Predicate Devices

K072786, K063803, K053803, K063085, K032114

Reference Devices

K072786, K063803, K053803, K063085, K032114

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML algorithms in medical imaging.

Therapeutic

No.
The device is described as an "ultrasound imaging system" intended for various diagnostic applications and for measuring anatomical structures for "clinical diagnosis purposes." There is no mention of treating or curing any conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the system provides information "that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Additionally, the "Device Description" section lists several safety standards related to "Diagnostic Ultrasound."

SaMD (Software as a Medical Device)

No

The device description explicitly refers to "ultrasound imaging systems" and lists compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.), indicating it is a physical hardware device that includes software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the S2000™ ultrasound imaging system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly describes the system for various in vivo (within the living body) imaging applications and measurements of anatomical structures. IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body).
Device Description: The safety standards listed are for medical equipment used on patients, not for laboratory diagnostic equipment.
Input Imaging Modality: Ultrasound is an imaging modality used to visualize structures within the body, not to analyze biological samples.
Anatomical Site: The listed anatomical sites are all locations within the human body.

The device is a diagnostic ultrasound system used for medical imaging and measurements performed directly on patients.

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, 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.

Product codes

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 l 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, Pediatric, Small Parts (e.g., breast, testes, thyroid, penis, prostate), Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal (Conventional), Musculo-skeletal (Superficial), Peripheral Vessel, Trans-esophageal, Transrectal, Transvaginal.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Clinician, Physician

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)

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

Reference Device(s)

K072786, K063803, K053803, K063085, K032114

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Product Code 90-ITX

Kof2/42

510(k) Summary Prepared October 27, 2008

| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | NOV 13 2008 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Shelly Pearce
Telephone: (650) 694-5988
Fax: (650) 694-5580 | |
| Submission Date: | October 13, 2008 | |
| Device Name: | Acuson S2000TMUltrasound System | |
| Common Name: | Diagnostic Ultrasound System | |
| Classification: | | |
| Regulatory Class: | II | |
| Review Category: | Tier II | |
| Classification Panel: | Radiology | |
| | Ultrasonic Pulsed Doppler Imaging System FR # 892.1550
Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System FR # 892.1560
Product Code 90-IYO | |

FR # 892.1570

A. Legally Marketed Predicate Devices

Diagnostic Ultrasound Transducer

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:

" 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 l 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
r 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 ■

S2000 510(k) Submission

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, 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.

S2000 510(k) Submission

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2008

Ms. Shelly Pearce Regulatory Affairs Siemens Medical Solutions USA, Inc. P.O. Box 7393, 1230 Shorebird Way MOUNTAIN VIEW CA 94039

Re: K082142

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: September 17, 2008 Received: September 22, 2008

Dear Ms. Pearce:

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 probibitions 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 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Arrav 4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array

3

10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array 9EVF4 Curved Array V5Ms Multiplane TEE 17L5HDS Linear Array 18L6 HD Linear Array 8V3 Phased Array

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

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

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

Sincerely yours,

Herbert Weiner

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

4

1.3 Indications for Use

510(k) Number (if known): K082142
Device Names $3000M Diganestis

Device Name: S2000™Diagnostic Ultrasound Sys

Indications for Use:

The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiae, 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.

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)

S2000 510(k) Submission

Page 12 of 43

Huldeee

5

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (it known):

Device Name:

Intended Use:

ACUSON S2000 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
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
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	Note 2,3,4,5,7,8,10,
11, 14
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
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
Trans-esophagea!	P	P	P	P	P	P	P	BMDC
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
Intravascular
Peripheral vessel	P	P	P	P	P	P	P	BMDC	Note2,3,4,5,6,7,8,10,
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	P	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	P	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA, K072786; E = added under Appendix E

Nota 1 For example: breast, testes, thyrold, penis, prostate, etc.

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology 서에는 온 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 For example: vascular, abdominal

Clarity VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear multi-view spatial compounding
Note 13 STIC

Note 13 $TIC

Note 14 eSie™ Touch elasticity Imaging

(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

S2000 510(k) Submission

Page 13 of 43

Hulu Leem

(Division Sigh Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number

6

510 (k) Number (if known):

Device Name: CW2 Probe for use with ACUSON S2000 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
Abdominal					P
Intraoperative
(Note 9)				P	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; E = added under Appendix E

Additional Comments:

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

Nole 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)

S2000 510(k) Submission

Page 14 of 43

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

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; E = added under Appendix E

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 Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

Page 15 of 43

Hahn Leussen

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological De 510(k) Number

8

Diagnostic Ultrasound Indications for Use Form

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:

		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
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# 053803, K072786; E = added under Appendix E

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2

Ensemble tissue harmonic imaging Nota 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

Clarify VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear multi-view spatial compounding Note 12

Note 14 eSie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 16 of 43

Helmut Reem

(Division Sian-Off uctive. Abdominal and Radiological De 510(k) Number

9

Dlagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

9L4 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		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
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10, 11
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 2,3,4,5,6,7,8,10, 11, 14
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Other (specify)

N = naw indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E

Additional Comments:

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

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding
Tissue Equalization Technology Note 3 Nole 4

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

B&W SleScape panoramic imaging Note 7

Note 8

Bower SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10

Note 11 Advanced Slectear multi-view spatial compounding

Nole 12

Note 14 eSie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 17 of 43

Helene Demu

Division of Reproductive, Abdomin Radiological Di 510(k) Number

10

Diagnostic Ultrasound Indications for Use Form

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; E = added under Appendix E

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-lime 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SiaScape panoramic Imaging

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)

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

Page 19 of 43

Hulutem

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

11

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	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
Intraoperative
Abdominal
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 K# 063085, K072786; E = added under Appendix E

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
B&W SieScape panoramic imaging Nole 5 Note 7

Note B Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear multi-view spatial compounding
Note 14 eSie™ Touch elasticity imaging

Note 14 eSia™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 20 of 43

Helsu Keen

(Division Sign-Off) Divi ision of Reproductive. Abdomin Radiolo 510(k) Number

12

Diagnostic Ultrasound Indications for Use Form

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
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, K032114; E = added under Appendix E

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

SieClear multi-view spatial compounding
TIssue Equalization Technology Note 3 Nolo 4

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic Imaging

Nole 8

Dow Stocope panoramic imaging
Power SieScape panoramic imaging
Clarity VE vascular enhancement technology Note 10

Advanced Sieclear multi-view spatial compounding Note 11

Note 12

Note 14 eSie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 21 of 43

Herbert Linn

(Division Sign-Off) Division of Reproductive, Abdomina Radiological Device 510(k) Number

13

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
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; E = Rdded under Appendix E

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 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarity VE vascular enhancoment technology

Note 11 Advanced Siectear multi-view spatial compounding

Note 14 eSie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 22 of 43

Hecho

DIVIsion of Reproductive, Abdominal an 510(k) Number

14

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; E = added under Appendix E

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 10 Clarity 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)

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

Page 23 of 43

Hubert Lemmer
(Division Signature)

(Division Sigh-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number

15

510 (k) Number (if known):

Device Name:

14L5 SP Linear Array Transducer for use with ACUSON S2000

Diagnostic imaging or fluid flow analysis of the human body as tollows: Indications For Use:

	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
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note2,3,4,5,6
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; E = added under Appendix E

Additional Comments:

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

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
For example: vascular, abdominal

Note 9

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear multi-view spatial compounding

Note 14 usie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 24 of 43

Hubert Leem

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

16

510 (k) Number (if known):

Device Name: 7CF2 Curved array mechanical 3D transducer for use with ACUSON $2000 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,
11,13
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,
11, 13
Intraoperative
Abdominal
Intraoperative
Nourological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethrai
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skelatal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 063803, K072786; E = added under Appendix E

Additional Comments:

Ensemble 1issue harmonic imaging
SieClear multi-view spatial compounding
Tissue Equalization Technology Note 2 Note 3

Note 4

Note 5 3-Scape real-time 3D imaging

Nota 7 B&W SieScape panoramic imaging

Note 8

Power SieScape panoramic imaging
Clarity VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear multi-view spatial compounding

Note 13 STIC

(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}

S2000 510(k) Submission

Page 25 of 43

vision Sign-Off) of Reproductive, Abdominal 510(k) Num

17

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)

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spalial compounding

Note 4 Tissue Equalization Technology

3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 8 Note 10

Note 11

Advanced Sieclear multi-view spatial compounding

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

Prescription Use (Par 21 CFR 801.109)

S2000 510(k) Submission

Page 26 of 43

Hachlam

of Reproductive. Abdominal and Radiological De 510(k) Number

18

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; E = added under Appendix E

Additional Comments: Na

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

f

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

Page 27 of 43

Helena Leem

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

19

Dlagnostic Ultrasound Indications for Use Form

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; E = added under Appendix E

Additional Comments:

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

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note S 3-Scape real-time 3D imaging B&W SieScape panoramic imaging Note 7

Note 8

Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10

Note 11 Advanced Sieclear multi-view spatial compounding

Note 14 eSie™ Touch elasticity imaging

(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)

S2000 510(k) Submission

Page 28 of 43

Hels Rem

ivision Sian-Off Division of Reproductive. Abdominal and 510(k) Number

20

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 tollows:

	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)		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11,14
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11,14
Laparoscopic
Musculo-skeletal
Conventional		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11,14
Musculo-skeletal
Superficial		N	N	N		N	N	BMDC	Note 2,3,4,5,7,8,10,
11,14
Other (specify)

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

Additional Comments:

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

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology Advanced Sieclear multi-view spatial compounding Note 11

Note 14 eSie™ Touch elasticity imaging

HOLD 14 - ESID - Touch Elasticity Imaging

(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)

S2000 510(k) Submission

Page 29 of 43

signature

ivision S 510(k) Nur

21

Diagnostic Ultrasound Indications for Use Form

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	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
Abdominal
Intraoperative
Neurological
Pediatric		P	P	P	P		P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P		P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		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	BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E

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 Nota 5

Note 6 Cadence contrast agent imaging

Nota 7 B&W SieScape panoramic Imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

Prescription Use (Per 21 CFR 801.109)

S2000 510(k) Submission

Page 30 of 43

(Division Sign-Off) (Division Sign On)
Division of Reproductive, Abdominal and Radiologica 510(k) Number