Predicate Devices

Acuson Antares Ultrasound System (no K/DEN number provided in text)

Reference Devices

K072786, K# 063803, K# 063085, K032114, K# 052410, CS 1.139, 04.1.19, 032114, 022567, K# 082142, K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging capabilities and measurement packages, with no mention of AI or ML technologies.

Therapeutic

No.
The device is described as an "ultrasound imaging system" intended for "clinical diagnosis purposes" that provides information to the clinician "adjunctively with other medical data" and "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 Imagino'". This indicates a diagnostic rather than therapeutic purpose.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the system provides "calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Furthermore, the "Device Description" explicitly lists "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards" as a standard the device is designed to meet.

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 medical devices used to perform tests 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. While it provides measurements and calculations that can be used adjunctively for diagnosis, it does not perform tests on biological samples in vitro.
Intended Use: The intended uses listed are all related to imaging and measuring anatomical structures within the body (in vivo).
Device Description: The safety standards listed are for medical equipment and diagnostic ultrasound, not specifically for IVD devices.

The device is a diagnostic imaging system that provides information to the clinician, but it does not fit the definition of an In Vitro Diagnostic device.

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.

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 Imagino".

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

90-IYN, 90-1YO, 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 1
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
AIUMNEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
T 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/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Trans-esophageal, Transrectal, Transvaginal.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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.

Acuson Antares Ultrasound System (no K/DEN number provided in text)

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.

K072786, K# 063803, K# 063085, K032114, K# 052410, CS 1.139, 04.1.19, 032114, 022567, K# 082142, K#'s 052410, 051139, 041319, 032114, 022567, 002807, 973767

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

IC0{0334

S2000 Ultrasound System 510(k) Submission

510(k) Summarv Prepared February 3, 2009

FEB 2 0 2009 Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580

Submission Date: February 3, 2009

Device Name: Acuson S2000™ Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System

Classification:

Regulatory Class: 11 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 90-1YO 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:

UL 60601-1, Safety Requirements for Medical Equipment ■
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards 1
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 해
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 를 Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUMNEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound 내
트 93/42/EEC Medical Devices Directive
Safety and EMC Requirements for Medical Equipment 파
- EN/IEC 60601-1 내
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
IEC 1157 Declaration of Acoustic Power 체
ISO 10993-1 Biocompatibility 비

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.

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 Imagino".

2

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

.

Public Health Service

FEB 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090334 . .

Trade/Device Name: ACUSON S2000m 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 9, 2009 Received: February 10, 2009

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, buting of devices, good manifacturing 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 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array

4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array 10V4 Phased Array

3

Enclosure(s)

14L5 SP Linear Array 7CF2 Curved Array 9EVF4 Curved Array V 5Ms Multiplane TEE 17L5HDS Linear Array 18L6 HD Linear Array 8V3 Phased Array 4V1c Phased Array 613 EV8C4

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 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 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 totterspiesses contact that an (240) 276-3566: ·

Sincerely yours,

Heelt Lewen
Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

4

1.3 Indications for Use

510(k) Number (if known):

K090334

Device Name: S2000™Diagnostic Ultrasound System

Indications for Use: K090334

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 cephalio, 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".

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

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

(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number K090334

S2000 510(k) Submission

Page 12 of 46

5

S2000 Ultrasound System 510(k) Submission

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:

	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	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
2,3,4,5,6,7,8,10,15
Trans-esophageal	P	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	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	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

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

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
Note 9 For example: vascular, abdominal Note 10

Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding

Note 13 STIC
eSie™ Touch elasticity imaging Note 14

etc. Note 15 AHP

(Division Sign-Off)
Division

Division of Reproductive, Abdominal and

Reproductive, Abdominal and
Radiological Devices
510(k) No.

510(k) Number

K010334

S2000 510(k) Submission

Page 18 of 1326

. W

6

S2000 Ultrasound System 510(k) Submission

(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:

14.73

	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)

Nia such indication; P = 5 rowlously gleared by FDA ill 088803, KO72785

Additional Comments:

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

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)

Hula Levin

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090334

S2000 510(k) Submission

Page 19 of 1326

7

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

CW5 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

Additionshomments:

· Forexample: breast, testes, thyroid, panis, prostate, 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)

(Division Sign-Off)

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

Page 20 of 1326

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# 063803, K072788

Accitional Comments:

: Note 'i' For example: breast, testes, thyreigl, gents, prostate, atc

Ensemble tissue harmonic imaging Note 2

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

Advanced Sieclear spatial compounding Note 11

eSie™ Touch elasticity imaging Note 14

(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)
(Division Sign-Off)
Division of Reproductive, Abdominal and, Radiological Devices
510(k) Number	K090334

S2000 510(k) Submission	Page 16 of 46
Page 21 of 1326

9

Diagnostic Ultrasound Indications for Use Form

్లో ప్రా

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:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10, 11
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		N	N	N		N	N		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 (specify)

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

Additional Commento:

For example: breast, testes, thyrold, panis, prostate, Note - i . -

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 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note B
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear spatial compounding
Not

Not

ote 14	eSie™ Touch elasticity imaging
ote 15	AHP

(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)
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

K 90324

510(k) Number

S2000 510(k) Submission

Page 22 of 1326

Page 17 of 46

10

Diagnostic Ultrasound Indications for Use Form

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:

							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 2,3,4,5,6,
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

Actificital Coginants:

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 6 Cadence contrast agent imaging
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
eSie™ Touch elasticity imaging Note 14

Halstein

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

(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 1326

11

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

Additional Comments:

Ensemble tiesus hamonia imaging NOVER 2

Note. 3 SieClear mult - tew spatiat compounding

Tissua Equalization Technology Note. J. ..

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

Clarify VE vascular enhancement technology Note 10

(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

(Division' Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

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

Prescription Use (Per 21 CFR 801.109)

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

S2000 510(k) Submission

Page 27 of 1326

15

Diagnostic Ultrasound Indications for Use Form

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

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Nord 3 SieClear multi view spetial compounding

Noté 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Nota 7

Note 8 Power SieScape panoramic imaging

Clarify VE vascular enhancement technology Note 10

Prescription Use (Per 21 CFR 801.109)

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

S2000 510(k) Submission

Page 28 of 1326

16

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Indications For Use: 1 4L5 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
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	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, K072

Additional Commondes: s

Note T Forvexample: breast, hestes, thyroid, penis, prostate,
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
Power SieScape panoramic imaging Note 8
For example: vascular, abdominal Note 9
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging Note 14

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AND THE RACK IS NEEDED) Concurrence of CDRH, Office of Device Evaluation CODE

(Division Sign-Off)

Prescription Use (Per 21 CFR 80) Dillistion of Reproductive, Ab-

Radiological Devices

510(k) Number

S2000 510(k) Submission

Page 29 of 1326

Page 24 of 46

Note 15 AHP

Note 15 AHF

17

Diagnostic Ultrasound Indications for Use Form

Siemens Medical Solutions, Inc. Ultrasound Division

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:

| Clinical Application (Specify) | |----------------------------------| | | A Doppler | Amplitude
Doppler | Color Velocity
Imaging | (Specify) |
| Ophthalmic | | Fetal | 11,13 |
| Abdominal | 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) | | Mode of Operation | | | | | | | | Other
|
-------------------|---|---|-----|-----|------------------|----------------------|---------------------------|--------------------|--------------------------------|
| B | M | PWD | CWD | Color
| Combined
| | | | | | | | | |
| P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
| P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |

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

· Additional Comments:

Note: 2 Ensemble tissue harmonicimaging

SleClear multi-vlow 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

Clarify VE vascular enhancement technology Note 10

Advanced Sieclear spatial compounding Note 11

. Note 13 STIC

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

(Division Sign-Off)

Prescription Use (Per 21 CFR 801 (Division Sign-Off)
Prescription Use (Per 21 CFR 801 Affitsion of Reproductive, Abdominal and

Radiological Devices
510(k) Number K090

S2000 510(k) Submission

Page 30 of 1326

18

Diagnostic Ultrasound Indications for Use Form

なり、

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	ਉ	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	p	p		P
ﺎ ﺍ	P		BMDC	Note 2,3,4,5,7,8,
10,111
1, 2
Abdominal	, "		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------			్

        | : "                                                                                                                                                                            | ・・                           |                          |                             |

45 - 27 - 25 - 2015 | | | | 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | 10:50 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 12 - 12 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - | | いついるときてなっているとなるときているというと | : |

( = new indication; = p svaously Neared by FDA KC 063803, KO712786

Additional Comments:

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

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA GE Concurrence of CDRH, Office of Device Evaluation (ODIE)

(Division Sign-OM

Prescription Use (Per 21 CFR Bivish of Reproductive, Abdominal and

Radiological Devices
510(k) Number

S2000 510(k) Submission

Page 31 of 1326

Page 26 of 46

19

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
Abdomina!
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

Additional Comments: n/a

(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)

(R 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090334

S2000 510(k) Submission

Page 32 of 1326

20

Diagnostic 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; Pi= previously cleared by SDA Kit DESUBS, K.

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, atc. Note 1
Note 2 Ensemble tissue harmonic imaging
Note 3 SiaClear multi-view spatial 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 Note 8
Clarify VE vascular enhancement technology Note 10
Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging Note 14

te 14 esis "(Quasi-) elasticity imaging

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

510(k) Number

(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 33 of 1326

Page 28 of 46

21

S2000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

15 11:4

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
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	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 stearied by PDA M082142

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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
Clarify VE vascular enhancement technology Note 10
Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging Note 14

Note 15 AHP

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

(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 34 of 1326

Page 29 of 46

22

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	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
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 3,4,6
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)
Neonatal Cardiac		P	P	P	P	P	P	BMDC	Note 3,4,6

N = new indication; P = previously classed by ITDA ! # 063085; K072786

Additional Comments:

Ensemble tissue harmonic imaging Note 2

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note B Cadence contrast agent imaging

Note 7 B&W SieScape 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 Concurrence of CDRH, Office of Device Evaluation (ODE

Division Sign-Off) Prescription Use (Per 21 CFR 801. 109

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K890334

S2000 510(k) Submission

Page 35 of 1326

23

Diagnostic Ultrasound Indications for Use Form

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# & 052410, CS 1.139, 04.1.19, 032114, 022567, 063085

Additional Comments: ..

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 Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

(Division Sign-Off)
Division of Reproductive, Abdominal and

Radiological Devices 510(k) Number

Devices
er K090334

(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 36 of 1326

24

Diagnostic Ultrasound Indications for Use Form

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, 041319, 032114, 022567, 002807, 973767, 063085 Additional Comments:

Ensemble tissue harmonis imaging Note 2

Note 3 SleClear multi-view spatial compounding

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

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

Note 15 АНР

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

Prescription Use (Per 21 CFR 80(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices

510(k) Number

S2000 510(k) Submission

Page 37 of 1326

Page 32 of 46

25

Diagnostic Ultrasound Indications for Use Form

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)

(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

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