ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System

• K Number: K173957
• Device Name: ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
• Manufacturer: Siemens Medical Solutions USA, Inc.
• Date Cleared: 2018-02-01 ( 35 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K121699 , K152469
• Predicate For: K192835

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.".

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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification from Siemens Medical Solutions USA, Inc. for their ACUSON NX3 Diagnostic Ultrasound System and ACUSON NX3 Elite Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a de novo clinical study.

Therefore, the document does not contain information on acceptance criteria and specific study details for proving device performance in the way a clinical trial submission would. Instead, it highlights the safety and performance aspects by demonstrating adherence to recognized standards and substantial equivalence to previously cleared devices.

Here's an analysis of the information available in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance in the typical sense of a clinical outcome study. Instead, it demonstrates performance by:

• Indications for Use: Listing the clinical applications for which the device is intended (e.g., Fetal, Abdominal, Pediatric, Cardiac, Vascular, etc.).
• Operating Modes: Stating the various imaging and Doppler modes available (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Power Doppler, Combined modes).
• Supported Frequencies: Listing the range of center frequencies supported by the transducers.
• Features: Enumerating various proprietary features (e.g., Multi-View Spatial Compounding, Syngo Auto OB, Stress Echo, DICOM integration).
• Compliance with Standards: Stating conformance with various international and national standards for medical electrical equipment, acoustic output, and biological evaluation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "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."

Therefore, no clinical test set was used for a primary clinical effectiveness study, and thus no sample size, data provenance (country, retrospective/prospective), or ground truth establishment details are present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

As no clinical data was required or submitted, there is no information regarding experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Since no clinical data was required or submitted, there is no information on any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported, and thus no effect size related to human reader improvement with AI assistance is mentioned.

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

This is not applicable as the device is a diagnostic ultrasound system and not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No clinical ground truth data specific to this submission was used or referenced, as clinical data was not required for substantial equivalence. The "ground truth" for demonstrating safety and performance relies on engineering verification, validation against internal specifications, and compliance with recognized standards.

8. The sample size for the training set

This is not applicable, as the submission does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as the submission does not describe an AI/ML device that requires a training set.

---

Summary of what the document does provide in relation to acceptance criteria and performance:

The document outlines an argument for Substantial Equivalence based on:

• Identical Intended Use: The ACUSON NX3 and NX3 Elite systems share the same intended uses as their predicate devices (ACUSON X300PE (K121699), and previous ACUSON NX3 and NX3 Elite (K152469)). The new indications for specific transducers (marked 'N' in the detailed intended use tables) are presented as extensions to existing cleared technology, not requiring new clinical performance studies.
• Similar Technological Characteristics: The submission device utilizes similar fundamental technological characteristics (e.g., ultrasonic energy transmission, post-processing for display, specialized measurements) as the predicate devices. Differences in features (e.g., specific frequencies supported by new transducers, absence/presence of certain advanced features across models) are compared in a table (pages 25-26) to demonstrate that these differences do not raise new questions of safety or effectiveness.
• Compliance with Safety Standards: The devices have been evaluated and found to conform with applicable medical device safety standards, including:
  • AAMI / ANSI ES60601-1 (general medical electrical equipment safety)
  • IEC 60601-2-37 (ultrasound medical diagnostic equipment specific safety)
  • IEC 60601-2-18 (endoscopic equipment safety - if applicable)
  • CAN/CSA-C22.2 NO. 60601-1
  • AIUM/NEMA UD-3 and UD-2 (acoustic output standards)
  • IEC 62359 (test methods for thermal and mechanical indices)
  • IEC 60601-1-2 (electromagnetic compatibility)
  • ISO 10993-1 (biological evaluation of medical devices)
• Verification and Validation: The products are designed to conform with applicable medical device safety standards, and compliance is verified through independent evaluation with ongoing factory surveillance. The systems are "verified and validated according to the company's design control process." (Page 28)

In the context of this 510(k), the "acceptance criteria" are implied by the requirements for substantial equivalence and compliance with these recognized safety and performance standards. The "study that proves the device meets the acceptance criteria" is the comprehensive engineering and safety testing performed to ensure the device operates as intended and meets the regulatory standards, along with the comparison to legally marketed predicate devices. No new clinical performance study was deemed necessary by the FDA for this particular submission.

Summary

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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);

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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 ([e-mail]) or phone [phone] 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

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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.

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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.

(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 1 of 19

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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

(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 2 of 19

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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	CWD	Color Doppler	Power Doppler	Combined (Note 3)	Other (Specify)
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	Peripheral vessel	P	P	P		P	P	P
	Other (Specify)

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

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)

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

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

Page 3 of 19

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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 UltrasoundSystem

Intended Use:

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

Clinical Application		Mode of Operation
Other(Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	OphthalmicFetal
	Abdominal	P	P	P		P	P	P
	Intra-operative(Note 2)
	Intra-operative(Neuro)
FetalImaging& 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)
PeripheralVessel	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

(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 4 of 19

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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(Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& 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)
PeripheralVessel	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

(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 5 of 19

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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

(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 6 of 19

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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(Track1Only)	Specific(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal	P	P	P		P	P	P
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
	PediatricSmallOrgan(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

(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 7 of 19

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& 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)
PeripheralVessel	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)

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

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

Page 8 of 19

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& 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)
PeripheralVessel	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)

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

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

Page 9 of 19

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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)
PeripheralVessel	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

(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)_

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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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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)

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

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

Page 11 of 19

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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(Track1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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

(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 12 of 19

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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 UltrasoundSystem
Intended Use:	Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
Other( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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
FetalImaging& 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)
PeripheralVessel	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)

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

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

Page 13 of 19

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

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( Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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)
PeripheralVessel	Peripheral vesselOther (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)

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

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

Page 14 of 19

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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 1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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)
PeripheralVessel	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)

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

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

Page 15 of 19

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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 1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& 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

(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 16 of 19

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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		Mode of Operation							Other(Specify)
Other( Track1Only)	Specific(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)	N	N	N	N	N	N	N
	Neonatal Cephalic	N	N	N	N	N	N	N
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	N
	Trans-vaginal	N	N	N	N	N	N	N
	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

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)

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

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

510(k)_

Page 17 of 19

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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(Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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

(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 18 of 19

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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( Track1Only)	Specific(Tracks1I&3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	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)_

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510(k) Summary

Date:	January 23, 2018
Submitter:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield Road
	Mountain View, California 94043
ManufacturingFacility:	Siemens Healthineers Ltd.2nd -3rd floor, 143, Sunhwan-ro,
	Jungwon-gu, Seongnam-si, Gyeonggi-do,Republic of Korea
Contact Person:	Sulgue ChoiTel: [phone]
Device Name:	ACUSON NX3 Diagnostic Ultrasound SystemACUSON NX3 Elite Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:IIReview Category:Tier IIClassification 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.

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Feature / Characteristic	PredicateDeviceACUSONX300TM(K121699)	PredicateDeviceACUSONNX3TM(K152469)	PredicateDeviceACUSON NX3EliteTM(K152469)	SubmissionDeviceACUSON NX3	SubmissionDeviceACUSON NX3Elite
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 FrequenciesSupported:
■ 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 WaveDoppler)	√	√	√	√	√
■ CWD (Continuous WaveDoppler)	√	-	√	-	√
■ SCW (Steerable CW)	√	√	√	√	√
■ CD (Color Doppler)	√	√	√	√	√
■ Amplitude Doppler(Power Doppler)	√	√	√	√	√
■ Directional Power Doppler	√	√	√	√	√
	Feature / Characteristic	PredicateDeviceACUSONX300TM(K121699)	PredicateDeviceACUSONNX3TM(K152469)	PredicateDeviceACUSON NX3EliteTM(K152469)	SubmissionDeviceACUSON NX3	SubmissionDeviceACUSON NX3Elite
■	Combined (BM, BC, BCM,BCD)	√	√	√	√	√
■	THI (Tissue HarmonicImaging)	√	√	√	√	√
■	AMM (Anatomical M-mode)	√	√	√	√	√
■	Doppler Tissue Image(Color, PW)	√	√	√	√	√
■	M-THI	√	√	√	√	√
	Features:
■	Multi-View SpatialCompounding (SieClear)	√	√	√	√	√
■	Advanced SieClear	-	√	√	√	√
■	DTCE (Dynamic TissueContrast Enhancement)	√	√	√	√	√
■	Tissue GrayscaleOptimization (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 Imagingphysiological signaldisplaymultiplane TEEfourSight TEE Imaging	√	-	-	-	√
■	Stress Echo	√	√	√	√	√
■	Vascular Enhancement(Clarify VE)	√	√	√	√	√
■	Syngo VVI (VelocityVector Image)	√	-	-	√	√
■	Syngo Auto Left Heart(Auto LH)	√	-	-	-	√
■	Axius EF	√	√	√	√	√
■	Syngo AHP	√	-	-	-	√
■	Contrast Agent Image	√	-	-	-	√
■	Advanced fourSight 4D	-	-	-	-	√
■	DIMAQ	√	√	√	√	√
■	Multiple FrequencyImaging(MultiHertz)	√	√	√	√	√
■	syngo Mitral ValveAssessments (MVA)	√	-	-	-	√
■	Digital Architecture	√	√	√	√	√
■	HD Zoom	-	√	√	√	√
■	Fully integrated DICOM	√	√	√	√	√
Feature / Characteristic	PredicateDeviceACUSONX300TM(K121699)	PredicateDeviceACUSONNX3TM(K152469)	PredicateDeviceACUSON NX3EliteTM(K152469)	SubmissionDeviceACUSON NX3	SubmissionDeviceACUSON NX3Elite
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 ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1	Tested to ISO10993-1
UL60601-1 Certified	√	√	√	√	√

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K173957

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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.

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.