Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging and analysis features, with no mention of AI or ML technologies. The "Arterial Health Package" is described as a measurement and referencing tool, not an AI/ML-driven analysis.

Therapeutic

No.
The device is described as an "ultrasound imaging system" intended for "clinical diagnosis purposes" and "visualization," which are diagnostic functions, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system "provides information that is used for clinical diagnosis purposes." Additionally, the "Device Description" directly refers to the system as "diagnostic ultrasound systems."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and mentions transmitting ultrasonic energy, receiving echoes, and displaying images, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). The description clearly states that this device transmits ultrasonic energy into patients and processes the received echoes to generate images of structures within the body.
The intended use and device description focus on imaging and measurement in vivo (within the living body). All the listed applications and the description of how the device works involve directly interacting with the patient's body to produce images and measurements.
There is no mention of analyzing biological samples. The text describes ultrasound imaging and related measurements, not the analysis of bodily fluids or tissues.

Therefore, the Siemens ACUSON X700™ and X600™ ultrasound imaging system, as described, is a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Siemens ACUSON X700™ and X600 ™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, 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 and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal 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)

IYN, IYO, ITX, OBJ

Device Description

The Siemens ACUSON X700™ and X600™ are multi-purpose mobile, software controlled, diagnostic ultrasound systems 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, 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, Transesphageal, Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Intra-operative, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological, Urological. Specific transducers are indicated for: Fetal, Pediatric, Trans-rectal, Trans-vaginal, Intra-vascular.

Indicated Patient Age Range

Adult, Pediatric, Neonatal

Intended User / Care Setting

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)

Nonclinical tests submitted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic and mechanical safety. The device conforms with applicable medical device safety standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 62304, EN/IEC 62366, EN/IEC 60601-2-18, EN/IEC 60601-2-25, ISO 10993-1. Clinical data was not required as the device uses the same technology and principles as existing devices.

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.

K123001, K112596, K121699, K132804

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

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

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

August 7, 2014

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW BUFFALO MN 55313

Re: K141846

Trade/Device Name: Acuson X700™ and Acuson X600™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: July 8, 2014 Received: July 9, 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Acuson X700 and Acuson X600 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

4C1	AcuNav 10F	C6F2
VF10-5	V5Ms	C8F3
VF12-4	4V1c	EV9F3
EC9-4w	C7F2	C8-5
6C2	EV9F4	P8-4
CW2	SoundStar 10F	MC9-4
ું જિલ્લાના એક એવા ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની ખેત-ઉપયોગના મધ્યમાં આવેલું એક ગામનાં મુખ્યત્વે તેમ જ દૂધની	SoundStar eco 10F	CH5-2
AcuNav 8F	VF16-5	C6-2
SoundStar eco 8F

1

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.f)

for

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

Enclosure

2

Indications for Use

510(k) Number (if known): K141846

ACUSON X700™ and X600 ™ Diagnostic Ultrasound System Device Name:

Indications For Use:

The Siemens ACUSON X700™ and X600 ™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, 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 and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Type of Use (Select one or both, as applicable)

X Prescription Use (21 CFG 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

FOR FDA USE ONLY

FDA

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

3

510(k) Number (if known): K141846

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
( 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 2,3,4,5,6,9,10,12,19,21
	Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11,12,20,22
	Intra-operative
(Note 6)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative
(Neuro)									Note 2,3,4,5,6,9,10
	Laparoscopic
Fetal
Imaging
& Other	Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
	SmallOrgan
(Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11,19, 22
	Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
	Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
	Trans-rectal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,19
	Trans-vaginal		P	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	P	BMDC	Note 2,3,4,5,6,9,10,11,22
	Musculo-skel.
(Superfic)		P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11,22
	Intra -vascular		P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Other
(Specify)
Cardiac	Cardiac Adult		P	P	P	P	P	P	BMDC	Note 2,7,8,9, 13,14,15,16,17,18,19
	Cardiac Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,8,9,10,13,14,15,16
	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
Vessel	Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
	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 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
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

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

Note 20 Contrast Agent Imaging
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k) K141846

Page 2 of 28

4

510(k) Number (if known): K141846

ACUSON X600 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	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 2,3,4,5,6,9,10,11,12,20
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
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 2,3,4,5,6,9,10,11
	Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
	Trans-rectal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,19
	Trans-vaginal	P	P	P	P	P	P	BMDC	Note 2,3,4,5,9,10,12,19
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,5,6,9,10,11
	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 2,3,4,5,6,8,9,10,13,14,15,16
	Intra-vascular
(Cardiac)	P	P	P	P	P	P	BMDC	Note 2,8,9,13,14,15,16
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,9,10,11
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
Advanced SieClear Note 4
Note 5 3-Scape 3D Imaging For example: abdominal, vascular Note 6
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)
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 Note 18 syngo Mitral Valve Assessment (MVA)

Note 19 syngo fourSinght 4D imaging
Note 20 Contrast Agent Imaging
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k) K141846

Page 3 of 28

5

510(k) Number (if known): K141846

Device Name:

4C1 Curved Array 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
	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

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 fourSinght 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging
		Note 21	syngo Auto follicle (X700 only)
		Note 22	eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 4 of 28

6

510(k) Number (if known): K141846

Device Name:

VF10-5 Linear Array Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 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
(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	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,9,10,11,22
	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	Peripheral vessel	P	P	P		P	P	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-Scane 3D Imaging

Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

Note 8 Axius Edge Assisted Ejection Fraction

Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging

syngo Arterial Health Package (AHP) Note 11 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

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 Note 20 Contrast Agent Imaging

Note 21 syngo Auto follicle (X700 only)

Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 5 of 28

7

510(k) Number (if known): K141846

Device Name:

VF12-4 Linear Array Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 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
(Tracks1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)						-
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11,22
	Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,3,4,9,10,11
	Adult Cephalic	P	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	P	BMDC	Note 2,3,4,9,10,11
	Musculo-skel.
(Superfic)	P	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	Peripheral vessel	P	P	P	P	P	P	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.
TO

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
Note 8 Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging
syngo Arterial Health Package (AHP) Note 11 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

Intracardiac Echocardiography (ICE) Imaging Note 16

Note 17 syngo fourSight TEE View syngo Mitral Valve Assessment (MVA)
Note 18
Note 19 syngo fourSinght 4D imaging Note 20
- Contrast Agent Imaging
Note 21 syngo Auto follicle (X700 only) Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 6 of 28

8

510(k) Number (if known): K141846

Device Name:

EC9-4w Convex Array Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems 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	BMDC	Note 2,3,4,5,6,9,10,12, 21
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10
	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
	Trans-vaginal	P	P	P		P	P	BMDC	Note 2,3,4,5,9,10,12, 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

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 fourSinght 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging
		Note 21	syngo Auto follicle (X700 only)
		Note 22	eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 7 of 28

9

510(k) Number (if known): K141846

| 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
( Track 1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,12 | | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-operative
(Note 6) | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-operative
(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | 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 | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| Vessel | Other (Specify) | | | | | | | | | | |

N = new indication; P = previously cleared

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo Arterial
Note 2	Dynamic TCE Technology	Note 12	syngo Auto OB
Note 3	SieClear	Note 13	syngo Auto Left
Note 4	Advanced SieClear	Note 14	syngo Velocity
Note 5	3-Scape 3D Imaging	Note 15	CartoSound Co
Note 6	For example: abdominal, vascular	Note 16	Intracardiac Ec
Note 7	Stress Echo Imaging	Note 17	syngo fourSight
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo Mitral Va
Note 9	Clarify Vascular Enhancement Technology	Note 19	syngo fourSing
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent
		Note 21	syngo Auto follic
		Note 22	eSie Touch (X7

lealth Package (AHP)

lote 12 syngo Auto OB Measurements

Measurements
t Heart (Auto LH) Technology

Vector Imaging Technology

ommunication

hocardiography (ICE) Imaging TEE View

lve Assessment (MVA)

ht 4D imaging

Note 20 Contrast Agent Imaging

t Imaging
icle (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 8 of 28

10

510(k) Number (if known): K141846

Device Name:
--------------	--

CW2 Continuous Wave Doppler Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems 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	Pediatric				P
Imaging
& Other	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	Peripheral vessel				P
Vessel	Other (Specify)

N = new indication; P = previously cleared

| Note 1
Note 2
Note 3
Note 4
Note 5
Note 6
Note 7
Note 8
Note 9
Note 10 | For example: breast, testes, thyroid, penis, prostate, etc.
Dynamic TCE Technology
SieClear
Advanced SieClear
3-Scape 3D Imaging
For example: abdominal, vascular
Stress Echo Imaging
Axius Edge Assisted Ejection Fraction
Clarify Vascular Enhancement Technology
SieScape Panoramic Imaging | Note 11
Note 12
Note 13
Note 14
Note 15
Note 16
Note 17
Note 18
Note 19
Note 20
Note 21
Note 22 | syngo Arterial Health Package (AHP)
syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology
syngo Velocity Vector Imaging Technology
CartoSound Communication
Intracardiac Echocardiography (ICE) Imaging
syngo fourSight TEE View
syngo Mitral Valve Assessment (MVA)
syngo fourSinght 4D imaging
Contrast Agent Imaging
syngo Auto follicle (X700 only)
eSie Touch (X700 only) |

---------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 9 of 28

11

510(k) Number (if known): K141846

Device Name:

CW5 Continuous Wave Doppler Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 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
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal				P
	Abdominal				P
	Intra-operative
(Note 6)				P
	Intra-operative
(Neuro)
	Laparoscopic
	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	Cardiac Adult				P
	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

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 10 of 28

12

510(k) Number (if known): K141846

| Device Name: | AcuNav 8F 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
( Track1
Only)	Specific
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
Fetal
Imaging
& Other	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
	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	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared

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 (X700 only)
		Note 22	eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 11 of 28

13

510(k) Number (if known): K141846

| AcuNav 10F Intracardiac Transducer for use with:
Device Name:

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
(Tracks1& 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
	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 Advanced SieClear Note 4
3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 12 of 28

14

V5Ms TEE Transducer for use with:

510(k) Number (if known): K141846

Device Name:

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 Power Specific Color Combined Other B M PWD CWD ( Track 1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (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) P P P P P P BMDC Cardiac Adult Note 2,7,9,14,17,18,19 Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal P P P P P P BMDC Note 2,7,9,14,17,18,19 (Cardiac) Intra-cardiac Other (Specify) Peripheral Perinheral vessel 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
Axius Edge Assisted Eiection Fraction Note 8
Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging

Note 11 syngo Arterial Health Package (AHP)
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

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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k) K141846

Page 13 of 28

15

510(k) Number (if known): K141846

Device Name:

4V1c Phased Sector Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound System

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	P	P		P	P	BMDC	Note 2,9
	Abdominal	P	P	P		P	P	BMDC	Note 2,9
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic	P	P	P	P	P	P	BMDC	Note 2,9
	Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,9
	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 2,7,8,9, 13, 14
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

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
Note 9	Clarify Vascular Enhancement Technology
Note 10	SieScape Panoramic Imaging

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

syngo Auto Left Heart (Auto LH) Technology Note 13

Note 14 syngo Velocity Vector Imaging Technology

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 (X700 only) Note 21

Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k) K141846

Page 14 of 28

16

510(k) Number (if known): K141846

C7F2 Curved Array Mechanical 3D/4D Transducer for use with: Device Name: ACUSON X700 Diagnostic Ultrasound Systems

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

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	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)
	Laparoscopic
Fetal	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

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo
Note 2	Dynamic TCE Technology	Note 12	syngo
Note 3	SieClear	Note 13	syngo
Note 4	Advanced SieClear	Note 14	syngo
Note 5	3-Scape 3D Imaging	Note 15	Carto
Note 6	For example: abdominal, vascular	Note 16	Intrac
Note 7	Stress Echo Imaging	Note 17	syngo
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo
Note 9	Clarify Vascular Enhancement Technology	Note 19	syngo
Note 10	SieScape Panoramic Imaging	Note 20	Cont
		Note 21	syngo
		Note 22	eSie

Arterial Health Package (AHP)
Auto OB Measurements
Auto Left Heart (Auto LH) Technology
Velocity Vector Imaging Technology
Sound Communication
ardiac Echocardiography (ICE) Imaging
fourSight TEE View
Mitral Valve Assessment (MVA)
fourSinght 4D imaging
ast Agent Imaging
Auto follicle (X700 only)
Sie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 15 of 28

17

510(k) Number (if known): K141846

| Device Name: | | EV9F4 Curved Array Mechanical 3D/4D 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
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(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 | P | BMDC | Note 2,3,4,5,9,10,19 | | |
| | Trans-vaginal | P | 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

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 fourSinght 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging
Note 21	syngo Auto follicle (X700 only)
Note 22	eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

510(k)_K141846

Page 16 of 28

18

510(k) Number (if known): K141846 SoundStar 10F Transducer for use with: Device Name: 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 Power Specific Color Combined Other B M PWD CWD ( Track 1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card ) Musculo-skel. (Convent.) Musculo-skel. (Superfic) P P Intra-vascular P P P P BMDC Note 2,8,9,13,14,15,16 Other (Specify) P P P P P P BMDC Cardiac Adult Note 2,8,9,13,14,15,16 P P P P P P Cardiac Cardiac Pediatric BMDC Note 2,8,9,13,14,15,16 Intra-vascular P P P P P P BMDC Note 2,8,9,13,14,15,16 (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac P P P P P P BMDC Note 2,8,9,13,14,15,16 Other (Specify) Peripheral Perinheral vessel 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 Advanced SieClear
Note 4 3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 17 of 28

19

510(k) Number (if known): K141846

| 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
(Track1
Only) | | Specific
(Tracks1& 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

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
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
syngo Velocity Vector Imaging Technology Note 14 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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 18 of 28

20

VF16-5 Transducer for use with:

510(k) Number (if known): K141846

Device Name:

| Device Name:
Intended Use:

Clinical Application		ACUSON X700 Diagnostic Ultrasound Systems
		Diagnostic imaging or fluid flow analysis of the human body as follows:
		Mode of Operation						Combined
(Specify)	Other
(Specify)
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	BMDC	Note 2,3,4,9,10,11,22
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
Fetal
Imaging
& Other	Laparoscopic
	Pediatric	N	N	N		N	N		Note 2,3,4,9,10,11
	SmallOrgan
(Note 1)	N	N	N		N	N		Note 2,3,4,9,10,11,22
	Neonatal Cephalic	N	N	N		N	N		Note 2,3,4,9,10,11
	Adult Cephalic	N	N	N		N	N		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		Note 2,3,4,9,10,11,22
	Musculo-skel.
(Superfic)	N	N	N		N	N		Note 2,3,4,9,10,11,22
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	N		Note 2,3,4,9,10,11
	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 Advanced SieClear Note 4
3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 19 of 28

21

510(k) Number (if known): K141846

C6F2 Transducer for use with: Device Name: ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows: Intended Use:

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	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,6,9,10
	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

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo Arterial Health Package
Note 2	Dynamic TCE Technology	Note 12	syngo Auto OB Measurements
Note 3	SieClear	Note 13	syngo Auto Left Heart (Auto LH-
Note 4	Advanced SieClear	Note 14	syngo Velocity Vector Imaging
Note 5	3-Scape 3D Imaging	Note 15	CartoSound Communication
Note 6	For example: abdominal, vascular	Note 16	Intracardiac Echocardiography
Note 7	Stress Echo Imaging	Note 17	syngo fourSight TEE View
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo Mitral Valve Assessment
Note 9	Clarify Vascular Enhancement Technology	Note 19	syngo fourSinght 4D imaging
Note 10	SieScape Panoramic Imaging	Note 20	Contrast Agent Imaging
		Note 21	syngo Auto follicle (X700 only)
		Note 22	eSie Touch (X700 only)

AHP)

Lote 12 syngo Auto OB Measurements

Lote 13 sun00 Auto Left Heart (Auto LH) Tech

Technology Technology

Note 14
Syngo Velocity Vector Imaging Technology
Note 15
CartoSound Communication

ICE) Imaging

te 17 syngo fourSight TEE View

(MVA)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 20 of 28

22

510(k) Number (if known): K141846

Intended Use:

C8F3 Transducer for use with: Device Name:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 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
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	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
Vessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11	syngo Arterial Health Package
Note 2	Dynamic TCE Technology	Note 12	syngo Auto OB Measurements
Note 3	SieClear	Note 13	syngo Auto Left Heart (Auto L
Note 4	Advanced SieClear	Note 14	syngo Velocity Vector Imaging
Note 5	3-Scape 3D Imaging	Note 15	CartoSound Communication
Note 6	For example: abdominal, vascular	Note 16	Intracardiac Echocardiography
Note 7	Stress Echo Imaging	Note 17	syngo fourSight TEE View
Note 8	Axius Edge Assisted Ejection Fraction	Note 18	syngo Mitral Valve Assessment
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 (X700 only)
		Note 22	eSie Touch (X700 only)

(AHP)

lote 12 syngo Auto OB Measurements
lote 16 Auto Follicle (Auto IUI) Tracking

H) Technology Technology

Note 14 Syngo Velocity Vector Imaging Technic
Note 15 CartoSound Communication

(ICE) Imaqing

nt (MVA)

eSie Touch (X700 only

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 21 of 28

23

510(k) Number (if known): K141846

Device Name:

EV9F3 Transducer for use with:

Intended Use:

ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems 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	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,9,10
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,19
	Trans-vaginal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,19,21
	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

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 11
Note 2	Dynamic TCE Technology	Note 12
Note 3	SieClear	Note 13
Note 4	Advanced SieClear	Note 14
Note 5	3-Scape 3D Imaging	Note 15
Note 6	For example: abdominal, vascular	Note 16
Note 7	Stress Echo Imaging	Note 17
Note 8	Axius Edge Assisted Ejection Fraction	Note 18
Note 9	Clarify Vascular Enhancement Technology	Note 19
Note 10	SieScape Panoramic Imaging	Note 20
		Note 21
		Note 22

syngo Arterial Health Package (AHP)
syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology
syngo Velocity Vector İmaging Technology
CartoSound Communication
Intracardiac Echocardiography (ICE) Imaging

syngo fourSight TEE View

syngo Mitral Valve Assessment (MVA)
syngo fourSinght 4D imaging
Contrast Agent Imaging
syngo Auto follicle (X700 only)
eSie Touch (X700 only) Note 22

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 22 of 28

24

510(k) Number (if known): K141846

Device Name: Intended Use:

C8-5 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
( Track 1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative
(Note 6)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative
(Neuro)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
Imaging
& Other	SmallOrgan
(Note 1)
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
Other (Specify)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10

N = new indication; P = previously cleared

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

Note 2 Dynamic TCE Technology
Note 3 SieClear
Advanced SieClear Note 4 Note 5 3-Scape 3D Imaging
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 23 of 28

25

P8-4 Transducer for use with:

510(k) Number (if known): K141846

Device Name:

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 Specific Color Power Combined Other B PWD CWD M ( Track 1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal N N N N N BMDC Note 2,3,4,5,6,9,10 Abdominal N N N BMDC N N Note 2,3,4,5,6,9,10 Intra-operative N N N N N BMDC Note 2,3,4,5,6,9,10 (Note 6) Intra-operative N BMDC N N N N Note 2,3,4,5,6,9,10 (Neuro) Laparoscopic Fetal Pediatric N N N N N BMDC Note 2,3,4,5,6,9,10 Imaging SmallOrgan & Other (Note 1) Neonatal Cephalic N N N N N BMDC Note 2,3,4,5,6,9,10 Adult Cephalic N N N BMDC N N Note 2,3,4,5,6,9,10 Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card ) Musculo-skel. N N N N N BMDC Note 2,3,4,5,6,9,10 (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult BMDC Cardiac Cardiac Pediatric N N N N N Note 2,3,4,5,6,9,10

N = new indication; P = previously cleared

Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify)

Perinheral vessel

Other (Specify)

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

N

Note 2 Dynamic TCE Technology
Peripheral

Vessel

Note 3 SieClear Advanced SieClear Note 4
3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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)
N
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology

BMDC

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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

N

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 24 of 28

Note 2,3,4,5,6,9,10

26

510(k) Number (if known): K141846

Device Name: Intended Use:

MC9-4 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
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,21
	Abdominal
	Intra-operative
(Note 6)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Neonatal Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Trans-vaginal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12,21
	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

Note 1	For example: breast, testes, thyroid, penis, prostate, etc.	Note 1
Note 2	Dynamic TCE Technology	Note 1
Note 3	SieClear	Note 1
Note 4	Advanced SieClear	Note 1
Note 5	3-Scape 3D Imaging	Note 1
Note 6	For example: abdominal, vascular	Note 1
Note 7	Stress Echo Imaging	Note 1
Note 8	Axius Edge Assisted Ejection Fraction	Note 1
Note 9	Clarify Vascular Enhancement Technology	Note 1
Note 10	SieScape Panoramic Imaging	Note 2
		Note 2

syngo Arterial Health Package (AHP)
syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology

syngo Velocity Vector İmaging Technology
CartoSound Communication

Intracardiac Echocardiography (ICE) Imaging

syngo fourSight TEE View

8 syngo Mitral Valve Assessment (MVA)

syngo fourSinght 4D imaging
Contrast Agent Imaging

syngo Auto follicle (X700 only)

eSie Touch (X700 only) Note 22

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 25 of 28

27

CH5-2 Transducer for use with:

510(k) Number (if known): K141846

Device Name:

Device Name:			ACUSON X600 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
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10,12
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative
(Note 6)	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	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	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,9,10
	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
Advanced SieClear Note 4
3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_K141846

Page 26 of 28

28

C6-2 Transducer for use with:

510(k) Number (if known): K141846

Device Name:

| Device Name:
Intended Use:
Clinical Application | | ACUSON X600 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | |
|-------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------|------------|---|--|---|---|------|------------------------|
| | | | | | | | | | |
| | | Ophthalmic | Ophthalmic | | | | | | |
| | Fetal | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10,12 |
| | Abdominal | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | Intra-operative
(Note 6) | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | 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 | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | 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
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
syngo Velocity Vector Imaging Technology Note 14
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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_K141846

Page 27 of 28

29

510(k) Number (if known): K141846

| Device Name: | | Soundstar eco 8F 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
(Tracks1& 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.
--------	-------------------------------------------------------------

Note 2 Dynamic TCE Technology
Note 3 SieClear
Advanced SieClear Note 4 3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
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
syngo Velocity Vector Imaging Technology Note 14 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
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846

Page 28 of 28

30

510(k) Summary Prepared June 25, 2014

| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility | SIEMENS LTD SEOUL
2nd -3rd floor, 143, Sunhwan-ro,
Jungwon-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea |
| Contact Person: | Shelly Pearce
Telephone: (650) 694-5988
Fax: (650) 694-5580 |
| Device Name: | ACUSON X700™ Ultrasound System
ACUSON X600™ Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |
| Regulatory Class: | II |

Regulatory Class:	II
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™ and X600™ Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X700 ultrasound system (K123001), ACUSON S2000 ultrasound system (K112596), X300 ultrasound system (K121699), S1000/S2000/S3000 ultrasound systems (K132804)

B. Device Description:

The Siemens ACUSON X700™ and X600™ are multi-purpose mobile, software controlled, diagnostic ultrasound systems 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, 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

31

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 reqarding 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 Siemens ACUSON X700™ and X600™ Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X700 ultrasound system (K123001), ACUSON S2000 ultrasound system (K112596), X300 ultrasound system (K121699), S1000/S2000/S3000 ultrasound systems (K132804). All systems transmit ultrasonic enerqy into patients, and 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.

| Feature /
Characteristic | Predicate
Device
ACUSON
X700
(K123001) | Predicate
Device
ACUSON
S2000
(K112596) | Predicate
Device
ACUSON
X300
(K121699) | Predicate
Device
ACUSON
S1000/S2000/3
000
(K132804) | Submission
Device
ACUSON
X600TM | Submission
Device
ACUSON
X700TM | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------|-----------------------------------------|
| Indications for Use: | | | | | | | |
| ■ Fetal Echo | √ | √ | √ | √ | √ | √ | |
| ■ Abdominal | √ | √ | √ | √ | √ | √ | |
| ■ Renal | √ | √ | √ | √ | √ | √ | |
| ■ Cerebrovascular | √ | √ | √ | √ | √ | √ | |
| ■ Orthopedics | √ | √ | √ | √ | √ | √ | |
| ■ Small Organ | √ | √ | √ | √ | √ | √ | |
| Feature /
Characteristic | Predicate
Device
ACUSON
X700
(K123001) | Predicate
Device
ACUSON
S2000
(K112596) | Predicate
Device
ACUSON
X300
(K121699) | Predicate
Device
ACUSON
S1000/S2000/3
000
(K132804) | Submission
Device
ACUSON
X600TM | Submission
Device
ACUSON
X700TM | |
| ■ Pediatric | √ | √ | √ | √ | √ | √ | |
| ■ Adult Cephalic | √ | √ | √ | √ | √ | √ | |
| ■ Cardiac (Adult) | √ | √ | √ | √ | √ | √ | |
| ■ Intracardiac | √ | √ | √ | √ | √ | √ | |
| ■ Trans-esophageal | √ | √ | √ | √ | √ | √ | |
| ■ Transrectal | √ | √ | √ | √ | √ | √ | |
| ■ Urolology | √ | √ | √ | √ | √ | √ | |
| ■ Transvaginal | √ | √ | √ | √ | √ | √ | |
| ■ Peripheral vessel | √ | √ | √ | √ | √ | √ | |
| ■ Musculo-skeletal
(conventional) | √ | √ | √ | √ | √ | √ | |
| ■ Musculo-skeletal
(superficial) | √ | √ | √ | √ | √ | √ | |
| ■ Emergency
Medicine | √ | √ | √ | √ | √ | √ | |
| Center Frequencies
Supported: | | | | | | | |
| ■ 2.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 2.5 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 3.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 3.5 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 4.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 5.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 5.5 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 6.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 6.5 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 7.5 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 8.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 9.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 10.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 11.0 MHz | √ | √ | √ | √ | √ | √ | |
| ■ 12.0 MHz | - | - | - | - | - | √ | |
| ■ 13.0 MHz | - | - | - | - | - | √ | |
| Modes:
■ | | | | | | | |
| B | √ | √ | √ | √ | √ | √ | |
| ■ M | √ | √ | √ | √ | √ | √ | |
| ■ PWD (Pulsed
Wave Doppler) | √ | √ | √ | √ | √ | √ | |
| ■ CWD
(Continuous Wave
Doppler) | √ | √ | √ | √ | √ | √ | |
| ■ SCW (Steerable
CW) | √ | √ | √ | √ | √ | √ | |
| ■ CD (Color
Doppler) | √ | √ | √ | √ | √ | √ | |
| ■ Amplitude
Doppler
(Power Doppler) | √ | √ | √ | √ | √ | √ | |
| Feature /
Characteristic | Predicate
Device
ACUSON
X700
(K123001) | Predicate
Device
ACUSON
S2000
(K112596) | Predicate
Device
ACUSON
X300
(K121699) | Predicate
Device
ACUSON
S1000/S2000/3
000
(K132804) | Submission
Device
ACUSON
X600TM | Submission
Device
ACUSON
X700TM | |
| ■ | Directional
Power Doppler | √ | √ | √ | √ | √ | √ |
| ■ | Combined (BM,
BC, BCM, BCD) | √ | √ | √ | √ | √ | √ |
| ■ | THI (Tissue
Harmonic Imaging) | √ | √ | √ | √ | √ | √ |
| ■ | AMM
(Anatomical M-
mode) | √ | √ | √ | √ | √ | √ |
| ■ | Doppler Tissue
Image (Color, PW) | √ | √ | √ | √ | √ | √ |
| ■ | M-THI | √ | √ | √ | √ | √ | √ |
| | Features: | | | | | | |
| ■ | Multi-View
Spatial
Compounding
(SieClear) | √ | √ | √ | √ | √ | √ |
| ■ | Advanced
SieClear | √ | √ | - | √ | √ | √ |
| ■ | DTCE (Dynamic
Tissue Contrast
Enhancement) | √ | √ | √ | √ | √ | √ |
| ■ | Tissue Grayscale
Optimization
(TGO) | √ | √ | √ | √ | √ | √ |
| ■ | Dual-Beam
Processing | √ | √ | √ | √ | √ | √ |
| ■ | Quad-Beam
Processing | √ | √ | √ | √ | √ | √ |
| ■ | Clip Capture | √ | √ | √ | √ | √ | √ |
| ■ | 3D Imaging (3-
Scape) | √ | √ | √ | √ | √ | √ |
| ■ | 3D
Measurements | √ | √ | √ | √ | √ | √ |
| ■ | 4D Basic
Imaging (fourSight
4D) | √ | √ | √ | √ | √ | √ |
| ■ | Panoramic 2D
Imaging
(SieScape) | √ | √ | √ | √ | √ | √ |
| ■ | Syngo Auto OB | √ | √ | √ | √ | √ | √ |
| ■ | Syngo Auto
Follicle | √ | - | - | - | - | √ |
| ■ | Cardiac Imaging
physiological
signal display
multiplane TEE
fourSight TEE
Imaging | √ | √ | √ | √ | √ | √ |
| ■ | Stress Echo | √ | √ | √ | √ | √ | √ |
| ■ | Vascular
Enhancement
(Clarify VE) | √ | √ | √ | √ | √ | √ |
| | Feature /
Characteristic | Predicate
Device
ACUSON
X700
(K123001) | Predicate
Device
ACUSON
S2000
(K112596) | Predicate
Device
ACUSON
X300
(K121699) | Predicate
Device
ACUSON
S1000/S2000/3
000
(K132804) | Submission
Device
ACUSON
X600™ | Submission
Device
ACUSON
X700™ |
| ■ | Syngo VVI
(Velocity Vector
Image) | √ | √ | √ | √ | √ | √ |
| ■ | Auto Left Heart | √ | √ | √ | √ | √ | √ |
| ■ | Axius EF | √ | √ | √ | √ | √ | √ |
| ■ | Syngo AHP | √ | √ | √ | √ | √ | √ |
| ■ | Contrast Agent
Image | √ | √ | √ | √ | √ | √ |
| ■ | DIMAQ | √ | √ | √ | √ | √ | √ |
| ■ | Multiple
Frequency
Imaging(MultiHertz
) | √ | √ | √ | √ | √ | √ |
| ■ | syngo Mitral
Valve
Assessments
(MVA) | √ | √ | √ | √ | √ | √ |
| ■ | Intracardiac
Echocardiography
(ICE) Imaging | √ | √ | √ | √ | √ | √ |
| ■ | Digital
Architecture | √ | √ | √ | √ | √ | √ |
| ■ | Panoramic 2D
Imaging
(Siescape) | √ | √ | √ | √ | √ | √ |
| ■ | Fully integrated
DICOM | √ | √ | √ | √ | √ | √ |
| ■ | CARTOSOUND
™ Communication | √ | - | √ | √ | - | √ |
| ■ | Monitor: 20" wide
(FPD) | √ | √ (19" FPD) | (17" FPD) | √ (21" FPD) | √ | √ |
| ■ | Wireless | √ | √ | √ | √ | √ | √ |
| ■ | eSie Touch | - | √ | - | √ | - | √ |
| | # Channels | 128 | 192 | 128 | 192 | 128 | 128 |
| | Output Display
Standard
(Track 3) | √ | √ | √ | √ | √ | √ |
| | Patient Contact
Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 |
| | UL60601-1 Certified | √ | √ | √ | √ | √ | √ |

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

32

33

34

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:

트 UL 60601-1, Safety Requirements for Medical Equipment
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ■

35

AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
트 93/42/EEC Medical Devices Directive
트 Safety and EMC Requirements for Medical Equipment
- . EN/IEC 60601-1
- EN/IEC 60601-1-1 .
- . EN/IEC 60601-1-2
- I EN/IEC 62304
- I EN/IEC 62366
- EN/IEC 60601-2-18
- EN/IEC 60601-2-25
ISO 10993-1 Biocompatibility 트

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 ACUSON X700 and X600 use 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 quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation 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 ACUSON X700 and X600 are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The ACUSON X700 and X600 are verified and validated according to the company's design control process.