Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and analysis packages without indicating advanced learning algorithms.

Therapeutic

No.

The device is described as a "diagnostic ultrasound system" intended for "clinical diagnosis purposes" and "measurement of anatomical structures," which are functions related to diagnosis, not therapy.

Diagnostic

Yes

The 'Device Description' explicitly states: "The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems". Additionally, the 'Intended Use / Indications for Use' section mentions that the systems' analysis packages "provide information that is used for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound systems" and describes hardware components like transducers and a flat panel display for image display. While it is software-controlled, it is not solely 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 are diagnostic ultrasound systems. They use sound waves to create images of internal body structures. This is an in vivo (within the living body) imaging technique, not an in vitro (in glass/outside the body) test.
Intended Use: The intended use clearly states applications for imaging various anatomical sites within the body for clinical diagnosis purposes. It does not mention analyzing samples taken from the body.
Device Description: The description focuses on the ultrasound technology, imaging modes, and display of real-time images. It does not describe any components or processes related to analyzing biological samples.

Therefore, the ACUSON NX3 and ACUSON NX3 Elite 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, 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 Parts (Small Orqan including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, 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 physicial 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 physicial with an easily understood tool for communicating with patients reqarding state of their cardiovascular system.

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 multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or 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

Ultrasound

Anatomical Site

Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal, Urology.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Nonclinical tests submitted, referenced, or relied on: acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety.
Clinical tests were not required as the devices use the same technology and principles as existing devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K152469

Reference Device(s)

K121699

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

February 1, 2018

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

Re: K173957

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: II Product Code: IYN, IYO, ITX Dated: January 26, 2018 Received: January 29, 2018

Dear Mr. Job:

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

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

Page 2 - Mr. Mark Job

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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).

Sincerely,

Michael D. O'Hara For

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

Enclosure

2

DEPARTMENTO FHEACTH AND HUMANISERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below,

510(k) Number (if known)

K173957

Device Name

ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

For ACUSON NA

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

FOT ACQUISON NEWS FITTE

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

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

The Arterial Health Package (AHP) software provides the physicial 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 physicial 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 Caroud Ultrasound to Icentify Subchical Vasular 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)

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 meintain 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid QMB_oumber."

4

510(k) Number (if known):

Device Name: Intended Use: K173957 ACUSON NX3 Elite™ Diagnostic Ultrasound System

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	P
	Abdominal	P	P	P	P	P	P	P
	Intra-operative
(Note 2)	P	P	P	P	P	P	P
	Intra-operative
(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P	P	P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P	P	P	P	P
	Neonatal Cephalic	P	P	P	P	P	P	P
	Adult Cephalic	P	P	P	P	P	P	P
	Trans-rectal	P	P	P	P	P	P	P
	Trans-vaginal	P	P	P	P	P	P	P
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	P	P	P	P	P	P	P
	Musculo-skel.
(Superfic)	P	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)	N	N	N	N	N	N	N
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P	P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K152469)

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

Note 2 For example: abdominal, vascular

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):	K173957
Device Name:	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
( 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	Pediatric	P	P	P		P	P	P
Imaging
& Other	SmallOrgan
(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic	N	N	N		N	N	N
	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 (K152469)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
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):	K173957
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	B	M	PWD	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	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	Cardiac Adult
	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 (K152469)

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):	K173957
Device Name:	VF10-5 Linear Array Transducer for use with:
ACUSON NX3 EliteTM Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound
System

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)
Fetal
Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	P	P
	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	Cardiac Adult
	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 (K152469)

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

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

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510(k) Number (if known):	K173957
---------------------------	---------

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
(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
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.)	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
Vessel	Peripheral vessel	P	P	P		P	P	P
	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

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510(k) Number (if known): K173957

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:

| 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 | | | | | | | | |
| | 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 (K152469)

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

Note 2 For example: abdominal, vascular

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):	K173957
---------------------------	---------

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
(Track1
Only)	Specific
(Tracks11& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
	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 | P | |
| | Trans-vaginal | P | P | P | P | P | P | P | |
| | 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 | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by (K152469)

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):	K173957
Device Name:	CW2 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
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
	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 (K152469)

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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510(k) Number (if known):	K173957
Device Name:	CW5 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System
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
	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)

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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510(k) Number (if known):	K173
---------------------------	------

Device Name:

3957

P4-2 Phased Sector 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
(Specify) |
|----------------------------|---------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other
( Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Note 3) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | P | P | P | P | P | P | P | |
| | Abdominal | P | P | P | P | P | P | P | |
| | Intra-operative
(Note 2) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | 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.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| | 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) | | | | | | | | |

N = new indication; P = previously cleared by (K152469)

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

Note 2 For example: abdominal, vascular

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): K173957

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
	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 (K152469)

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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510(k) Number (if known): K173957

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:

================

Clinical Application		Mode of Operation
Other
(Track1
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)	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
	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
(Note 1)	P	P	P	P	P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared by (K152469)

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):		K173957
Device Name:		C8F3 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
( 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
	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
	Other (Specify)

N = new indication; P = previously cleared by (K152469)

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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510(k) Number (if known): K173957

C8-5 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

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)
	Neonatal Cephalic	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
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 (K152469)

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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510(k) Number (if known):	K173957
---------------------------	---------

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	Pediatric	P	P	P		P	P	P
Imaging
& Other	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 (K152469)

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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Intended Use:

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):	K173957
Device Name:	11L4 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System /
ACUSON NX3™ 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
(Tracks1I& 3)	B	M	PWD	CWD	Color
Doppler	Power
Doppler	Combined
(Note 3)	Other
(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N
	Intra-operative
(Note 2)
	Intra-operative
(Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric	N	N	N		N	N	N
	SmallOrgan
(Note 1)	N	N	N		N	N	N
	Neonatal Cephalic
	Adult Cephalic	N	N	N		N	N	N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.
(non-Card.)
	Musculo-skel.
(Convent.)	N	N	N		N	N	N
	Musculo-skel.
(Superfic)	N	N	N		N	N	N
	Intra-vascular
	Other
(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular
(Cardiac)
	Trans-esophageal
(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N		N	N	N

N = new indication; P = previously cleared by

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):	K173957
Device Name:	10MC3 Transducer for use with: ACUSON NX3 Elite TM Diagnostic Ultrasound System /

ACUSON NX3TM Diagnostic Ultrasound System

Intended Use:

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

| Clinical Application | (Specify) |
|----------------------------|----------- | Other
( Track1
Only) | Specific
(Tracks11& 3) | B Doppler | Power
Doppler | Combined
(Note 3) | |
| Ophthalmic | Ophthalmic | | Fetal | | Abdominal | | Intra-oper (Note 2) | | | | | | | Intra-oper (Neuro) | | | | | | | Laparoscopic | Fetal | Pediatric | Imaging
& Other | SmallOrgan
(Note 1) | N | | Neonatal Cephalic | | Adult Cephalic | | Trans-rectal | | Trans-vaginal | | Trans-urethral | | Trans-esop (non-Card.) | | | | | Musculo-sk (Convent.) | | | | | Musculo-sk (Superfic) | | | | | Intra-vascular | | Other
(Specify) | | | Cardiac Adult | Cardiac | Cardiac Pediatric | | Intra-vasc (Cardiac) | | | | | | | Trans-esop (Cardiac) | | | | | | | Intra-cardiac | | Other (Specify) | Peripheral | Peripheral vessel | Vessel | Other (Specify) | Mode of Operation | | | | | | | Other
--------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| M | PWD | CWD | Color
| | | | | | | | |
| N | N | N | N | N | N | N | |
| | | | | | | | |
ative
| | | |
ative
| | | |
| | | | | | | | |
| | | | | | | | |
| N | N | N | N | N | N | |
| N | N | N | N | N | N | N | |
| | | | | | | | |
| N | N | N | N | N | N | N | |
| N | N | N | N | N | N | N | |
| | | | | | | | |
h.
| | | | | |
el.
| | | | | |
el.
| | | | | |
| | | | | | | | |
| | | | | | | |
| | | | | | | | |
| | | | | | | | |
ular
| | | |
hageal
| | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |

N = new indication; P = previously cleared by

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):	K173957
Device Name:	BP10-3 Transducer for use with:
ACUSON NX3 Elite" Diagnostic Ultrasound System /
ACUSON NX3" Diagnostic Ultrasound System	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	Specific

	Color
	Power
	Combined

| Other
(Track1
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 | N | N | N | N | N | N | N | |
| | 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

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

Note 2 For example: abdominal, vascular

r of Oxample: abdominar, vaooalar
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):	K173957
---------------------------	---------

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 | Mechanism |

Clinical Application		Mode of Operation
Other
( Track1
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 (K121699)

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

Note 2 For example: abdominal, vascular

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

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

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_

Page 19 of 19

23

510(k) Summary

Date:	January 23, 2018
Submitter:	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
	Mountain View, California 94043
Manufacturing
Facility:	Siemens Healthineers Ltd.
2nd -3rd floor, 143, Sunhwan-ro,
	Jungwon-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea
Contact Person:	Sulgue Choi
Tel: (425) 281-9898
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-IYC
	Diagnostic Ultrasound Transducer	892.1570	90-ITX

A. 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, the ACUSON X300PE Diagnostic Ultrasound System (K121699), ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K152469).

Primary Predicate Device(s): ACUSON NX3 and ACUSON NX3 Elite (K152469)
Reference Predicate Device: ACUSON X300PE Diagnostic Ultrasound System (K121699)

B. Device Description:

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal

24

and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

C. Intended 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 Parts (Small Orqan including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, 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 physicial 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 physicial with an easily understood tool for communicating with patients reqarding 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.".

D. Substantial Equivalence

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 X300PE Diagnostic Ultrasound System (K121699), ACUSON NX3 and ACUSON NX3 Elite Diagnostic Ultrasound System (K152469). All systems transmit ultrasonic energy into patients, and then perform post processing of received echoes to generate onscreen display of anatomic 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.

25

| Feature / Characteristic | Predicate
Device
ACUSON
X300TM
(K121699) | Predicate
Device
ACUSON
NX3TM
(K152469) | Predicate
Device
ACUSON NX3
EliteTM
(K152469) | 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 | √ | √ | √ | √ | √ | |
| ■ PWD (Pulsed Wave
Doppler) | √ | √ | √ | √ | √ | |
| ■ CWD (Continuous Wave
Doppler) | √ | - | √ | - | √ | |
| ■ SCW (Steerable CW) | √ | √ | √ | √ | √ | |
| ■ CD (Color Doppler) | √ | √ | √ | √ | √ | |
| ■ Amplitude Doppler
(Power Doppler) | √ | √ | √ | √ | √ | |
| ■ Directional Power Doppler | √ | √ | √ | √ | √ | |
| | Feature / Characteristic | Predicate
Device
ACUSON
X300TM
(K121699) | Predicate
Device
ACUSON
NX3TM
(K152469) | Predicate
Device
ACUSON NX3
EliteTM
(K152469) | Submission
Device
ACUSON NX3 | Submission
Device
ACUSON NX3
Elite |
| ■ | 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) | √ | - | - | - | √ |
| ■ | Axius EF | √ | √ | √ | √ | √ |
| ■ | 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 | √ | √ | √ | √ | √ |
| Feature / Characteristic | Predicate
Device
ACUSON
X300TM
(K121699) | Predicate
Device
ACUSON
NX3TM
(K152469) | Predicate
Device
ACUSON NX3
EliteTM
(K152469) | Submission
Device
ACUSON NX3 | Submission
Device
ACUSON NX3
Elite | |
| Monitor: FPD | (17" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | |
| ■
Wireless | √ | √ | √ | √ | √ | |
| ■
eSie Touch | - | - | √ | - | √ | |
| # Channels | 128 | 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 | Tested to ISO
10993-1 | |
| UL60601-1 Certified | √ | √ | √ | √ | √ | |

26

K173957

27

E. 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, electromagnetic and mechanical safety and have been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
트 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
트 IEC 60601-2-18:2009, Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
. CAN/CSA-C22.2 NO. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential Performance
. AIUM/NEMA UD-3:2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
트 AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
트 IEC 62359:2010, Ultrasonics – Field characterization – Test Methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
I 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
I ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

F. 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.

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G. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The 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.