ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K130619
• Device Name: ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2013-03-21 ( 14 days)
• Product Code: IYN , ITX , IYO , OBJ
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K121138 , K122825
• Predicate For: K132804 , K143298 , K152467

Intended Use

The S1000™ 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 adiunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

Device Description

The S1000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S3000 system (K122825) which is a legally marketed device.

AI/ML Overview

The provided 510(k) summary for the Acuson S1000™ Diagnostic Ultrasound System does not include a separate section for acceptance criteria or details regarding a study specifically designed to prove the device meets performance acceptance criteria.

Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (Acuson S3000 Ultrasound System (K122825)) rather than providing detailed performance metrics or clinical study results for the S1000 itself.

Here's an analysis based on the information provided, addressing the requested points where possible, and noting where information is absent:

---

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Acuson S3000 Ultrasound System). Therefore, direct numerical performance metrics or acceptance criteria for the S1000 are not detailed. The "performance" is implicitly tied to meeting the same functional capabilities and safety standards as the predicate device.

The tables in sections {6} (Summary of Technological Characteristics - New Device Compared to Predicate) and {7}-{29} (Diagnostic Ultrasound Indications for Use Form for various transducers) indicate that the S1000 system and its transducers support various clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) "P" (previously cleared by FDA), indicating equivalence to the predicate's capabilities.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. As clinical data was "not required" (see point 8 below), there wouldn't be a test set with patient data for clinical performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Given that clinical data was not required, there was no independent test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. See point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC study, AI assistance, or any effect size related to human reader improvement. The device is a diagnostic ultrasound system, and the submission does not indicate any AI components or human-in-the-loop performance studies of that nature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is an ultrasound system, not an AI algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided for the device itself. For the Arterial Health Package (AHP) software feature, it mentions referencing "normative tables that have been validated and published in peer-reviewed studies." This implies that the ground truth for these normative tables was established through published research, but it doesn't specify if new ground truth was established for this submission.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" in the context of device performance or algorithms in this submission.

9. How the Ground Truth for the Training Set was Established

This information is not provided. See point 8.

---

Summary of Device Acceptance Approach:

The core of this 510(k) submission for the Acuson S1000 Diagnostic Ultrasound System is the argument of substantial equivalence to an existing, legally marketed predicate device (Acuson S3000 Ultrasound System (K122825)).

The submission states:

• "The S1000™ Ultrasound System is substantially equivalent to the company's own S3000 Ultrasound System (K122825)." {1-0}
• "Since the S1000 uses the same technology and principles as existing devices, clinical data is not required." {3-0}

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the S1000:

1. Has the same intended use as the predicate device {1-0, 1-1, 6-0}.
2. Has similar technological characteristics to the predicate device {1-1, 6-0}. The tables in section {6} highlight the features and characteristics that are common or equivalent between the S1000 and S3000.
3. Complies with relevant safety and performance standards for medical devices (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1 for biocompatibility) {3-0}. These non-clinical tests would serve as the primary evidence for safety and basic performance conformance.

Summary

{0}------------------------------------------------

K130619
Page 1 of 4

510(k) Summarv Prepared February 4, 2013

MAR 2 1 2013

510(k) Submission

1. Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division
	685 East Middlefield RoadMountain View, California 94043

Contact Person:	Shelly Pearce
	Telephone:	[phone]
	Fax:	[phone]

• 2. Device Name: Acuson S1000™ Diagnostic Ultrasound System
  • Common Name: Diagnostic Ultrasound System

Classification:

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

Ultrasonic Pulsed Doppler Imaging System	FR # 892.1550	Product Code 90-IYN
Ultrasonic Pulsed Echo Imaging System	FR # 892.1560	Product Code 90-IYO
Diagnostic Ultrasound Transducer	FR # 892.1570	Product Code 90-ITX
Diagnostic Ultrasound Catheter	FR # 870.1200	Product Code OBJ

3. Legally Marketed Predicate Devices

The Acuson S1000™Ultrasound System is substantially equivalent to the company's own S3000 Ultrasound System (K122825).

4. Device Description:

The S1000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S3000 system (K122825) which is a legally marketed device.

5. Intended Use

The $1000™ 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.

ーーーーーーーーーーーーーーーーーーーー

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult

{1}------------------------------------------------

S1000 Ultrasound System
510(k) Submission

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 adiunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

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

6. Summary of Technological Characteristics - New Device Compared to Predicate

	Feature / Characteristic	AcusonS1000	AcusonS3000K122825
	Indications for Use:
■	Fetal	√	√
■	Abdominal	√	√
■	Intraoperative abdominal andvascular	√	√
■	Intraoperative neurological	--	--
■	Pediatric	√	√
■	Small Organ	√	√
■	Neonatal cephalic	√	√
■	Adult Cephalic	√	√
■	Cardiac	√	√
■	Trans-esophageal	√	√
■	Transrectal	√	√
■	Transvaginal	√	√
■	Peripheral vessel	--	--
■	Laparoscopic	--	--
■	Musculo-skeletal (conventional)	√	√
■	Musculo-skeletal (superficial)	√	√
	Center Frequencies Supported:
■	2.0 MHz	√	√
■	3.0 MHz	√	√
■	3.2 MHz	√	√
■	3.3 MHz	√	√
■	4.2 MHz	√	√
■	4.4 MHz	√	√
	Feature / Characteristic	Acuson S1000	Acuson S3000K122825
	4.8 MHz	√	√
	5.0 MHz	√	√
	5.2 MHz	√	√
	6.0 MHz	√	√
	6.5 MHz	√	√
	6.9 MHz	√	√
	9.5 MHz	√	√
	10.0 MHz	√	√
	Modes:
	B	√	√
	Parallel processing in B mode	√	√
	M	√	√
	PWD (Pulsed Wave Doppler)	√	√
	CWD (Continuous Wave Doppler)	√	√
	D (Color Doppler)	√	√
	Amplitude Doppler	√	√
	Combined (BMDC)	√	√
	Features:
	Quad processing in color	√	√
	Native™ tissue harmonic imaging	√	√
	SieScape™ panoramic imaging	√	√
	Color SieScape™ panoramicimaging	√	√
	3-Scape ™ real-time 3D imaging	√	√
	fourSight™ 4D transducertechnology	√	√
	TEQ™ ultrasound technology	√	√
	Cardiac Imagingphysiological signal display	√	√
	syngo ® Auto OB measurements	√	√
	Advanced SieClear™ spatialcompounding	√	√
	STIC (Fetal Heart Imaging)	√	√
	Amnioscopic rendering	√	√
	Cadence contrast agent imaging	√	√
	Clarify™ vascular enhancementtechnology	√	√
	eSie™ Touch elasticity imaging	√	√
	eSie Fusion	√	√
	syngo ® Auto Left heart	√	√
	syngo ® Velocity Vector Imaging	√	√
	Semi Auto-segmentation (eSieCalc)	√	√
	Custom Tissue Imaging / Speed ofSound	√	√
	AHP	√	√
Feature / Characteristic	AcusonS1000	AcusonS3000K122825
Output Display Standard (Track 3)	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√
Indications for Use	√	√

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.

S1000 Ultrasound System 510(k) Submission

{3}------------------------------------------------

K130619
page 4 of 4

S1000 Ultrasound System 510(k) Submission

7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

• UL 60601-1, Safety Requirements for Medical Equipment ■
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards ■
• 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 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
• l Safety and EMC Requirements for Medical Equipment
  • EN/IEC 60601-1 .
  • . EN/IEC 60601-1-1
  • s EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power ●
• ISO 10993-1 Biocompatibility D

Cleared patient contact materials, electrical and mechanical safety are unchanged.

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

Since the $1000 uses the same technology and princibles as existing devices. clinical data is not required.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the S1000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings.

Public Health Service

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

March 21, 2013

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

Re: K130619

Trade/Device Name: S1000" Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX and OBJ Dated: March 6, 2013 Received: March 7, 2013

Dear Mr. Job:

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

This determination of substantial equivalence applies to the following transducers intended for use with the S.1000 Diagnostic Pulsed Doppler Imaging System, as described in your premarket notification:

Transducer Model Numbers

CW2	14L5	14L5SP	AcuNav 10F
CW5	4P1	9EVF4	V7M
4C1	V5Ms	7CF2	6C1HD
EC9-4	6C2	4V1c	6L3
9L4	4V1	EV8C4
8V3	10V4	AcuNav 8F

{5}------------------------------------------------

Page 2 - Mr. Mark Job

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh7)

for

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

Enclosure

{6}------------------------------------------------

1.3 Indications for Use

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

Device Name: S1000™Diagnostic Ultrasound System

Indications for Use:

The S1000™ 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 Imaging".

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

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{7}------------------------------------------------

1.3 Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

ACUSON S1000 Ultrasound System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic	N	N	N	N	N	N	N		BMDC
Fetal	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 13, 16
Intraoperative(Note 9)	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 14
IntraoperativeNeurological	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11, 14
Pediatric	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11
Small Organ(Note 1)	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14, 16
Neonatal Cephalic	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10
Cardiac	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,6,7,8,10,15
Trans-esophageal	N	N	N	N	N	N	N		BMDC	Note 4
Transrectal	N	N	N	N	N	N	N		BMDC	Note 2,3,4.5,7,8,10,11,14
Transvaginal	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel	N	N	N	N	N	N	N		BMDC	Note2,3,4,5,6,7,8,10,11,14,15
Laparoscopic
Musculo-skeletalConventional	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial	N	N	N	N	N	N	N		BMDC	Note 2,3,4,5,7,8,10,11,14
Other (specify)Neonatal Cardiac	N	N	N	N	N	N	N		BMDC	Note 3,4,6, 10

N = new indication; P = previously cleared by FDA K121138, 122825

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

SieClear multi-view spatial compounding Note 3

3-Scape real-time 3D imaging Note 5 Note 7

B&W SieScape panoramic imaging Note 9 For example: vascular, abdominal

Note 11 Advanced Sieclear spatial compounding

eSie™ Touch elasticity imaging / FTI Note 14

Note 16 Custom Tissue Imaging Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clanfy VE vascular enhancement technology

• Note 13 STIC
  Note 15 AHP

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{8}------------------------------------------------

510 (k) Number (if known):

Device Name:	CW2 Probe for use with ACUSON S1000
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological
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-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{9}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

CW5 Probe for use with ACUSON S1000

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative(Note 9)					P
IntraoperativeNeurological					P
Pediatric					P
Small Organ(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletalConventional					P
Musculo-skeletalSuperficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

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

Note 9 For example: vascular, abdominal

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)

{10}------------------------------------------------

510 (k) Number (if known):

Device Name:

Intended Use:

EC9-4 Curved Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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.
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

Note 6 Cadence contrast agent imaging

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 14 eSie™ Touch elasticity imaging / FTI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{11}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

9L4 Linear Array Transducer for use with ACUSON $1000 Ultrasound imaging or fluid flow analysis of the human body as follows.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2.3,4,5,7,8,10, 11
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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		P	P	P		P	P		BMDC
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-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,6,7,8,10, 11, 14
Musculo-skeletalSuperficial		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# 121138, 122825

Additional Comments:

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

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 11 Advanced Sieclear spatial compounding

eSie™ Touch elasticity imaging / FTI Note 14

Note 15 AHP

Note 16 Custom Tissue Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k)

{12}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

14L5 Multi-D Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3.4,5,7,8,10,11, 14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

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 / FTJ

Custom Tissue Imaging Note 16

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{13}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4P1 Phased Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

Cadence contrast agent imaging Note 6

B&W SieScape panoramic imaging Note 7

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{14}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	6C2 Curved Array Transducer for use with ACUSON S1000Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 14, 16
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

• Ensemble tissue harmonic imaging Note 2
• Note 4 Tissue Equalization Technology

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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

Note 8 Power SieScape panoramic imaging

Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{15}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	4C1 Curved Array Transducer for use with ACUSON S1000
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

Ensemble tissue harmonic imaging Note 2

• Note 4 Tissue Equalization Technology
  Cadence contrast agent imaging Note 6

Power SieScape panoramic imaging Note 8

Advanced Sieclear spatial compounding Note 11

• Note 16 Custom Tissue Imaging
• SieClear multi-view spatial compounding Note 3
  3-Scape real-time 3D imaging Note 5

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(K)

{16}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:		6C1HD Curved Array Transducer for use with ACUSON S1000
Intended Use:									Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

• Ensemble tissue harmonic imaging Note 2
• Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

• Power SieScape panoramic imaging Note 8
  Advanced Sieclear spatial compounding Note 11

Note 16 Custom Tissue Imaging

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

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{17}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethra!
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138. 122825

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 4 Tissue Equalization Technology

Note 7 B&W SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

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

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

.

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) _

{18}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

10V4 Phased Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{19}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Indications For Use:

14L5 SP Linear Array Transducer for use with ACUSON S1000 Diagnostic imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(Note 9)		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10
IntraoperativeNeurological		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	Note 2,3,4,5,6,7,8,10, 11,14,15
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11,14
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

Cadence contrast agent imaging Note 6

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 14 eSie™ Touch elasticity imaging / FTI

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

S1000 510(k) Submission

Note 15 AHP

Note 16 Custom Tissue Imaging

Note 15 AHP

{20}------------------------------------------------

510 (k) Number (if known):

Device Name:	7CF2 Curved array mechanical 3D transducer for use with ACUSON S1000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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 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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{21}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:

Intended Use:

9EVF4 Curved Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMDC	Note 2,3,4,5,7,8,10,11, 13
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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 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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{22}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	V5Ms Multiplane TEE Transducer for use with ACUSON S1000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal		P	P	P	P	P	P		BMDC	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

Additional Comments:

Note 4 Tissue Equalization Technology

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{23}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use: 8V3 Phased Array Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2,3,4,5,7,8,10
Abdominal
IntraoperativeAbdominal
IntraoperativeNeurological
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-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)Neonatal Cardiac		P	P	P	P	P	P		BMDC	Note 3,4,6

N = new indication; P = previously cleared by FDA K#121138. 122825

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{24}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:Intended Use:	4V1c Phased Array Transducer for use with ACUSON S1000Ultrasound imaging or fluid flow analysis of the human body as follows:
							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10
IntraoperativeNeurological		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 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
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 121138. 122825

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

Cadence contrast agent imaging Note 6

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Clarify VE vascular enhancement technology Note 10

Note 15 AHP

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health ર I 0(k)

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S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:	6L3 Transducer for use with ACUSON S1000
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Abdominal
IntraoperativeAbdominal		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
IntraoperativeNeurological		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Pediatric
Small Organ		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,1
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 1015
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11 15
Laparoscopic
Musculo-skeletalConventional		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11
Musculo-skeletalSuperficial		P	P	P	P	P	P		BMDC	Note 2 3 4 5 7 8 10,11

N = new indication; P = previously cleared by FDA K # 121138, 122825

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

Cadence contrast agent imaging Note 6

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 15 AHP

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)________________________________________________________________________________________________________________________________________________________________________

{26}------------------------------------------------

510 (k) Number (if known):

Device Name:

Intended Use:

EV8C4 Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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
IntraoperativeAbdominal
IntraoperativeNeurological
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 7 810
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by FDA K# 121138, 122825

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

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{27}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

V7M TEE Transducer for use with ACUSON S1000

Device Name: Intended Use: V7M TEE Transducer for use with ACUSON S1000 Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	HarmonicImaging	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P	P	Note 4
IntraoperativeAbdominal
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		P	P	Note 4
Small Organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P	P	Note 4
Trans-esophageal		P	P	P	P	P	P		P	P	Note 4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel
Laparoscopic
Musculo-skeletal(Conventional)
Musculo-skeletal(Superficial)
Other (specify)

P=previously cleared by the FDA under premarket notifications # K121138, 122825

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)

{28}------------------------------------------------

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter for use with ACUSON S1000 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
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-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P

P=Previously cleared by the FDA K121138, 122825

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) .

{29}------------------------------------------------

S1000 Ultrasound System 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter for use with ACUSON S1000 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	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify) *	Other:HarmonicImaging
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-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P

P=Previously cleared by the FDA K121138, 122825

Additional Comments:

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

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 210(k) K130619

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.