Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging functionalities and analysis packages without mentioning AI or ML. The performance studies section also indicates that clinical data was not required due to the use of existing technology, which is less common for devices incorporating novel AI/ML algorithms.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" and its intended use is to provide information "used for clinical diagnosis purposes" and "to measure anatomical structures," not to treat conditions.

Diagnostic

Yes
The device is explicitly referred to as "diagnostic ultrasound system" in the "Device Description" section and its intended use is to "provide information that is used for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system," indicating it includes hardware components for transmitting and receiving ultrasound data, in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The ACUSON NX3 and ACUSON NX3 Elite systems are diagnostic ultrasound systems. They use ultrasound waves to create images of internal anatomical structures and fluid flow within the body. This is an in vivo (within the living body) diagnostic method, not in vitro (in glass/outside the body).
Intended Use: The intended uses listed are all related to imaging various parts of the body using ultrasound. While the systems provide measurements and analysis for clinical diagnosis, this is based on the ultrasound images generated from within the body.

Therefore, the ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound Systems are diagnostic imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used 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.

Note: 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 Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

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

IYN, IYO, ITX

Device Description

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are a multi-purpose mobile, software controlled, diagnostic ultrasound system 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, 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 and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac (including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications, breast, testes, thyroid, penis, prostate.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / Not Found

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

Not Found

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

Not Found

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

Since the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.

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.

K173957

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.

Not Found

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions, USA, Inc. % Mr. Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114

October 22, 2019

Re: K192835

Trade/Device Name: ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite 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 Dated: October 1, 2019 Received: October 2, 2019

Dear Mr. Bom:

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

1

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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K192835

Device Name

ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal. Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used 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.

Note: 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 Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

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

X 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

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4

510(k) Number (if known):

Device Name:

Intended Use:

ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)	P	P	P		P	P	P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra -vascular
	Other
(Specify)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)	P	P	P	P	P	P	P
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

For example: abdominal, vascular Note 2 Note 3

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

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510(k) Number (if known):

ACUSON NX3™ Diagnostic Ultrasound System

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
Fetal	Laparoscopic
Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra -vascular
	Other
(Specify)
	Cardiac Adult	P	P	P		P	P	P
Cardiac	Cardiac Pediatric	P	P	P		P	P	P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2
Note 3 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M

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510(k) Number (if known):

| Device Name: | CH5-2 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound
System | | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | |
| Other
(Track 1
Only) | Specific
(Tracks 1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative
(Note 2) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | P | P | P | | P | P | P | |
| | SmallOrgan
(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | | P | P | P | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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510(k) Number (if known):

Device Name:

VF10-5 Linear Array Transducer for use with:

VF10-5 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application			Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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510(k) Number (if known):

Device Name:

VF12-4 Linear Array Transducer for use with:

VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic

NX3 Elite only | P | P | P | | P | P | P | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.
(Superfic) | P | P | P | | P | P | P | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
| N = new indication; P = previously cleared by (K173957) | | | | | | | | | |

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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510(k) Number (if known):

Device Name: Intended Use: EC10-5w Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P			P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	P	P	P		P	P	P
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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510(k) Number (if known):

Device Name:

EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic

NX3 Elite Only | P | P | P | | P | P | P | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | | |
| | Trans-vaginal | P | P | P | | P | P | P | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N = new indication; P = previously cleared by (K173957) | | | | | | | | | |

non-incidentally + previously cleared?) (.)

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

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Page 7 of 19

11

510(k) Number (if known):

CW2 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
	Other
(Specify)
Cardiac	Cardiac Adult			P
	Cardiac Pediatric			P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Page 8 of 19

12

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

Device Name: Intended Use:

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

Clinical Application		Mode of Operation
Other
( Track 1
Only)	Specific
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	SmallOrgan
(Note 1)
	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)
	Musculo-skel.
(Superfic)
	Intra-vascular
Other
	(Specify)
	Cardiac Adult				P
Cardiac	Cardiac Pediatric				P
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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13

510(k) Number (if known):

P4-2 Phased Sector Array Transducer for use with

P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

Device Name:

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

Clinical Application		Mode of Operation
Other
( Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	P	P	P		P	P	P
	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic

NX3 Elite Only | P | P | P | | P | P | P | | |
| | Adult Cephalic | P | P | P | | P | P | P | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Page 10 of 19

14

510(k) Number (if known):

VF16-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
Other
(Track1
Only)	Specific
(Tracks1& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P		P	P	P
	Musculo-skel.
(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Indications for Use Forms

15

510(k) Number (if known):

VF13-5sp Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Mode c Clinical Applicatio of O ati

| Other
(Track1
Only) | Specific
(Tracks1& 3) | Mode of Operation | | (Specify) |
|-----------------------------|------------- | Clinical Application | Doppler | Power
Doppler | Combined
(Note 3) | |
| Ophthalmic | Ophthalmic | | Fetal | | Abdominal | | Intra-operat (Note 2) | P | P | P | | P | | Intra-operat (Neuro) | | | | | | | Laparoscopic | Fetal
Imaging
& Other | Pediatric | P | | SmallOrgan (Specify) | | | Cardiac Adult | Cardiac | Cardiac Pediatric | | Intra-vascul (Cardiac) | | | | | | | Trans-esopha (Cardiac) | | | | | | | Intra-cardiac | | Other (Specify) | Peripheral
Vessel | Peripheral vessel
(Note 1) | P | P | P | | P | | Other (Specify) | | | | | Other
------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| B | M | PWD | CWD | Color
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
ive
| P | P | |
ive
| | | |
| | | | | | | | |
| P | P | | P | P | P | |
r/> | P | P | P | |
| | | | | | | | |
| P | P | P | | P | P | P | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |

| | | |
.
| P | P | |
.
| P | P | |
| | | | | | | | |
| | | | | | | |
| | | | | | | | |
| | | | | | | | |
ar
| | | |
geal
| | | |
| | | | | | | | |
| | | | | | | | |
| P | | |
| | | | | | | | |

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular, small parts

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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16

510(k) Number (if known):

Clinical Application Mode of Operation
Other
(Track1
Only) Specific
(Tracks1 & 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3)
Ophthalmic Ophthalmic
Fetal
Imaging
& Other Fetal P P P P P P
Abdominal P P P P P P
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Pediatric
SmallOrgan
(Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Cardiac Adult
Cardiac Pediatric
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
Vessel Peripheral vessel
Other (Specify)

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

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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17

510(k) Number (if known):

Intended Use:

C8-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name:

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal
Abdominal P P P P P P P
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal Pediatric P P P P P P P
Imaging
& Other SmallOrgan
(Note 1)
Neonatal Cephalic P P P P P P P
Adult Cephalic P P P P P P P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric P P P P P P P
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Page 14 of 19

18

510(k) Number (if known):

P8-4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use:

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal
Abdominal P P P P P P
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal
Imaging
& Other Pediatric P P P P P P
SmallOrgan
(Note 1)
Neonatal Cephalic P P P P P P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric P P P P P P
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
Vessel Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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19

510(k) Number (if known):

11L4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System /
ACUSON NX3™ Diagnostic Ultrasound System

Device Name: Intended Use:

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal
Abdominal P P P P P P
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal Pediatric P P P P P P
Imaging
& Other SmallOrgan
(Note 1) P P P P P P
Neonatal Cephalic
Adult Cephalic P P P P P P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.) P P P P P P
Musculo-skel.
(Superfic) P P P P P P
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Peripheral vessel P P P P P P
Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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20

510(k) Number (if known):

Device Name:

Intended Use:

10MC3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System /
ACUSON NX3™ Diagnostic Ultrasound System

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal P P P P P P
Abdominal
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal Pediatric
Imaging
& Other SmallOrgan
(Note 1) P P P P P P
Neonatal Cephalic P P P P P P
Adult Cephalic
Trans-rectal P P P P P P
Trans-vaginal P P P P P P
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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Page 17 of 19

21

510(k) Number (if known):

BP10-3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System /
ACUSON NX3™ Diagnostic Ultrasound System

Device Name: Intended Use:

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal
Abdominal
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal Pediatric
Imaging
& Other SmallOrgan
(Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P P P
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac)
Intra-cardiac
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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22

510(k) Number (if known):

V5Ms Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: Intended Use:

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

Clinical Application Mode of Operation
Other
( Track 1
Only) Specific
(Tracks1I& 3) B M PWD CWD Color
Doppler Power
Doppler Combined
(Note 3) Other
(Specify)
Ophthalmic Ophthalmic
Fetal
Abdominal
Intra-operative
(Note 2)
Intra-operative
(Neuro)
Laparoscopic
Fetal Pediatric
Imaging
& Other SmallOrgan
(Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph.
(non-Card.)
Musculo-skel.
(Convent.)
Musculo-skel.
(Superfic)
Intra-vascular
Other
(Specify)
Cardiac Adult
Cardiac Cardiac Pediatric
Intra-vascular
(Cardiac)
Trans-esophageal
(Cardiac) P P P P P P P
Intra-cardiac
Other (Specify)
Peripheral Peripheral vessel
Vessel Other (Specify)

N = new indication; P = previously cleared by (K173957)

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

Note 2 For example: abdominal, vascular

Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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23

510(k) Summary K192835
Date: August 25, 2019
1. Sponsor: Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person: Hyunjung Lee
Tel: (425) 281-5061
2. Device Name: ACUSON NX3 Diagnostic Ultrasound System
ACUSON NX3 Elite Diagnostic Ultrasound System
Common Name: Diagnostic Ultrasound System with Accessories
Classification: Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System 892.1550 90-IYN
Ultrasonic Pulsed Echo Imaging System 892.1560 90-IYO
Diagnostic Ultrasound Transducer 892.1570 90-ITX
Manufacturing
Facility: Siemens Healthineers Ltd.
2nd -3rd floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea

3. Legally Marketed Predicate Devices

The ACUSON NX3 Elite Diagnostic Ultrasound System and ACUSON NX3 Diagnostic Ultrasound System are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current product, ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K173957).

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4. Device Description

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are a multi-purpose mobile, software controlled, diagnostic ultrasound system 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, 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 and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

5. Intended Use/ Indications for use

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite

The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used 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.

Note: 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 Society of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine.".

6. Summary of Technological Characteristics

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products, the ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K173957). All systems transmit ultrasonic energy into patients, and then perform post processing of received echoes to generate onscreen display of anatomic

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structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

The submission devices are substantially equivalent to the predicate with regard to both intended use and technological characteristics.

| Feature / Characteristic | Predicate
Device
ACUSON
NX3TM
(K173957) | Predicate
Device
ACUSON NX3
EliteTM
(K173957) | Submission
Device
ACUSON NX3 | Submission
Device
ACUSON NX3
Elite |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------|------------------------------------|---------------------------------------------|
| Indications for Use: | | | | |
| ■ Fetal Echo | √ | √ | √ | √ |
| ■ Abdominal | √ | √ | √ | √ |
| ■ Intra-operative | - | √ | - | √ |
| ■ Neonatal Cephalic | - | √ | - | √ |
| ■ Small Organ(parts) | √ | √ | √ | √ |
| ■ Pediatric | √ | √ | √ | √ |
| ■ Adult Cephalic (Trans-
cranial) | √ | √ | √ | √ |
| ■ Cardiac (Adult) | √ | √ | √ | √ |
| ■ Cardiac (Pediatric) | √ | √ | √ | √ |
| ■ Intracardiac | - | - | - | - |
| ■ Trans-esophageal | - | √ | - | √ |
| ■ Trans-rectal | √ | √ | √ | √ |
| ■ Trans-vaginal | √ | √ | √ | √ |
| ■ Peripheral vessel | √ | √ | √ | √ |
| ■ Musculo-skeletal
(conventional) | √ | √ | √ | √ |
| ■ Musculo-skeletal
(superficial) | √ | √ | √ | √ |
| Center Frequencies
Supported: | | | | |
| ■ 2.0 MHz | √ | √ | √ | √ |
| ■ 2.5 MHz | √ | √ | √ | √ |
| ■ 3.0 MHz | √ | √ | √ | √ |
| ■ 3.5 MHz | √ | √ | √ | √ |
| ■ 4.0 MHz | √ | √ | √ | √ |
| ■ 5.0 MHz | √ | √ | √ | √ |
| ■ 5.5 MHz | √ | √ | √ | √ |
| ■ 6.0 MHz | √ | √ | √ | √ |
| ■ 6.5 MHz | √ | √ | √ | √ |
| ■ 7.5 MHz | √ | √ | √ | √ |
| ■ 8.0 MHz | √ | √ | √ | √ |
| ■ 9.0 MHz | √ | √ | √ | √ |
| ■ 10.0 MHz | √ | √ | √ | √ |
| ■ 11.0 MHz | √ | √ | √ | √ |
| ■ 12.0 MHz | - | √ | - | √ |
| ■ 13.0 MHz | - | √ | - | √ |
| Modes: | | | | |
| ■ B | √ | √ | √ | √ |
| ■ M | √ | √ | √ | √ |
| Feature / Characteristic | Predicate
Device
ACUSON
NX3TM
(K173957) | Predicate
Device
ACUSON NX3
EliteTM
(K173957) | Submission
Device
ACUSON NX3 | Submission
Device
ACUSON NX3
Elite |
| PWD (Pulsed Wave
Doppler) | √ | √ | √ | √ |
| CWD (Continuous Wave
Doppler) | - | √ | - | √ |
| SCW (Steerable CW) | √ | √ | √ | √ |
| CD (Color Doppler) | √ | √ | √ | √ |
| Amplitude Doppler
(Power Doppler) | √ | √ | √ | √ |
| Directional Power Doppler | √ | √ | √ | √ |
| Combined (BM, BC, BCM,
BCD) | √ | √ | √ | √ |
| THI (Tissue Harmonic
Imaging) | √ | √ | √ | √ |
| AMM (Anatomical M-
mode) | √ | √ | √ | √ |
| Doppler Tissue Image
(Color, PW) | √ | √ | √ | √ |
| M-THI | √ | √ | √ | √ |
| Features: | | | | |
| Multi-View Spatial
Compounding (SieClear) | √ | √ | √ | √ |
| Advanced SieClear | √ | √ | √ | √ |
| DTCE (Dynamic Tissue
Contrast Enhancement) | √ | √ | √ | √ |
| Tissue Grayscale
Optimization (TGO) | √ | √ | √ | √ |
| Dual-Beam Processing | √ | √ | √ | √ |
| Quad-Beam Processing | √ | √ | √ | √ |
| Clip Capture | √ | √ | √ | √ |
| 3D Imaging (3-Scape 3D) | √ | √ | √ | √ |
| 3D Measurements | √ | √ | √ | √ |
| 4D Basic Imaging
(fourSight 4D) | √ | √ | √ | √ |
| Panoramic 2D Imaging
(SieScape) | √ | √ | √ | √ |
| Syngo Auto OB | √ | √ | √ | √ |
| Syngo Auto Follicle | √ | √ | √ | √ |
| Cardiac Imaging
physiological signal
display
multiplane TEE
fourSight TEE Imaging | - | √ | - | √ |
| Stress Echo | √ | √ | √ | √ |
| Vascular Enhancement
(Clarify VE) | √ | √ | √ | √ |
| Syngo VVI (Velocity
Vector Image) | √ | √ | √ | √ |
| Syngo Auto Left Heart
(Auto LH) | - | √ | - | √ |
| Feature / Characteristic | Predicate
Device
ACUSON
NX3TM
(K173957) | Predicate
Device
ACUSON NX3
EliteTM
(K173957) | Submission
Device
ACUSON NX3 | Submission
Device
ACUSON NX3
Elite |
| ■ Syngo AHP | - | √ | - | √ |
| ■ Contrast Agent Image | - | √ | - | √ |
| ■ Advanced fourSight 4D | - | √ | - | √ |
| ■ DIMAQ | √ | √ | √ | √ |
| ■ Multiple Frequency
Imaging(MultiHertz) | √ | √ | √ | √ |
| ■ syngo Mitral Valve
Assessments (MVA) | - | √ | - | √ |
| ■ Digital Architecture | √ | √ | √ | √ |
| ■ HD Zoom | √ | √ | √ | √ |
| ■ Fully integrated DICOM | √ | √ | √ | √ |
| ■ Monitor: FPD | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) |
| ■ Wireless | √ | √ | √ | √ |
| ■ eSie Touch | - | √ | - | √ |
| # Channels | 64 | 64 | 64 | 64 |
| Output Display Standard
(Track 3) | √ | √ | √ | √ |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 |
| UL60601-1 Certified | √ | √ | √ | √ |

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX3 Elite™ & ACUSON NX3TM Diagnostic Ultrasound System 510(k) Submission

27

ACUSON NX3 Elite™ & ACUSON NX3™ Diagnostic 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 devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:

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 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3

트 IEC 62359:2010, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / This document and its separate amendments continue to be valid together with the consolidated version.

I Safety and EMC Requirements for Medical Equipment

O AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for O basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version

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IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General o requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: O Particular requirements for the basic safety and essential performance of endoscopic equipment

IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: Particular O requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

I ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

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

Since the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.

9. Summary

This submission expands the Indications for Use from "cardiac (including transesophageal)". The submission also adds "small parts" to the intra-operative clinical application of the VF13-5sp transducer. The cardiac (including transesophageal) clinical application was cleared in the V5Ms transducer with the predicate device. The small parts clinical application was also already cleared in the predicate device but not included in the Indications for Use of the VF13-5sp transducer. With this submission, Siemens intends to merely update the Indications for Use of the ACUSON NX3/ELITE and the Indications for Use of the VF13-5sp transducer, both of which were already cleared through the predicate. Other than the updates described in this paragraph, there has been no system or software modification to the subject device. The predicate device and subject device are the same.

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 Requlation and ISO 13485 quality system standards. The products are designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical that the ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are verified and validated according to the company's design control process.

		510(k) Summary	K192835
Date:	August 25, 2019
1. Sponsor:	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person:	Hyunjung Lee
Tel: (425) 281-5061
2. Device Name:	ACUSON NX3 Diagnostic Ultrasound System
ACUSON NX3 Elite Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology
	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
	Diagnostic Ultrasound Transducer	892.1570	90-ITX
Manufacturing
Facility:	Siemens Healthineers Ltd.
2nd -3rd floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea