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology

• SieClear Note 3 Advanced SieClear Note 4

• 3-Scape 3D Imaging Note 5

• Note 6 For example: abdominal, vascular

• Note 7 Stress Echo Imaging

• Axius Edge Assisted Ejection Fraction Note 8

• Note 9 Clarify Vascular Enhancement Technology

• Note 10 SieScape Panoramic Imaging

• syngo Auto OB Measurements Note 12 Note 13 syngo Auto Left Heart (Auto LH) Technology Note 14 syngo Velocity Vector Imaging Technology Note 15 CartoSound Communication Intracardiac Echocardiography (ICE) Imaging Note 16 syngo fourSight TEE View Note 17 syngo Mitral Valve Assessment (MVA) Note 18 Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging Note 21 syngo Auto follicle
  syngo Arterial Health Package (AHP)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Note 11

(Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
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Page 13 of _

18

510(k) Number (if known):

.

Device Name:

C7F2 Curved Array Mechanical 3D/4D Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,12,19
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
Fetal	Laparoscopic
	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6,9,10
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared K121699

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo Arterial Health Package (AHP)
Note 2	Dynamic TCE Technology	Note 12	syngo Auto OB Measurements
Note 3	SieClear	Note 13	syngo Auto Left Heart (Auto LH) Technology
Note 4	Advanced SieClear	Note 14	syngo Velocity Vector Imaging Technology
Note 5	3-Scape 3D Imaging	Note 15	CartoSound Communication
Note 6	For example: abdominal, vascular	Note 16	Intracardiac Echocardiography (ICE) Imaging
Note 7	Stress Echo Imaging	Note 17	syngo fourSight TEE View
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo Mitral Valve Assessment (MVA)
Note 9	Clarify Vascular Enhancement Technology	Note 19	syngo fourSight 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging
		Note 21	syngo Auto follicle

.

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001

Page 14 of ___________________________________________________________________________________________________________________________________________________________________

UE OI ANOTHEF

19

510(k) Number (if known):

EV9F4 Curved Array Mechanical 3D/4D Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

| Other
(Track1
Only) | Specific
(Tracks 1& 3) | Mode of Operation | | | | | | | Other
(Specify) |
|-----------------------------|-----------------------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|-----------------------------|
| | | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,12, 19, |
| | Abdominal | | | | | | | | |
| | Intra-operative
(Note 6) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | | | | | | | | |
| | SmallOrgan
(Note 1) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,19 |
| | Trans-vaginal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,12,19, 21 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify)
N = new indication; P = previously cleared K121699 | | | | | | | | |

For example: breast, testes, thyroid, penis, prostate, etc. Note 1 syngo Arterial Health Package (AHP) Note 11 Dynamic TCE Technology Note 2 Note 12 syngo Auto OB Measurements Note 3 SieClear syngo Auto Left Heart (Auto LH) Technology Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging Note 10 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office in Vitro Diagnostic Devices
510(k)/2123001

Page 15 of _

20

510(k) Number (if known):

SoundStar 10F Transducer for use with:

ACUSON X700 Diagnostic Ultrasound Systems

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared K121699

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

• Note 2 Dynamic TCE Technology
  Note 3 SieClear

• Note 4 Advanced SieClear
  3-Scape 3D Imaging Note 5

• Note 6 For example: abdominal, vascular

• Stress Echo Imaging Note 7 Note 8

• Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology

• Note 10

• SieScape Panoramic Imaging

• Note 11 syngo Arterial Health Package (AHP) Note 12 syngo Auto OB Measurements

• Note 13 syngo Auto Left Heart (Auto LH) Technology

• Note 14 syngo Velocity Vector Imaging Technology

• CartoSound Communication Note 15

• Note 16 Intracardiac Echocardiography (ICE) Imaging

• Note 17 syngo fourSight TEE View

• Note 18 syngo Mitral Valve Assessment (MVA)

• Note 19 syngo fourSinght 4D imaging

• Note 20 Contrast Agent Imaging

• syngo Auto follicle Note 21

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001

21

510(k) Number (if known):

Device Name:

SoundStar eco 10F Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems

Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular	N	N	N	N	N	N	BMDC	Note 2,8,9,13,14,15,16
	Other
(Specify)
	Cardiac Adult	N	N	N	N	N	N	BMDC	Note 2,8,9,13,14,15,16
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	BMDC	Note 2,8,9,13,14,15,16
	Intra-vascular
(Cardiac)	N	N	N	N	N	N	BMDC	Note 2,8,9,13,14,15,16
	Trans-esophageal
(Cardiac)
	Intra-cardiac	N	N	N	N	N	N	BMDC	Note 2,8,9,13,14,15,16
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

Dynamic TCE Technology Note 2

• Note 3 SieClear

• Advanced SieClear Note 4

• 3-Scape 3D Imaging Note 5

• For example: abdominal, vascular Note 6

• Note 7 Stress Echo Imaging

• Note 8 Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology

• Note 10 SieScape Panoramic Imaging

• Note 15 CartoSound Communication Note 16 Intracardiac Echocardiography (ICE) Imaging Note 17 syngo fourSight TEE View Note 18 syngo Mitral Valve Assessment (MVA) Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21
  syngo Arterial Health Package (AHP)

syngo Auto Left Heart (Auto LH) Technology

syngo Velocity Vector Imaging Technology

syngo Auto OB Measurements

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Note 11

Note 12

Note 13

Note 14

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k) K123001

Page 17 of ___________________________________________________________________________________________________________________________________________________________________