Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes quantitative ultrasound measurements and calculations based on established physical principles (attenuation and backscatter coefficients) and a least squares fit to correlate these with MRI-PDFF. There is no mention of AI/ML algorithms for image analysis, pattern recognition, or decision support beyond these direct measurements and correlations.

Therapeutic

No

This device is described as a "Diagnostic Ultrasound System" intended for "imaging guidance only, not treatment delivery." Its stated purpose is to provide information for clinical diagnosis and visualization of anatomy, not to treat conditions.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly 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" section refers to it as "Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

The device is described as a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and explicitly mentions hardware components like transducers and catheter-based transducers. While it includes software updates and features, it is fundamentally a hardware-based ultrasound system with software control and analysis capabilities.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this is a diagnostic ultrasound system. Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended uses listed are all related to imaging and measurement of anatomical structures within the body. While the measurements and calculations provided by the system (like Intima Media Thickness and Quantitative Ultrasound) are used to aid in clinical diagnosis, they are derived from the ultrasound imaging data itself, not from in vitro testing of biological samples.
Device Description: The device description focuses on the technical aspects of the ultrasound system, including its modes of operation and transducers.
Performance Studies: The performance studies described involve phantom studies and a clinical study where measurements were taken directly from the liver of participants using the ultrasound system and compared to MRI-PDFF measurements. This further reinforces that the device operates in vivo, not in vitro.

Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

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

IYN, IYO, ITX, OBJ

Device Description

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative, Pediatric, Small Parts (breast, testes, thyroid, penis, prostate), Transcranial, OB/GYN (ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Transesophageal, Transrectal, Transvaginal, Intra-cardiac, Intra-luminal (cardiac and great vessel). The Quantitative Ultrasound (QUS) software measures the attenuation and backscatter coefficient in a 3-cm by 3-cm region of interest in the liver.

Indicated Patient Age Range

Adult and pediatric patients.

Intended User / Care Setting

Clinician, Physician

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

Not Found

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

Phantom Study: The accuracy and precision of the device was obtained based on tests performed on phantoms with known attenuation and backscatter coefficients. The overall range of values of AC and BSC are within +/-20% of the nominal values of the phantoms.

Clinical Study: Acoustic property measurements including the AC and BSC were obtained from the liver of one hundred and one (101) participants in an external clinical study. The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements.

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

Phantom Study: The accuracy and precision of the device was obtained based on tests performed on phantoms with known attenuation and backscatter coefficients. The overall range of values of AC and BSC are within +/-20% of the nominal values of the phantoms.
Clinical Study: Acoustic property measurements including the AC and BSC were obtained from the liver of one hundred and one (101) participants in an external clinical study. The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements.
The results of the clinical study indicate that BMI does not have a statistically significant effect on measurements of the AC and BSC. Patients with lower steatosis grade had lower values of UDFF and MRI-PDFF, and patients with higher steatosis grade had larger values of UDFF and MRI-PDFF.
The trends for patients with less than 5% MRI-PDFF scores (steatosis grade S0) and with more than 30% MRI-PDFF scores (steatosis grade S3) were not clear given the small number of samples in these ranges.

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.

K172162, K131164

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.

K181547, K103411

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

March 20, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Siemens Healthineers % Ms. Christine Dunbar Sr. Regulatory Affairs Specialist 22010 SE 51 Street ISSAQUAH WA 98029

Re: K183575

Trade/Device Name: ACUSON S3000, S2000 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, OBJ Dated: February 17, 2019 Received: February 19, 2019

Dear Ms. Dunbar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

1

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Michael D'Hara For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183575

Device Name

ACUSON S3000, S2000 Diagnostic Ultrasound System

Indications for Use (Describe)

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

The Transducer Indications for Use on the attached pages.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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Page 31 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11,13
Abdominal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6, 7,8,10,11,
13,16,17,18,20,21
Intraoperative
(Note 9)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11,14
Intraoperative
Neurological		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11,14
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6,7,8,10,11
Small Organ
(Note 1)		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6, 7,8,10,
11,14,16,18,19,20
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Cardiac		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,15
Trans-esophageal		P	P	P	P	P	P	BMDC	Note 4
Transrectal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,6, 7,8,10,
11,14
Transvaginal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10,11
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,15
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10, 11,14
Musculo-skeletal
Superficial		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10, 11,14
Other (specify)
Neonatal cardiac		P	P	P	P	P	P	BMDC	Note 3,4,10,17

N = new indication; P = previously cleared by K172162; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)

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

Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
For example: vascular, abdominal Note 9 Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 20 VTQ
Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE technology Note 13 STIC Note 15 AHP Note 17 eSie Fusion
Ensemble tissue harmonic imaging Tissue Equalization Technology
Note 19 VTIQ
Note 2

Note 4

Note 21 QUS (Quantitative Ultrasound)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices

510(k)_

02.17.2019

5

510 (k) Number (if known):

Device Name:	CW2 Probe
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

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

For example: vascular, abdominal Note 9

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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-----------------------------------------------------------

510(k)
--------	--

6

510 (k) Number (if known):

Device Name:	CW5 Probe
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal					P
Abdominal					P
Intraoperative
(Note 9)					P
Intraoperative
Neurological					P
Pediatric					P
Small Organ
(Note 1)					P
Neonatal Cephalic					P
Adult Cephalic					P
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional					P
Musculo-skeletal
Superficial					P
Other (specify)

N = new indication; P = previously cleared by FDA K172162

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)

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Page 34 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name:		EC9-4 Curved Array Transducer
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P	BMDC	Note
2,3,4,5,6,7,8,10,11,17
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,11,14
Neonatal Cephalic		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
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 K172162

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

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

Note 17 eSie™ Fusion

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Page 35 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | 9L4 Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 | |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 6,18,20 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,11 | |
| Small Organ
(Note 1) | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,6,7,8,10,11,14,16,18,
19,20 | |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 | |
| Adult Cephalic | P | P | P | P | | P | P | | | | |
| Cardiac | P | P | P | P | | P | P | | BMDC | Note 15 | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14,15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Musculo-skeletal
Superficial | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

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 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 16 Custom Tissue Imaging

Note 19 VTIQ

Note 2 Ensemble tissue harmonic imaging

Note 4

te 6 Cadence contrast agent imaging

te 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear

Note 15 AHP

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

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510(k)

Tissue Equalization Technology
Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 18 VTI Note 20 VTQ

9

510 (k) Number (if known):

Device Name: Intended Use:

14L5BV Multi-D Array Transducer for use on 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
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,
16
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K081148

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Ensemble tissue harmonic imaging Note 2
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 imaqinq Note 7
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

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

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10

510 (k) Number (if known):

| Device Name:
Intended Use: | | 4P1 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---|--------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| 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 | |
| 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 K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq

Note 3 SieClear multi-view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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

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11

Page 38 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: Intended Use:

6C2 Curved Array Transducer

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

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

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq
Tissue Equalization Technology Note 4

B&W SieScape panoramic imaqinq Note 7

Note 10 Clarify VE vascular enhancement technology

Note 14 eSie™ Touch elasticity imaging / FTI

Note 17 eSie Fusion

Note 3 SieClear multi-view spatial compounding

3-Scape real-time 3D imaging Note 5

Power SieScape panoramic imaqinq Note 8

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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510 (k) Number (if known):

| Device Name: | 4C1 Curved Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------------|
| Intended Use: | | | | | | | | | | |
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,18,
19,20 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note
2,3,4,5,6,7,8,10,11,1
4,16,17 |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | | Note 6 |
| Small Organ | | P | P | P | P | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 20 VTQ
SieClear multi-view spatial compounding Note 3
Note 5 3-Scape real-time 3D imaginq
B&W SieScape panoramic imaging Note 7
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 19 VTIQ

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

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13

Page 40 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

| Device Name:
Intended Use: | 6C1HD Curved Array Transducer HD
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------------------------|--|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note
2,3,4,5,7,8,10,11 | |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note
2,3,4,5,6,7,8,10,11,1
4,16,17,18,19,20,21 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 6 | |
| Small Organ | P | P | P | P | P | P | P | | BMDC | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 20 VTQ
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
Note 17 eSie Fusion
Note 19 VTIQ

Note 21 QUS (Quantitative Ultrasound)

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

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14

510 (k) Number (if known):

Device Name:	8C3HD Curved Array Transducer for use with ACUSON S3000
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,
16
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11
Small Organ		P	P	P		P	P	BMDC
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging

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

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15

510 (k) Number (if known):

Device Name:	4V1 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,14,16,
17,18,19,20
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

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 17 eSie Fusion

Note 19 VTIQ
Note 3 SieClear multi view spatial compounding
Note 5 3-Scape real-time 3D imaging

Power SieScape panoramic imaging Note 8

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging
Note 18 VTI Note 20 VTQ

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510(k)_

02.17.2019

16

510 (k) Number (if known):

| Device Name:
Intended Use: | 10V4 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | P | 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 | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | 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 K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaqinq

Note 3 SieClear multi view spatial compounding

Tissue Equalization Technology Note 4

Note 5 3-Scape real-time 3D imaging

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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510(k)

17

510 (k) Number (if known):

Device Name:	14L5 SP Linear Array Transducer
Indications For Use:		Diagnostic imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
(Note 9)		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10
Intraoperative
Neurological		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11
Pediatric
Small Organ
(Note 1)		P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,
16
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	BMDC	Note 15
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC	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
Other (specify)

N = new indication; P = previously cleared by FDA K172162

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 7 B&W SieScape panoramic imaqing

Note 8 Power SieScape panoramic imaging

For example: vascular, abdominal Note 9

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 14 eSie™ Touch elasticity imaging / FTI

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Note 15 AHP Note 16 Custom Tissue Imaging

Page 14 of 26

02.17.2019

18

510 (k) Number (if known):

| Device Name:
Intended Use: | | 7CF2 Curved array mechanical 3D transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|---|-----------------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------|--|--|
| | | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,13 | | |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,13 | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

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 imaqinq

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

Note 11 Advanced Sieclear spatial compounding

Note 13 STIC

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

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19

Page 46 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

9EVF4 Curved Array Transducer

Device Name: Intended Use:

Fetal

Abdominal

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

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

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

N = new indication; P = previously cleared by FDA K172162

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

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 13 STIC

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20

510 (k) Number (if known):

| Device Name:
Intended Use: | V5Ms Multiplane TEE Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | P | P | P | P | P | P | P | P | BMDC | Note 4 |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 4 Tissue Equalization Technology

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510 (k) Number (if known):

Device Name:	18L6 HD Linear Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)	P	P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,
16
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P		P	P	BMDC	Note 15
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14,
15
Laparoscopic
Musculo-skeletal
Conventional	P	P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14
Musculo-skeletal
Superficial	P	P	P	P		P	P	BMDC	Note
2,3,4,5,7,8,10,11,14
Other (specify)

N = new indication; P = previously cleared by FDA K172162

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

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
Note 14 eSie™ Touch elasticity imaging / FTI

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Note 15 AHP Note 16 Custom Tissue Imaging

02.17.2019

22

510 (k) Number (if known):

Device Name: Intended Use: 8V3 Phased Array Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	BMDC	Note 2,3,4,5,7,8,10
Adult Cephalic
Cardiac		P	P	P	P	P	P	BMDC	Note 3,4
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

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

B&W SieScape panoramic imaging Note 7

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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23

510 (k) Number (if known):

| Device Name:
Intended Use: | 4V1c Phased Array Transducer
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 | | 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 K172162

Additional Comments:

Note 2 Ensemble tissue harmonic imaging

Note 3 SieClear multi-view spatial compounding

Note 4 Tissue Equalization Technology

Note 5 3-Scape real-time 3D imaging

Note 6 Cadence contrast agent imaging

Note 7 B&W SieScape panoramic imaging

Power SieScape panoramic imaging Note 8

Note 10 Clarify VE vascular enhancement technology

Note 15 AHP

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510 (k) Number (if known):

| Device Name:
Intended Use: | EV8C4 Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|--|
| | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note
2,3,4,5,6,7,8,10 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

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

Note 7 B&W SieScape panoramic imaging

Note 8 Power SieScape panoramic imaging

Note 10 Clarify VE vascular enhancement technology

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Page 52 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

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

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

N = new indication; P = previously cleared by FDA K172162

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

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510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 8F Ultrasound Catheter

›uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

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

P=Previously cleared by the FDA K172162

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,

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510 (k) Number (if known):

Device Name: Intended Use:

AcuNav 10F Ultrasound Catheter ›uCatheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

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

P=Previously cleared by the FDA K172162

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,

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Diagnostic Ultrasound Indications for Use Form

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

MC9-4 Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,11
Abdominal		P	P	P		P	P	BMDC	Note 2,3,4,5,7,8,10,11
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (note

     |                   | 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
2,3,4,5,7,8,10,11,14 |
| 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 K172162

Additional Comments:

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

Note 3 SieClear multi-view spatial compounding

Siescape real-time 3D imaging Note 5

B&W SieScape panoramic imaging Note 7

Note 10 Clarify VE Vascular enhancement technology

Note 14 eSie Touch elasticity imaging/FTI

Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

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Page 56 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS

Diagnostic Ultrasound Indications for Use Form

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

14L5 Transducer

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (note

     | P                 | P | P | P   |     | P                | P                    |                              | BMDC                  | Note

2,3,4,5,7,8,10,11,14,
16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,6,7,8,10,11,14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | P | P | P | P | | P | P | | BMDC | Note
2,3,4,5,7,8,10,11,14 |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = new indication; P = previously cleared by FDA K172162

Additional Comments:

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

Note 3 SieClear multi-view spatial compounding

Note 5 Siescape 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

Note 2 For example: vascular, abdominal
Note 4 Tissue Equalization Technology

Note 6 Cadence contrast agent imaging

Note 8 Power SieScape panoramic imaging

Note 11 Advanced Sieclear spatial compounding

Note 16 Custom Tissue Imaging

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30

| 510(k) Summary
Prepared December 16, 2018

Updated February 17, 2019
Sponsor:	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person:	Christine Dunbar
Tel: (925) 374-2045
Device Name:	ACUSON S3000TM, S2000TM Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:
Review Category:
Classification Panel:	II
Tier II
90, Radiology
	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYC
	Diagnostic Ultrasound Transducer	892.1570	90-ITX
	Diagnostic Intravascular Catheter	892.1200	90-OB

Legally Marketed Predicate Devices 3.

The modified ACUSON S3000, S2000 Diagnostic Ultrasound Systems are substantially equivalent to the company's own ACUSON S3000, S2000 and S1000 system cleared under K172162, which is the primary predicate device.

The second predicate is the Siemens Virtual Touch Quantification (VTQ) feature, as currently cleared under K131164. The VTQ software under modification includes the new Quantitative Ultrasound (OUS) feature.

The Echosens Fibroscan system with Controlled Attenuation Parameter (CAP) for measurements of the ultrasound coefficient of attenuation serves as a reference predicate system, specifically for QUS measurements of the Attenuation Coefficient (AC).

The second reference predicate is the GE IDEAL Software for magnetic resonance imaging proton density fat fraction (MRI-PDFF). The Ultrasonically-derived Fat Fraction (UDFF)

SIEMENS Healthineers 02.17.2019

31

index provides a clinical utility similar to that of MRI-PDFF as an aid for managing patients with hepatic steatosis.

Device Description 4.

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

5. Intended Use

The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

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

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

The AcuNav 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. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (QUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm by 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region

32

of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

6. Summary of Technological Characteristics

The ACUSON S2000 and S3000 Diagnostic Ultrasound Systems with software version VE11A are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to the company's own products, the ACUSON S1000, 2000 and S3000 VE10A (K172162) and the ACUSON S2000 and S3000 (K131164 with VTQ feature) with regard to both intended use and technological characteristics.

The subject ultrasound systems and the currently cleared primary predicate ultrasound systems function in the same manner and with the same list of transducers including cardiac catheters.

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

The ACUSON S2000 and S3000 with software version VE11A are substantially equivalent to the predicate devices with regard to both intended use, indications for use and technological characteristics. The table below compares the technological characteristics between the submission device and the predicated devices.

| Feature / Characteristic | Submission
Device | Primary
Predicate
K172162 | Secondary
Predicate
K131164
(VTQ) | Reference
Predicate
Fibroscan
K181547 | Reference
Predicate
GE MR
IDEAL
K103411 |
|------------------------------------------------------------|----------------------------------------------------|---------------------------------|--------------------------------------------|------------------------------------------------|-----------------------------------------------------|
| Indications for Use | | | | | |
| ■ Fetal | ✓ | ✓ | ✓ | - | - |
| ■ Abdominal | ✓ | ✓ | ✓ | ✓ | - |
| ■ Intraoperative abdominal
and vascular | ✓ | ✓ | ✓ | - | - |
| ■ Intraoperative neurological | - | - | - | - | - |
| ■ Pediatric | ✓ | ✓ | ✓ | - | - |
| ■ Small Organ | ✓ | ✓ | ✓ | - | - |
| ■ Neonatal cephalic | ✓ | ✓ | ✓ | - | - |
| ■ Adult Cephalic | ✓ | ✓ | ✓ | - | - |
| ■ Cardiac | ✓ | ✓ | ✓ | - | - |
| Feature / Characteristic | Submission
Device | Primary
Predicate
K172162 | Secondary
Predicate
K131164
(VTQ) | Reference
Predicate
Fibroscan
K181547 | Reference
Predicate
GE MR
IDEAL
K103411 |
| ■ Trans-esophageal | ✓ | ✓ | ✓ | - | - |
| ■ Transrectal | ✓ | ✓ | ✓ | - | - |
| ■ Transvaginal | ✓ | ✓ | ✓ | - | - |
| ■ Peripheral vessel | ✓ | ✓ | ✓ | - | - |
| ■ Laparoscopic | - | - | -- | - | - |
| ■ Musculo-skeletal
(conventional) | ✓ | ✓ | ✓ | - | - |
| ■ Musculo-skeletal
(superficial) | ✓ | ✓ | ✓ | - | - |
| Center Frequencies Supported | | | | | |
| ■ 2.0 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 2.5 MHz | - | - | - | - | - |
| ■ 3.0 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 3.2 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 3.3 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 3.5 MHz | - | - | - | ✓ | - |
| ■ 4.2 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 4.4 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 4.8 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 5.0 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 5.2 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 6.0 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 6.5 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 6.9 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 9.5 MHz | ✓ | ✓ | ✓ | - | - |
| ■ 10.0 MHz | ✓ | ✓ | ✓ | - | - |
| Modes | | | | | |
| ■ B | ✓ | ✓ | ✓ | - | - |
| ■ Parallel processing in B
mode | ✓ | ✓ | ✓ | - | - |
| ■ M | ✓ | ✓ | ✓ | - | - |
| Feature / Characteristic | Submission
Device | Primary
Predicate
K172162 | Secondary
Predicate
K131164
(VTQ) | Reference
Predicate
Fibroscan
K181547 | Reference
Predicate
GE MR
IDEAL
K103411 |
| ■ PWD (Pulsed Wave
Doppler) | ✓ | ✓ | ✓ | - | - |
| ■ CWD (Continuous Wave
Doppler) | ✓ | ✓ | ✓ | - | - |
| ■ D (Color Doppler) | ✓ | ✓ | ✓ | - | - |
| ■ Amplitude Doppler | ✓ | ✓ | ✓ | ✓ | - |
| ■ Combined (BMDC) | ✓ | ✓ | ✓ | - | - |
| Features | | | | | |
| Quad processing in color | ✓ | ✓ | ✓ | - | - |
| ■ Native™ tissue harmonic
imaging | ✓ | ✓ | ✓ | - | - |
| ■ SieScape™ panoramic
imaging | ✓ | ✓ | ✓ | - | - |
| ■ Color SieScape™
panoramic imaging | ✓ | ✓ | ✓ | - | - |
| ■ 3-Scape™ real-time 3D
imaging | ✓ | ✓ | ✓ | - | - |
| ■ fourSight™ 4D transducer
technology | ✓ | ✓ | ✓ | - | - |
| ■ TEQ™ ultrasound
technology | ✓ | ✓ | ✓ | - | - |
| ■ Cardiac Imaging
physiological signal display | ✓ | ✓ | ✓ | - | - |
| ■ syngo ® Auto OB
measurements | ✓ | ✓ | ✓ | - | - |
| ■ Advanced SieClear™
spatial compounding | ✓ | ✓ | ✓ | - | - |
| ■ STIC (Fetal Heart Imaging) | ✓ | ✓ | ✓ | - | - |
| ■ Amnioscopic rendering | ✓ | ✓ | ✓ | - | - |
| ■ Cadence contrast agent
imaging | ✓ | ✓ | ✓ | - | - |
| ■ Contrast Dynamics | ✓ | ✓ | ✓ | - | - |
| ■ Clarify™ vascular
enhancement technology | ✓ | ✓ | ✓ | - | - |
| ■ eSie™ Touch elasticity
imaging | ✓ | ✓ | ✓ | - | - |
| Feature / Characteristic | Submission Device | Primary Predicate K172162 | Secondary Predicate K131164 (VTQ) | Reference Predicate Fibroscan K181547 | Reference Predicate GE MR IDEAL K103411 |
| syngo ® Auto Left heart | Tested to ISO 10993-1 | Tested to ISO 10993-1 | ✓ | - | - |
| syngo ® Velocity Vector Imaging | ✓ | ✓ | ✓ | - | - |
| Semi Auto-segmentation (eSie Calc) | ✓ | ✓ | ✓ | - | - |
| Custom Tissue Imaging / Speed of Sound | ✓ | ✓ | ✓ | - | - |
| Virtual Touch Imaging (VTI) (S2000, S3000) | ✓ | ✓ | - | - | - |
| Virtual Touch Quantification (VTQ) (S2000, S3000) | ✓ | ✓ | ✓ | Shear wave Speed | - |
| Virtual Touch Imaging Quantification (VTIQ) (S2000, S3000) | ✓ | ✓ | - | - | - |
| Quantitative Ultrasound (QUS) | New | - | - | ✓ | - |
| AC | AC at 3.0 MHz | - | - | CAP at 3.5 MHz | - |
| BSC | BSC at 3.0 MHz | - | - | - | - |
| UDFF Index | Index based on acoustic physical tissue properties | - | - | - | MRI Proton Density Fat Fraction (MRI-PDFF) |
| AHP | ✓ | ✓ | ✓ | - | - |
| Monitor: 19" FPD | ✓ | ✓ | ✓ | - | - |
| eSie Fusion | ✓ | ✓ | - | - | - |
| Output Display Standard (Track 3) | ✓ | ✓ | ✓ | ✓ | - |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | Tested to ISO 10993-1 | - | - |
| UL 60601-1 Certified | ✓ | ✓ | ✓ | - | - |

Table 1: Comparison of Technological Characteristics

Image /page/32/Picture/10 description: The image shows the Siemens Healthineers logo and the date 02.17.2019. The Siemens logo is in teal, and the Healthineers logo is in orange. The date is in black and is located below the logos. The Siemens Healthineers logo is a well-known logo in the medical technology industry.

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Healthineers
02.17.2019

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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, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards.

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

The ACUSON S2000 and S3000 Ultrasound systems comply with the following standards:

UL 60601-1:2006, Medical electrical equipment, Part 1: General requirements for safety .
IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements For Basic ● Safety And Essential Performance (IEC 60601-1:2005, (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)
IEC 60601-1-2: 2007(Third Edition), Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-37:2007+A1:2015, Medical electrical equipment Part 2-37: Particular ● requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment. IEC 60601-2-18 Medical electrical equipment - part 2-18: particular requirements for basic safety and essential performance of endoscopic equipment.
AIUM/NEMA UD-3:2004. Standard for Real Time Display of Thermal and Mechanical ● Acoustic Output Indices on Diagnostic Ultrasound Equipment.
AIUM/NEMA UD-2:2004. Acoustic Output Measurement Standard for Diagnostic ● Ultrasound Equipment.
ISO 10993-1:2009, Biological evaluation of Medical Devices ●
IEC 62366:2014, Medical Devices Application of Usability ●
IEC 62359:2010, Ultrasonics Field characterization Test Methods for the ● determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

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

Phantom Study: The accuracy and precision of the device was obtained based on tests performed on phantoms with known attenuation and backscatter coefficients. The overall range of values of AC and BSC are within +/-20% of the nominal values of the phantoms.

Clinical Study: Acoustic property measurements including the AC and BSC were obtained from the liver of one hundred and one (101) participants in an external clinical study. The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements.

Table 2 summarizes baseline demographic information from the clinical study including sex, age, BMI, race, and ethnicity. There were no adverse effects or complications in the

Image /page/36/Picture/21 description: The image shows the Siemens Healthineers logo in teal and orange. The logo is followed by the date 02.17.2019 in black font. The Siemens logo is in teal, while the Healthineers logo is in orange.

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acquisition of the ultrasound clinical data. The QUS software has identical safety considerations as compared to conventional ultrasound B-mode imaging.

Characteristic	Value
Sex
Male	39 of 101 (39)
Female	62 of 101 (61)
Age
mean ± SD	$52.02\pm13.5$
Range	19-74
BMI
mean ± SD	$30.6\pm5.1$
Range	17.6-43.3
Racial Category
White	50 of 101 (49)
Black	2 of 101 (2.0)
Asian	12 of 101 (12)
American Indian	1 of 101 (1.0)
Hawaiian or Pacific Islander	1 of 101 (1.0)
Unknown	35 of 101 (35)
Ethnic Category
Hispanic/Latino	39 of 101 (39)
Non-Hispanic	60 of 101 (59)
Other	2 of 101 (2)
Steatosis Grade
0; 66% hepatocytes	12 of 90 (13)
MRI-PDFF (%)
mean ± SD	$13.8\pm8.9$
Range	0.6-40.6

Table 2:Participant Characteristics

Note: Numbers in parentheses are percentages.

The results of the clinical study indicate that BMI does not have a statistically significant effect on measurements of the AC and BSC. Patients with lower steatosis grade had lower values of UDFF and MRI-PDFF, and patients with higher steatosis grade had larger values of UDFF and MRI-PDFF.

The trends for patients with less than 5% MRI-PDFF scores (steatosis grade S0) and with more than 30% MRI-PDFF scores (steatosis grade S3) were not clear given the small number of samples in these ranges.

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Reference Studies: In addition to the phantom and external clinical studies, peer-reviewed journal articles in studies utilizing Siemens ACUSON S3000 Diagnostic Ultrasound Systems were used to support the claim for the safety and effectiveness of quantitative ultrasound for assessing hepatic steatosis. The references below offer further reading on the performance of quantitative ultrasound.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance.

The S2000 and S3000 Diagnostic ultrasound systems have accumulated a long history of safe and effective performance. The software modification of the S2000 / S3000 Diagnostic Ultrasound VTQ feature raises no new issues of safety and effectiveness.

Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON S2000 and S3000 systems including the new Quantitative Ultrasound (QUS) feature is substantially equivalent with respect to safety and effectiveness to the currently cleared predicate devices for the U.S. market.

10. References

[1] S. C. Lin, E. Heba, T. Wolfson, B. Ang, A. Gamst, A. Han, J. W. Erdman, W. D. O' Brien, M. P. Andre, C. B. Sirlin and others, "Noninvasive diagnosis of nonalcoholic fatty liver disease and quantification of liver fat using a new quantitative ultrasound technique," Clinical Gastroenterology and Hepatology, vol. 13, pp. 1337-1345, 2015.
[2] J. S. Paige, G. S. Bernstein, E. Heba. E. A. C. Costa, M. Fereirra. T. Wolfson, A. C. Gamst, M. A. Valasek, G. Y. Lin, A. Han and others, "A Pilot Comparative Study of Quantitative Ultrasound, Conventional Ultrasound, and MRI for Predicting Histology-Determined Steatosis Grade in Adult Nonalcoholic Fatty Liver Disease," American Journal of Roentgenology, vol. 208, pp. W168--W177, 2017.
[3] A. Han, M. P. Andre, J. W. Erdman, R. Loomba, C. B. Sirlin and W. D. O'Brien, "Repeatability and Reproducibility of a Clinically Based QUS Phantom Study and Methodologies," IEEE transactions on ultrasonics, ferroelectrics, and frequency control, vol. 64, pp. 218-231, 2017.
[4] A. Han, Y. Labyed, M. P. Andre, J. W. Erdman, R. Loomba, C. B. Sirlin and W. D. O'Brien, "Inter-sonographer Reproducibility of Quantitative Ultrasound Outcomes and Shear Wave Speed Measured in the Right Lobe of the Liver in Adults with Known or Suspected Nonalcoholic Fatty Liver Disease," Accepted for publication in European Radiology, 2018.

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