Predicate Devices

Not Found

Reference Devices

K063085, K072786, K081148, K082142, K090334, K063803, K080334, K052410, K051139, K032114, K022567, K002807, K973767, K041319, K992631, K033650, K042593, K071234.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, nor does it describe any training or test sets which are typical for AI/ML-based devices. The focus is on standard ultrasound functionalities and safety standards.

Therapeutic

No
The intended use and indications for use clearly state that the device is an "ultrasound imaging system" intended for "clinical diagnosis purposes" and for "measuring anatomical structures." It does not mention any therapeutic capabilities or functions.

Diagnostic

Yes

The document explicitly states that the system's calculation packages "provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Additionally, the "Device Description" section lists "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards" as a standard the device meets, directly implying its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device is described as an "ultrasound imaging system" and references multiple hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.), indicating it includes hardware components beyond just 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The S2000™ is an ultrasound imaging system. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
Intended Use: The intended use clearly describes imaging applications and measurements of anatomical structures within the body.
Device Description: The safety standards listed are for medical equipment used on patients, not for laboratory diagnostic devices.
Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.

While the system provides information that can be used adjunctively for clinical diagnosis, the primary function and method of operation are based on in vivo ultrasound imaging, not in vitro testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures (fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac) and calculation packages that provide information 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".

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

90-IYN, 90-IYO, 90-ITX

Device Description

The Acuson S2000™ has been designed to meet the following product safety standards:

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
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
93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment
EN/IEC 60601-1
EN/IEC 60601-1-1
EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power
ISO 10993-1 Biocompatibility

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative (vascular, abdominal, neurological), Pediatric, Small Parts (e.g., breast, testes, thyroid, penis, prostate), Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal (conventional, superficial), Peripheral Vessel, Trans-esophageal, Transrectal, Transvaginal, Intra-Luminal, Intra-Cardiac.

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, Adult

Intended User / Care Setting

Physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

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.

The Acuson S2000™ Ultrasound System is substantially equivalent to the Acuson Antares Ultrasound System.

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.

K063085, K072786, K081148, K082142, K090334, K063803, K080334, K052410, K051139, K032114, K022567, K002807, K973767, K041319, K992631, K033650, K042593, K071234.

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

K093812

Siemens Medical Solutions, Inc. Ultrasound Division

S2000 Ultrasound System 510(k) Submission

510(k) Summary Prepared December 28, 2009

| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | MAR - 3 2010 | |
|------------------|------------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact Person: | Shelly Pearce
Telephone: (650) 694-5988
Fax: (650) 694-5580 | | |
| Submission Date: | December 1, 2009 | | |
| Device Name: | Acuson S2000™ Diagnostic Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System | | |

Classification:

Regulatory Class: ll Review Category: Tier II Classification Panel: Radiology

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

A. Legally Marketed Predicate Devices

The Acuson S2000™ Ultrasound System is substantially equivalent to the Acuson Antares Ultrasound System.

B. Device Description:

The Acuson S2000™ has been designed to meet the following product safety standards:

l UL 60601-1, Safety Requirements for Medical Equipment
l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
li 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
t 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment 트
- . EN/IEC 60601-1
- . EN/IEC 60601-1-1
- I EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power 트
ISO 10993-1 Biocompatibility l

1

C. Intended Use

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures (fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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".

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

MAR - 3 2010

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

Re: K093812

Trade/Device Name: ACUSON S2000™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 8, 2010 Received: February 16, 2010

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the ACUSON S2000™ Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

CW2 CW5 EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 14L5BV Multi-D Array 4P1 Phased Array 6C2 Curved Array

4C1 Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 17L5HDS Linear Array

3

18L6 HD Linear Array	EV8C4
8V3 Phased Array	V7M TEE
4V1c Phased Array	AcuNav 8F Ultrasound Catheter
6L3	AcuNav 10F Ultrasound Catheter

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely yours,

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

4

1.3 Indications for Use

A. 510(k) Number (if known):

Device Name: S2000™Diagnostic Ultrasound System

Indications for Use:

The S2000™ 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 reaarding 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".

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Olvision of Radiolor

610K Kc93812

5

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

ACUSON S2000 Ultrasound System

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

Clinical Application	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, 16
Intraoperative
(Note 9)		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	BMDC	Note 2,3,4,5,7,8,10,
11, 14
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 2,3,4,5,7,8,10,
11,14, 16
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac		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	BMDC
Transrectal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Transvaginal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11
Transurethral
Intravascular
Peripheral vessel		P	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	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,
11,14
Other (specify)
Neonatal Cardiac		P	P	P	P	P	P	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K063085, K072786, K081148, K082142, K090334

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

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
STIC Note 13
Note 14 eSie™ Touch elasticity imaging / FTI

Note 15 AHP
Note 16 Custom Tissue Imaging

(Division Sign-Off)

(Division Aign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sately

510K K093812

6

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10 Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: CW2 Probe for use with ACUSON S2000 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 K# 063803, K072786, K081148, K090334

Additional Comments:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

A-A

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

7

510 (k) Number (if known):

CW5 Probe for use with ACUSON S2000

Device Name: 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 K# 063803, K072786, K081148, K080334

Additional Comments:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice: Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

D. A. D

(Division Sign-Of Division of Radiological D Vitro Diagnostic Device Evaluation and Safety Office of In

510K

8

510 (k) Number (if known):

Device Name: Intended Use:

EC9-4 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	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 Abdominal
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
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 K# 063803, K072786, K081148, K080334

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic 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

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (ODE) / T

9

510 (k) Number (if known):

9L4 Linear Array Transducer for use with ACUSON S2000

Device Name: 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
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11,14,
16
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
Adult Cephalic
Cardiac		P	P	P		P	P	BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note 2,3,4,5,6, 7,8,10, 11,
14,15
Laparoscopic
Musculo-skeletal
Conventional		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	BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Other (snecify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
Note 15 AHP
Note 16 Custom Tissue Imaging

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OIL i

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510 (k) Number (if known):

Device Name: Intended Use: 14L5 Multi-D Array Transducer for use with ACUSON S2000 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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| 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 K# 063085, K072786, K081148, K090334

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Advanced Sieclear spatial compounding Note 11
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Disonostic Davice Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice-Evaluation (ODE) Office T

11

510 (k) Number (if known):

Device Name: Intended Use:

14L5BV Multi-D Array Transducer for use with ACUSON S2000 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
Abdominal
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
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 081148

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

(Division Sign-Off Division of Radiological De Office of In Vitro Diagnostic Device Evaluation

510K. K093812

12

510 (k) Number (if known):

Device Name: Intended Use:

4P1 Phased Array Transducer for use with ACUSON S2000 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
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac		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 K# 063803, K072786, K081148, K090334 Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 6 Cadence contrast agent imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

13

.. .. ......

510 (k) Number (if known):

Device Name:

Intended Use:

6C2 Curved Array Transducer for use with ACUSON S2000 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
Abdominal	P	P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 14, 16
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric	P	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	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 K# 063085, K072786, K081148, K090334

Additional Comments:

Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

JAD

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (ODE) OF CO

14

510 (k) Number (if known):

Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000 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
Abdominal		P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,
10, 11, 14, 16
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ		P	P	P	P	P	P	BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K080334

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10
Advanced Sieclear spatial compounding Note 11
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

HAB

(Division Sign-Off Division of Radiological Device: Office of In

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (ODE) Of V /

15

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer for use with ACUSON S2000 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
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
14, 16
Intraoperative
Abdominal
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# 063085, K072786, K081148, K090334

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
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

D.A.R
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

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16

510 (k) Number (if known):

Device Name: Intended Use: 10V4 Phased Array Transducer for use with ACUSON S2000 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
Abdominal
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# 063085, K072786, K081148, K090334

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ()

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

17

510 (k) Number (if known):

Device Name:

i

Indications For Use:

14L5 SP Linear Array Transducer for use with ACUSON S2000 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
Intraoperative
Neurological		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11
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# 063085, K072786, K081148, K090334

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7 Note 8 Power SieScape panoramic imaging
For example: vascular, abdominal Note 9
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging / FTI Note 14

Note 15 AHP Note 16 Custom Tissue Imaging

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(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OBE) OFIJ ]

Prescription Use (Per 21 CFR 801.109)

.

18

510 (k) Number (if known):

Device Name: Intended Use:

7CF2 Curved array mechanical 3D transducer for use with ACUSON S2000 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,
11,13
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
Abdominal
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# 063803, K072786, K081148, K090334

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

.

(Division Sign-Off Division of Radiological Device ice Evaluation and Safety Office of In

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (F NEEDED) Concurrence of CDRH, Office of Device Evatuation (ODE) OLUI

Prescription Use (Per 21 CFR 801.109)

.

19

510 (k) Number (if known):

Device Name: Intended Use:

: ·

9EVF4 Curved Array Transducer for use with ACUSON S2000 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
Intraoperative
Abdominal
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# 063803, K072786, K081148, K090334

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding Note 3

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 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Dev aluation and Safet

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaniation (QDE) CD CD

20

Siemens Medical Solutions, Inc. Ultrasound Division

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

V5Ms Multiplane TEE Transducer for use with ACUSON S2000 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
Abdominal
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P	BMDC
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334

Additional Comments: n/a

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevies: Evaluation (QBE) ○ V )

Prescription Use (Per 21 CFR 801.109)

KOS

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510K K093812

S2000 510(k) Submission

Page 29 of 52

21

510 (k) Number (if known):

Device Name:

Intended Use:

17L5HDS Linear Array Transducer for use with ACUSON S2000 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
Abdominal
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
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,
11,14
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 K# 063085, K072786, K082142, K090334

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic 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

(Division Sign-Off)

Division of Radiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety

510K K093812

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22

510 (k) Number (if known):

Device Name: Intended Use:

18L6 HD Linear Array Transducer for use with ACUSON S2000 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
Abdominal
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
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		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, K082142, K090334

Additional Comments:

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

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI

Note 15 AHP Note 16 Custom Tissue Imaging

S

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510K K093812

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23

510 (k) Number (if known):

Device Name:

Intended Use:

8V3 Phased Array Transducer for use with ACUSON S2000 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
Abdominal
Intraoperative
Neurological
Pediatric		P	p	P	P	0	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)
Nennatal Cardiac		P	P	P	P	P	P	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7 Power SieScape panoramic imaging

Note 8

Note 10 Clarify VE vascular enhancement technology

(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

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Prescription Use (Per 21 CFR 801.109)

24

510 (k) Number (if known):

Device Name: Intended Use: 4V1c Phased Array Transducer for use with ACUSON S2000 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
Abdominal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Neurological		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Pediatric		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	BMDC	Note 2 3 4 5 7 8 10
Cardiac		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	BMDC	Note 2 3 4 5 7 8 10
15
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
Neonatal Cardiac		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 052410, 051139, 032114, 022567, 063085, K090334

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 10 Clarify VE vascular enhancement technology

Note 15 AHP

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K09812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (QDE) (2DE) (2)

25

510 (k) Number (if known):

Device Name: Intended Use:

6L3 Transducer for use with ACUSON S2000

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
Abdominal		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Intraoperative
Neurological		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Pediatric
Small Organ		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Neonatal Cephalic
Adult Cephalic
Cardiac		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	BMDC	Note 2 3 4 5 7 8 10
15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Musculo-skeletal
Superficial		P	P	P	P	P	P	BMDC	Note 2 3 4 5 7 8 10
Other (specify)

N = new indication; P = previously cleared by FDA K#'s 052410, 051139, 032114, 022567, 002807, 973767, 063085, K090334

Additional Comments:

Ensemble tissue harmonic imaging Note 2

SieClear multi-view spatial compounding Note 3

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

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

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Di

510K 4093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OBE) OTTJ (

26

510 (k) Number (if known):

Device Name: Intended Use:

EV8C4 Transducer for use with ACUSON S2000 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
Abdominal
Intraoperative
Neurological
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 052410, 051139, 032114, 022567, 002807, 973767, 063085, K090334

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology

J-A-D

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (OBE)-

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

27

510 (k) Number (if known):

Device Name: Intended Use:

V7M TEE Transducer for use with ACUSON $2000 Ultrasound imaging or fluid flow analysis of the human body as follows:

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

P=previously cleared by the FDA under premarket notifications #K052410, #K051139, #K041319, #K032114, and #K022567.

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 10 Clarify VE vascular enhancement technology

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

Concurrence of CDRH	Office of Device Evaluation (ODE) OIVD
---------------------	----------------------------------------

(Division Sign-Off) Prescription Use (Per 21 CFR 801.109) Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K093812

S2000 510(k) Submission

Page 36 of 52

28

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter for use with ACUSON S2000

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
Ophtalmic
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 K992631, K033650, K042593, K071234.

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

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Exaluation (ODE) ODE) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K0938/2

29

510 (k) Number (if known):

Device Name: Intended Use:

(

AcuNav 10F Ultrasound Catheter for use with ACUSON S2000

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.

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| Ophtalmic | | | | | | | | | | | |
| 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 K992631, K033650, K042593, K071234.

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

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (GDE) OTY( Prescription Use (Per 21 CFR 801.109)

CFR 601.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K093812