Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on standard ultrasound imaging modes and measurement packages.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound imaging" and "clinical diagnosis purposes". It does not mention any therapeutic function.

Diagnostic

Co-authored by a large language model and a biomedical expert.

Yes.

The "Device Description" section explicitly states, "The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems." The "Intended Use / Indications for Use" section also notes that the system provides "calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states "The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems". This indicates the device includes hardware components (the ultrasound system itself) in addition to the software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states that this is an ultrasound imaging system. It uses sound waves to create images of internal anatomical structures.
Intended Use: The intended uses listed are all related to imaging and visualization of anatomical structures within the body, as well as measuring these structures. While the measurements and calculations can be used adjunctively with other medical data for diagnosis, the device itself is not analyzing biological specimens.
Device Description: The description focuses on the technical aspects of the ultrasound system and its imaging modes.
Lack of Specimen Handling: There is no mention of the device interacting with or analyzing biological specimens.

In summary, this device is a diagnostic imaging system that operates in vivo (within the living body), not in vitro (in glass or outside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

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

IYN, IYO, ITX, OBJ

Device Description

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Small Parts (i.e. breast, testes, thyroid, penis, prostate), Intraoperative, Transcranial, OB/GYN, Transesophageal, Transrectal, Transvaginal, Intra-cardiac, Intra-luminal (great vessel)

Indicated Patient Age Range

Adult and Pediatric

Intended User / Care Setting

Clinician, Physician / Not specified; likely clinical setting like a hospital or clinic.

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 were performed for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic and mechanical safety. The device conforms to applicable medical device safety standards. 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.

K140959

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.

K123001

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 U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble ribbons or waves. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

October 23, 2014

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

Re: K142876

Trade/Device Name: Acuson S1000/ S2000/ S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: September 30, 2014 Received: October 1, 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 S1000, S2000, S3000 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

12L4	CW2 Probe	CW5 Probe
EC9-4 Curved Array	MC9-4 Curved Array	9L4 Linear Array
14L5 Multi-D Array	4P1 Phased Array	6C2 Curved Array
4C1 Curved Array	6C1HD Curved Array	8C3HD Curved Array
4V1 Phased Array	10V4 Phased Array	14L5 SP Linear Array
9EVF4 Curved Array	V5Ms Multiplane TEE	18L6 HD Linear Array
8V3 Phased Array	4V1c Phased Array	6L3
EV8C4	V7M TEE	7CF2 Curved array mechanical 3D
7CF1 Curved array mechanical 3D		AcuNav 8F Ultrasound Catheter
AcuNav 10F Ultrasound Catheter

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,

Sm.m.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

1.3 INDICATIONS FOR USE

510(k) Number (if known): K142876

Device Name: S1000, S2000, S3000 Diagnostic Ultrasound Systems

Indications for Use:

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

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

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

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

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known): Device Name: Intended Use:

ACUSON S1000, S2000, S3000 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic	P	P	P	P	P	P	P	BMDC
Fetal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13, 16, 18
Intraoperative
(Note 9)	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14
Intraoperative
Neurological	P	P	P	P	P	P	P	BMDC
Pediatric	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Small Organ
(Note 1)	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 16, 18
Neonatal Cephalic	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac	P	P	P	P	P	P	P	BMDC	Note
2,3,4,5,6,7,8,10,15
Trans-esophageal	P	P	P	P	P	P	P	BMDC	Note 4
Transrectal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Transvaginal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Transurethral	P	P	P	P	P	P	P	BMDC
Intravascular	P	P	P	P	P	P	P	BMDC
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,10,
11,14,15
Laparoscopic	P	P	P	P	P	P	P	BMDC
Musculo-skeletal
Conventional	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 18
Musculo-skeletal
Superficial	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 18
Other (specify)	P	P	P	P	P	P	P	BMDC	Note 3,4,6, 10

N = new indication; P = previously cleared by FDA K140959 Additional Commnets:

P. Tautenhahn, S. Reith, S. Schmitt

Note 1 i.e. breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging Note 18 VTI

Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology

Note 2 Ensemble tissue harmonic imaging

Note 13 STIC
Note 15 AHP
Note 17 eSie Fusion

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4

Concurrence of Center for Devices and Radiological Health (CDRH)

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):	_________________________
Device Name:	12L4 Transducer for use with ACUSON S1000, S2000 and
S3000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as
follows:
	Mode of Operation

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Small Organ
(Note 1)	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5, 7,8,10,
11, 14
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.
SieClear multi-view spatial compounding Note 3
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology compounding/DTCE

Note 14 eSie™ Touch elasticity imaging

Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial

Custom Tissue Imaging /FTI Note 16

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510 (k) Number (if known): Device Name:

CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

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

Note 9 For example: vascular, abdominal

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510 (k) Number (if known): Device Name:

CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological					P
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal

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510 (k) Number (if
known):
Device Name:

EC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound System

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10,
11
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal		P	P	P		P	P	BMDC	Note 2,3,4,5, 6, 7,8,10,
11,14
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 1 i.e .: breast, testes, thyroid, penis, prostate, etc.

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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510 (k) Number (if known): Device Name:

MC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,,7,8,10,
11, |
| Intraoperative
Note 9 | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Note 1) | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11,14 |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,
11,14 |
| Transvaginal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging Note 9 Abdomen and Vascular

Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement

technology

Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI

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510 (k) Number (if known):
Device Name:

9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Abdominal
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Small Organ
(Note 1)	P	P	P	P		P	P	BMDC	Note
2,3,4,5,6,7,8,10,
11,14, 16, 18
Neonatal Cephalic	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Adult Cephalic	P	P	P	P		P	P	BMDC
Cardiac	P	P	P	P		P	P	BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P	BMDC	Note 2,3,4,5,6,
7,8,10, 11, 14,15
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P		P	P	BMDC	Note
2,3,4,5,6,7,8,10, 11,
14
Musculo-skeletal
Superficial	P	P	P	P		P	P	BMDC	Note
2,3,4,5,6,7,8,10, 11,
14
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial compounding
Note 15 AHP
Note 18 VTI (Virtual Touch Imaging)
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging

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10

510 (k) Number (if known):

Device Name:

14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,6,
7,8,10, 11, 14
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14
Musculo-skeletal
Superficial
Other (specify)

N = new indication: P = previously cleared by FDA K140959 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 9 Abdomen and Vascular

technology

Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging

te 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement Note 10

Note 14. eSio™ Touch elasticity imaging (ETI)

Note 14 eSie™ Touch elasticity imaging / FTI Note 18 Virtual Touch Imaging

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11

510 (k) Number (if known):

Device Name:

4P1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 10Clarify VE vascular enhancement technology

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12

510 (k) Number (if known):
Device Name:

6C2 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16, 17
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 11 Advanced Sieclear spatial compounding

Note 4 Tissue Equalization Technology

Note 7 B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging
Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 17 eSie Fusion

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13

510 (k) Number (if known):
Device Name:

4C1 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Abdominal	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8, 10,
11, 14, 16, 17, 18
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P	BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 11 Advanced Sieclear spatial

Note 16 Custom Tissue Imaging Note 18 VTI

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14

510 (k) Number (if known):

6C1HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems

Intended Use:

Device Name:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Abdominal	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,
10, 11, 14, 16, 17,
18
Intraoperative
Note 9
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P	BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 9 Abdomen and Vascular

Note 11 Advanced Sieclear spatial

Note 16Custom Tissue Imaging Note 18 VTI

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15

510 (k) Number (if known):
Device Name:

8C3HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11, 14, 16 |
| Intraoperative
Note 9 | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 |
| Small Organ | | P | P | P | | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
11 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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16

510 (k) Number (if known):
Device Name:

4V1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
14, 16, 17
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K40959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial

Note 7 B&W SieScape panoramic imaging Note 10Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging

Note 17 eSie Fusion

compounding

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17

510 (k) Number (if known): Device Name:

10V4 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC	Note 3,4
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

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18

510 (k) Number (if known): Device Name:

14L5 SP Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Indications For Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 9)		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note2,3,4,5,6
,7,8,10, 11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 For example: vascular, abdominal
technology

Note 11 Advanced Sieclear spatial compounding Note 15AHP

te 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement

Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging

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19

510 (k) Number (if known):

7CF2 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

Device Name:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10,
11,13
Abdominal		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10, 11,
13
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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20

510 (k) Number (if known):

Device Name:

7CF1 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color Velocity Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,13
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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21

510 (k) Number (if known):
Device Name:

9EVF4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	A	Mode of Operation
		B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,
10,11, 13
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,
10,11
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,
10,11
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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22

510 (k) Number (if known): Device Name:

V5Ms Multiplane TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P	BMDC	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 140959

Additional Comments:

Note 4 Tissue Equalization Technology

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23

510 (k) Number (if known):

18L6 HD Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

Device Name:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Other (specify)

N = new indication; P = previously cleared by FDA K081148, K090334, K093812, K111674, K121138

Additional Comments:

Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 15AHP

Note 4 Tissue Equalization Technology

Note 7 B&W SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging Note 16 Custom Tissue Imaging/FTI

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24

510 (k) Number (if known):

Device Name:

8V3 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC	Note 3,4,6
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
Neonatal Cardiac		P	P	P	P	P	P	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K# 140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

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510 (k) Number (if known):

Device Name:

4V1c Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Intraoperative | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Intraoperative
Neurological | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10
15 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10
15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | P | P | P | P | P | P | P | | BMDC | Note 2 3 4 5 7 8 10 |

N = new indication; P = previously cleared by FDA K#'s 140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology

Note 15 AHP

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510 (k) Number (if known):
Device Name:

6L3 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11
Abdominal
Intraoperative
Note 9	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11
Intraoperative
Neurological
Pediatric
Small Organ	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
1
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11 15
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11
Musculo-skeletal
Superficial	P	P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10,
11
Other (specify)

N = new indication; P = previously cleared by FDA K#'s140959 Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 3 SieClear multi-view spatial compounding

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 10Clarify VE vascular enhancement technology Note 15 AHP

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510 (k) Number (if known):
Device Name:

EV8C4 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Abdominal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 6 7 8
10
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K#'s 140959 Additional Comments:

Note 2: Ensemble tissue homogenate size is ~200 µL.

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging

Note 8 Power Siescape panoramic imaging
Note 10Clarify VE, vascular enhancement technique

Note 10Clarify VE vascular enhancement technology

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510 (k) Number (if known): Device Name:

V7M TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

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

Clinical Application	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Combined (Specify) *	Harmonic Imaging	Other (Specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	P	Note 4
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	P	Note 4
Small Organ
(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	Note 4
Trans-esophageal	P	P	P	P	P	P	P	P	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications #K140959 Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE

Note 2 Ensemble tissue harmonic imaging Note 4 Tissue Equalization Technology Note 10Clarify VE vascular enhancement technology

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29

patients.

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):
Device Name:	AcuNav 8F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:	The AcuNav™ Ultrasound Catheter is 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

Mode of Operation Clinical Application Color Power Color Combined Other: Doppler (Amplitude) Velocity (Specify) * Harmonic B PWD CWD A M Doppler Imaging Imaging Ophthalmic Fetal Abdominal Intraoperative (Vascular) Intraoperative (Neurological) Pediatric P P P P P P P Small Organ (Specify)** Neonatal Cephalic Adult Cephalic Cardiac P P P P P P P Trans-esophageal Transrectal Transvaginal Transurethral Intra-Luminal P P P P P P P Peripheral Vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (Intra-Cardiac) P P P P P P P

P=previously cleared by the FDA K140959

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, Doppler, B+CWD+Power Doppler

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510 (k) Number (if known): Device Name:

AcuNav 10F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems

Intended Use:

The AcuNav™ Ultrasound Catheter is 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.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Power
(Amplitude)
Doppler	Color
Velocity
Imaging	Combined
(Specify) *	Other:
Harmonic
Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative
(Vascular)
Intraoperative
(Neurological)
Pediatric	P	P	P	P	P	P	P	P
Small Organ
(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal	P	P	P	P	P	P	P	P
Peripheral Vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Intra-Cardiac)	P	P	P	P	P	P	P	P

P=Previously cleared by the FDA K140959

Additional Comments:

*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

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31

510(k) Summary

October 15, 2014

| 1. Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Burke
Telephone:
(425) 295-8665
Fax:
(425) 391-9161 |
| 2. Device Name: | Acuson S1000, S2000, S3000™ Diagnostic Ultrasound Systems |
| Common Name: | Diagnostic Ultrasound System |
| Classification:
Requlatory Class:
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 Ultrasound Catheter FR # 870.1200 Product Code OBJ

3. Legally Marketed Predicate Devices

The modified Acuson S1000, S3000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:

System	510(k)
S1000	K140959
S2000	K140959
S3000	K140959

The biopsy needle guide for use with the 12L4 transducer is substantially equivalent to the biopsy guide currently cleared for use with the VF12-4 transducer on the company's X700 Ultrasound System (K123001).

4. Device Description:

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

32

5. Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

6. Summary of Technological Characteristics

The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as the company's own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems (K140959) with reqard to both intended use and technological characteristics. Both the subject ultrasound systems and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

| Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson
S1000/S2000/S3000
K# 140959 | |
|-----------------------------------|-------------------------------------------------|------------------------------------------------|------------------------------------------|
| Indications for Use: | | | |
| ■ Fetal | √ | √ | |
| ■ Abdominal | √ | √ | |
| ■ Intraoperative | √ | √ | |
| ■ Intraoperative neurological | -- | -- | |
| ■ Pediatric | √ | √ | |
| ■ Small Organ | √ | √ | |
| ■ Neonatal cephalic | √ | √ | |
| ■ Adult Cephalic | √ | √ | |
| | Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson
S1000/S2000/S3000
K# 140959 |
| ■ | Cardiac | √ | √ |
| ■ | Trans-esophageal | √ | √ |
| ■ | Transrectal | √ | √ |
| ■ | Transvaginal | √ | √ |
| ■ | Peripheral vessel | √ | √ |
| ■ | Laparoscopic | - | - |
| ■ | Musculo-skeletal (conventional) | - | - |
| ■ | Musculo-skeletal (superficial) | √ | √ |
| | Center Frequencies Supported: | | |
| ■ | 2.0 MHz | √ | √ |
| ■ | 3.0 MHz | √ | √ |
| ■ | 3.2 MHz | √ | √ |
| ■ | 3.3 MHz | √ | √ |
| ■ | 4.2 MHz | √ | √ |
| ■ | 4.4 MHz | √ | √ |
| ■ | 4.8 MHz | √ | √ |
| ■ | 5.0 MHz | √ | √ |
| ■ | 5.2 MHz | √ | √ |
| ■ | 6.0 MHz | √ | √ |
| ■ | 6.5 MHz | √ | √ |
| ■ | 6.9 MHz | √ | √ |
| ■ | 9.5 MHz | √ | √ |
| ■ | 10.0 MHz | √ | √ |
| | Modes: | | |
| ■ | B | √ | √ |
| ■ | Parallel processing in B mode | √ | √ |
| ■ | M | √ | √ |
| ■ | PWD (Pulsed Wave Doppler) | √ | √ |
| ■ | CWD (Continuous Wave
Doppler) | √ | √ |
| ■ | D (Color Doppler) | √ | √ |
| ■ | Amplitude Doppler | √ | √ |
| ■ | Combined (BMDC) | √ | √ |
| | Features: | | |
| | Quad processing in color | √ | √ |
| ■ | Native™ tissue harmonic
imaging | √ | √ |
| ■ | SieScape™ panoramic
imaging | √ | √ |
| ■ | Color SieScape™ panoramic
imaging | √ | √ |
| ■ | 3-Scape™ real-time 3D
imaging | √ | √ |
| ■ | fourSight™ 4D transducer
technology | √ | √ |
| | Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson
S1000/S2000/S3000
K# 140959 |
| ■ | Cardiac Imaging
physiological signal display | √ | √ |
| ■ | syngo ® Auto OB
measurements | √ | √ |
| ■ | Advanced SieClear™ spatial
compounding | √ | √ |
| ■ | STIC (Fetal Heart Imaging) | √ | √ |
| ■ | Amnioscopic rendering | √ | √ |
| ■ | Cadence contrast agent
imaging | √ | √ |
| ■ | Clarify™ vascular
enhancement technology | √ | √ |
| ■ | eSie™ Touch elasticity imaging | √ | √ |
| ■ | syngo ® Auto Left heart | √ | √ |
| ■ | syngo ® Velocity Vector
Imaging | √ | √ |
| ■ | Semi Auto-segmentation (eSie
Calc) | √ | √ |
| ■ | Custom Tissue Imaging /
Speed of Sound | √ | √ |
| ■ | AHP | √ | √ |
| ■ | eSie Fusion (S3000 only) | √ | √ |
| ■ | VTI (S2000 & S3000 only) | √ | √ |
| | Wireless | √ | √ |
| | Monitor: 21" FPD | √ | √ |
| Output Display Standard (Track 3) | | √ | √ |
| Patient Contact Materials | | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| UL 60601-1 Certified | | √ | √ |
| | Indications for Use | √ | √ |

33

34

The characteristics of the biopsy needle guide for use with the 12L4 transducer in this submission are unchanged from the biopsy guide currently cleared for use with the VF12-4 transducer on the company's X700 Ultrasound System (K123001).

| Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson X700
K# 123001 |
|----------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------|
| Plastic reusable snap-on
needle guide adapter with
disposable needle quide | √ for use with 12L4
transducer | v for use with VF12-4
transducer |

7. 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

35

been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

UL 60601-1, Safety Requirements for Medical Equipment I
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
트 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
트 93/42/EEC Medical Devices Directive
I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- EN/IEC 60601-1-2 o
ISO 10993-1 Biocompatibility

Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.

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

Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical data is not required.

9. 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 Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to 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 $1000, $2000 and S3000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.