The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

Note: This feature can 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 NX2 / ACUSON NX2 Elite 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. Their functions are to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaqing on a Flat Panel Display.

AI/ML Overview

This is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML device. Therefore, the typical acceptance criteria and study components related to software performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or provided in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)) by comparing intended use, technological characteristics, and compliance with safety standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device with specific performance metrics like sensitivity/specificity, the 'acceptance criteria' are primarily related to safety, operational modes, and clinical applications, demonstrating equivalence to the predicate device. The performance is implied by its equivalence to a previously cleared device and compliance with established safety and performance standards.

Acceptance Criteria (Implied from Substantial Equivalence to K172374)	Reported Device Performance (Submission Device: ACUSON NX2/NX2 Elite)
Intended Use Equivalence: Same clinical applications as predicate: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel), Musculoskeletal.	Matches predicate's intended uses across all listed clinical applications.
Technological Characteristics Equivalence: Same operational modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Combined modes, THI, AMM, etc.) and features as predicate.	Matches predicate's operational modes and most features, including new transducer types (10MC3, C8F3, CW2, CW5) also matching predicate's capabilities or having equivalent performance. New indications for the 10MC3 transducer are clearly marked.
Safety and Performance Standards Compliance: Conformance to recognized standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.	Verified to conform to applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-37, AIUM/NEMA UD-3, IEC 62359, IEC 60601-1-2, ISO 10993-1).

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

Not applicable. This is a submission for a diagnostic ultrasound system, not a software algorithm requiring a test set of patient data to evaluate performance metrics. The evaluation focuses on engineering, safety, and functional equivalence.

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)

Not applicable. Ground truth for diagnostic performance evaluation is not relevant for this type of device submission.

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

Not applicable. No test set requiring adjudication of ground truth is mentioned.

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

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm-only device. It's a diagnostic ultrasound system.

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

Not applicable. Clinical performance data is not provided as part of this 510(k) submission, as it relies on substantial equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.

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

February 2, 2018

Re: K173981

Trade/Device Name: ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 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 - 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

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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)

K173981

Device Name

ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications Cardiac. Fetal. Abdominal (including liver), Pediatric, Small Organ), Adult Cephalic, Transcranial, OBA GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), choronic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Ident to Subclinical Vascular Disease and Evaluate Cardiovasular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vasoular Medicine

100as applicable)Selectonepoinuse
Inne

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"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 number "

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510(k) Number (if known):

Device Name: Intended Use: K173981

QUICK-HYVE™ D: 6-Hy -Isoflavone

ACUSON NX2™ 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
	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	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	P
	Musculo-skel.(Superfic)	P	P	P		P	P	P
	Intra -vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared (K172374)

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

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510(k) Number (if known):

Device Name:

Intended Use:

K173981

ACUSON NX2 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
	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	P
	Trans-rectal	P	P	P		P	P	P
	Trans-vaginal	P	P	P		P	P	P
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	P
	Musculo-skel.(Superfic)	P	P	P		P	P	P
	Intra -vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)
	N = new indication; P = previously cleared (K172374)

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

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510(k) Number (if known):		K173981
Device Name:		CH5-2 Convex Array Transducer for use with:ACUSON NX2 TM Diagnostic Ultrasound System /ACUSON NX2 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)
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		P	P	P		P	P	P
	SmallOrgan(Note 1)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel		P	P	P		P	P	P
	Other (Specify)

N = new indication; P = previously cleared (K172374)

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

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)_

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510(k) Number (if known):	K173981
Device Name:	VF10-5 Linear Array Transducer

Intended Use:

er for use with: ACUSON NX2™ Diagnostic Ultrasound System / ACUSON NX2 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
	Abdominal	P	P	P		P	P	P
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	P
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	P
	Musculo-skel.(Superfic)	P	P	P		P	P	P
	Intra-vascular
	Other(Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

previously cleared (K172374) N = new tion: F =

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):	K173981
---------------------------	---------

C5-2v Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / ACUSON NX2 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	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)
	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	Peripheral vessel	P	P	P		P	P	P
Vessel	Other (Specify)

N = new indication; P = previously cleared (K172374)

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

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L10-5v Linear Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / Device Name: ACUSON NX2 Elite Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

K173981

Intended Use:

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

N = new indication; P = previously cleared (K172374)

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)_

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EC9-4 Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / Device Name: ACUSON NX2 Elite Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:

K173981

Intended Use:

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
FetalImaging& Other	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	SmallOrgan(Note 1)	P	P	P		P	P	P
	Neonatal Cephalic
	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	Cardiac Adult
	Cardiac Pediatric
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication; P = previously cleared (K172374)

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)

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

510(k) Number (if known):

Device Name:

K173981

Intended Use:		ACUSON NX2™ Diagnostic Ultrasound System /ACUSON NX2 Elite Diagnostic Ultrasound SystemDiagnostic 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	P	P	P		P	P	P
	Abdominal	P	P	P		P	P	P
	Intra-operative(Note 2)
	Intra-operative(Neuro)
Fetal	Laparoscopic
	Pediatric
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.)
	Musculo-skel.(Superfic)
	Intra-vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	P
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

Diagnostic Ultrasound Indications for Use Form

P4-2 Phased Sector Array Transducer for use with:

N = new indication; P = previously cleared (K172374)

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)

510(k)_

Indications for Use Forms

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510(k) Number (if known):	K173981
Device Name:	C8F3 Transducer for use with:ACUSON NX2™ Diagnostic Ultrasound System /ACUSON NX2 Elite Diagnostic Ultrasound System
Intended Use:	Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Note 3)	Other(Specify)
	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)

Other (Specify) N = new indication; P = previously cleared (K172374)

Peripheral vessel

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

510(k)_

Peripheral

Vessel

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510(k) Number (if known):		K173981
Device Name:		CW2 Transducer for use with:ACUSON NX2 Elite Diagnostic Ultrasound System
Intended Use:			Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
Other( Track 1Only)	Specific(Tracks11& 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				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	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared (K172374)

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

Note 2 For example: abdominal, vascular

r of oxampler abdominal, vaosala:
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Number (if known):		K173981
Device Name:		CW5 Transducer for use with:ACUSON NX2 Elite Diagnostic Ultrasound System
	Intended Use:		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
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	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	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared (K172374)

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

Note 2 For example: abdominal, vascular

r of oxampler abdominal, vaosala:
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Number (if known):	K173981
Device Name:	10MC3 Transducer for use with:ACUSON NX2™ Diagnostic Ultrasound System /ACUSON NX2 Elite Diagnostic Ultrasound System
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	N	N	N		N	N	N
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric
	SmallOrgan(Note 1)	N	N	N		N	N	N
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N		N	N	N
	Trans-vaginal	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)
PeripheralVessel	Peripheral vessel
	Other (Specify)

N = new indication: P = previously cleared

N = new indication; P = previously cleared

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

Note 2 For example: abdominal, vascular

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

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

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510(k) Summary

Date:	January 24, 2018
Submitter:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain 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 ChoiTel: (425) 281-9898
Device Name:	ACUSON NX2 Diagnostic Ultrasound SystemACUSON NX2 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-IYO
	Diagnostic Ultrasound Transducer	892.1570	90-ITX

A. Legally Marketed Predicate Devices

The ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products, the ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374).

Primary Predicate Device(s): ACUSON NX2 and ACUSON NX2 Elite (K172374) .

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B. Device Description

C. Intended Use

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

D. Substantial Equivalence

The ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products. ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374). 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	Predicate DeviceACUSON NX2(K172374)	Predicate DeviceACUSON NX2 Elite(K172374)	SubmissionDeviceACUSON NX2	SubmissionDeviceACUSON NX2 Elite
■	Fetal Echo	√	√	√	√
■	Abdominal	√	√	√	√
■	Renal	√	√	√	√
■	Cerebrovascular	√	√	√	√
■	Orthopedics	√	√	√	√
■	Small Organ	√	√	√	√
■	Pediatric	√	√	√	√
■	Adult Cephalic	√	√	√	√
■	Cardiac (Adult)	√	√	√	√
■	Intracardiac	-	-	-	-
■	Trans-esophageal	√	√	√	√
■	Transrectal	√	√	√	√
■	Urolology	√	√	√	√
■	Transvaginal	√	√	√	√
■	Peripheral vessel	√	√	√	√
■	Musculo-skeletal (conventional)	√	√	√	√
■	Musculo-skeletal (superficial)	√	√	√	√
■	Emergency Medicine	√	√	√	√
■	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	-	-	-	-
■	B	√	√	√	√
■	M	√	√	√	√
■	PWD (Pulsed Wave Doppler)	√	√	√	√
■	CWD (Continuous Wave Doppler)	-	-	-	-
■	SCW (Steerable CW)	√	√	√	√
■	CD (Color Doppler)	√	√	√	√
■	Amplitude Doppler(Power Doppler)	√	√	√	√
■	Directional Power Doppler	√	√	√	√
■	Combined (BM, BC, BCM, BCD)	√	√	√	√
■	THI (Tissue Harmonic Imaging)	√	√	√	√
■	AMM (Anatomical M-mode)	√	√	√	√
Feature / Characteristic	Predicate DeviceACUSON NX2(K172374)	Predicate DeviceACUSON NX2 Elite(K172374)	SubmissionDeviceACUSON NX2	SubmissionDeviceACUSON NX2 Elite
■ Doppler Tissue Image (Color, PW)	-	√	-	√
■ M-THI	√	√	√	√
■ US Security (Virus Protection)	√	√	√	√
■ Multi-View Spatial Compounding(SieClear)	√	√	√	√
■ Advanced SieClear (SieClear =Multi-View Spatial Compounding)	√	√	√	√
■ DTCE (Dynamic Tissue ContrastEnhancement)	√	√	√	√
■ TGO (Tissue GrayscaleOptimization)	√	√	√	√
■ HD Zoom	√	√	√	√
■ DICOM (3.0 connectivity, Worklist,MPPS)	√	√	√	√
■ DICOM SR OB/GYN	√	√	√	√
■ DICOM SR Cardiac	√	√	√	√
■ DICOM SR Vascular	√	√	√	√
■ 3D Imaging (3-Scape)	√	√	√	√
■ 3D Measurements	√	√	√	√
■ 4D Basic Imaging (fourSight 4D)	√	√	√	√
■ Panoramic 2D Imaging	√	√	√	√
■ Syngo Auto OB	√	√	√	√
■ Stress Echo	√	√	√	√
■ Vascular Enhancement (ClarifyVE)	√	√	√	√
■ VET(Pictogram)	√	√	√	√
■ Auto Left Heart	√	√	√	√
■ Syngo AHP (Arterial HealthPackage)	√	√	√	√
■ Advanced fourSight 4D	-	√	-	√
■ eSieTouch	-	√	-	√
■ Monitor: FPD	√ (21.5" FPD)	√ (21.5" FPD)	√ (21.5" FPD)	√ (21.5" FPD)
■ Wireless	√	√	√	√

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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 device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to 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

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. 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
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
. AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
. IEC 62359:2010, Ultrasonics – Field characterization – Test Methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
. IEC 60601-1-2: 2007(Third Edition), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-2-18:2009, Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
. 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 NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.

G. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON NX2 / NX2 Elite Diagnostic Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The ACUSON NX2 / NX2 Elite Diagnostic Ultrasound System is 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.