The ACUSON NX2 and NX2 Elite diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), 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 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 Elite Diagnostic Ultrasound System is a 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, 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, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

AI/ML Overview

This document describes a 510(k) premarket notification for the "ACUSON NX2 Diagnostic Ultrasound System" and the "ACUSON NX2 Elite Diagnostic Ultrasound System." The submission aims to demonstrate substantial equivalence to previously cleared devices rather than providing a study proving performance against defined acceptance criteria.

The core of this submission is the claim of substantial equivalence to existing legally marketed predicate devices, specifically the ACUSON NX2 (K161787) and features from the ACUSON S-family Diagnostic Ultrasound System (K163635). This means that the manufacturer is asserting the new device is as safe and effective as the predicate devices, and therefore, extensive new clinical studies with defined acceptance criteria are generally not required by the FDA.

Here's an breakdown of the information based on your request, noting that many items are not applicable in a 510(k) substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a specific table of acceptance criteria with reported device performance in the way one would see for a novel device undergoing a performance study. Instead, the "performance" is implicitly demonstrated through the claim of equivalence to already cleared devices. The document does list safety standards the device complies with, which could be considered a form of acceptance criteria (see point 5).

Category	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Intended Use	Equivalent to predicate devices (K161787, K163635) for various clinical applications (Cardiac, Fetal, Abdominal, Pediatric, Small Organ etc.) and imaging modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Combined, Harmonic Imaging, 4D).	The ACUSON NX2 Elite offers the same clinical applications and modes as K161787, plus additional applications with new transducers (CW2, CW5) and software features (Advanced foursight 4D, eSieTouch) cleared on K163635.
Technological Characteristics	Similar technological characteristics to predicate devices (transmit ultrasonic energy, post-processing, measurements, calculations).	The submission device performs these functions equivalently to the predicate devices.
Safety Standards Compliance	Conformity to applicable medical device safety standards.	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety, and found to conform with: AAMI/ANSI ES 60601-1, IEC 60601-2-37, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, IEC 60601-1-2, IEC 60601-2-18, 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. The document explicitly states: "A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence. Since the ACUSON NX2 Elite Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required." This indicates no new clinical test set was required for this particular submission.

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, as no new clinical test set was required for this substantial equivalence submission.

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

Not applicable, as no new clinical test set was required for this substantial equivalence submission.

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-assisted device and no MRMC study was conducted or required for this substantial equivalence submission.

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

Not applicable. This is a diagnostic ultrasound system, not an algorithm-only device. Its performance is tied to the human operator interpreting the images.

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

Not applicable, as no new clinical test set with explicit ground truth determination was required for this substantial equivalence submission. The "ground truth" for the predicate devices would have been established through their own clearance processes.

8. The sample size for the training set

Not applicable. This document is for a diagnostic ultrasound system based on existing technology and principles, not an AI/machine learning device that would require explicit training sets.

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

Not applicable, as no training set was used for this type of submission.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design extending from the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2017

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

Re: K172374

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: August 3. 2017 Received: August 7, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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Indications for Use

510(k) Number (if known)

K172374

Device Name ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number (if known):

Device Name: Intended Use:

ACUSON NX2™ Diagnostic Ultrasound System

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(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC
	Abdominal	P	P	P		P	P	BMDC
	Intra-operative(Note 2)
	Intra-operative(Neuro)Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC
	Trans-rectal	P	P	P		P	P	BMDC
	Trans-vaginal	P	P	P		P	P	BMDC
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC
	Intra -vascular
	Other(Specify)
	Cardiac Adult	P	P	P	P	P	P	BMDC
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P		P	P	BMDC
Vessel	Other (Specify)

N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

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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:

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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC
	Abdominal	N	N	N	N	N	N	BMDC
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	BMDC
	SmallOrgan(Note 1)	N	N	N	N	N	N	BMDC
Imaging& Other	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	BMDC
	Trans-rectal	N	N	N	N	N	N	BMDC
	Trans-vaginal	N	N	N	N	N	N	BMDC
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	N	N	N	N	N	N	BMDC
	Musculo-skel.(Superfic)	N	N	N	N	N	N	BMDC
	Intra -vascular
	Other(Specify)
	Cardiac Adult	N	N	N	N	N	N	BMDC
Cardiac	Cardiac Pediatric	N	N	N	N	N	N	BMDC
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N	BMDC
	Other (Specify)
	N = new indication; P = previously cleared (K161797)

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

Note 2 For example: abdominal, vascular

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

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510(k) Number (if known):

CH5-2 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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC
	Abdominal	P	P	P		P	P	BMDC
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	BMDC
	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	BMDC
	Other (Specify)

N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

(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):

Device Name:

Intended Use:

VF10-5 Linear Array Transducer 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 Specific Color Power Combined Other B M PWD CWD ( Track 1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal Abdominal P P P P P BMDC Intra-operative (Note 2) Intra-operative (Neuro) Laparoscopic Pediatric Fetal P P P P P BMDC SmallOrgan Imaging P P P & Other P P BMDC (Note 1) Neonatal Cephalic Adult Cephalic P P P P P BMDC Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. P P P P P BMDC (Convent.) Musculo-skel. P P P P P BMDC (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac Other (Specify) Peripheral vessel Peripheral P P P BMDC P P Vessel Other (Specify)

N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

(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):

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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC
	Abdominal	P	P	P		P	P	BMDC
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	BMDC
	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	BMDC
	Other (Specify)

N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

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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:

L10-5v Linear Array 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( Track1Only)	Specific(Tracks11& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	BMDC
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC
	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	BMDC
Vessel	Other (Specify)
	N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

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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):

Device Name:

EC9-4 Convex Array Transducer 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:

Intended Use:

Clinical Application		Mode of Operation
Other( Track1Only)	Specific(Tracks 1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	PediatricSmallOrgan(Note 1)	P	P	P		P	P	BMDC
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	BMDC
	Trans-vaginal	P	P	P		P	P	BMDC
	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 (K161787)

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

Note 2 For example: abdominal, vascular

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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:

P4-2 Phased Sector Array Transducer 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:

Intended Use: Clinical Application Mode of Operation Other Specific Color Power Combined Other M PWD CWD ( Track1 B (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic Fetal P P P P P BMDC P P P Abdominal P P BMDC Intra-operative (Note 2) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan P P P P P BMDC & Other (Note 1) Neonatal Cephalic P Adult Cephalic P P P P BMDC Trans-rectal Trans-vaginal Trans-urethral Trans-esoph (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) P P P P P Cardiac Adult P BMDC Cardiac P P P P P BMDC 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 (K161787)

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

Note 2 For example: abdominal, vascular

(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):

C8F3 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( Track1Only)	Specific(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC
	Abdominal	P	P	P		P	P	BMDC
	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)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

N = new indication; P = previously cleared (K161787)

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

Note 2 For example: abdominal, vascular

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

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

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510(k) Number (if known):

Device Name:

Intended Use:

CW2 Transducer for use with: 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(Specify)	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 (K163635)

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

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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:

CW5 Transducer for use with: 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(Tracks1I& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intra-operative(Note 2)
	Intra-operative(Neuro)
	Laparoscopic
	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	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 (K161787)

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

Note 2 For example: abdominal, vascular

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

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

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510(k) Summary

Date:	June 15, 2017
Submitter:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
ManufacturingFacility:	Siemens Healthcare Ltd.2nd -3rd floor, 143, Sunhwan-ro,Jungwon-gu, Seongnam-si, Gyeonggi-do,Republic of Korea
Contact Person:	Shelly PearceTel: (650) 279-0134Fax: (650) 694-5580
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

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cleared on ACUSON S-family Diagnostic Ultrasound System (K163635). Also, two more software features are Advanced foursight 4D and eSieTouch which are also cleared on ACUSON S-family Diagnostic Ultrasound System (K163635).

B. Device Description

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

C. Intended Use

The ACUSON NX2 and NX2 Elite diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), 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.

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.

D. Substantial Equivalence

The ACUSON NX2 Elite Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software. It is substantially equivalent to ACUSON NX2 (K161787). It has two more transducers and two more software features compared to ACUSON NX2 (K161787). The two more transducers of ACUSON NX2 Elite are CW2 and CW5 which are cleared on ACUSON S-family Diagnostic Ultrasound System (K163635). Also, two more software features are Advanced foursight 4D and eSieTouch which are also cleared on

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ACUSON S-family Diagnostic Ultrasound System (K163635). 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 device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

	Feature / Characteristic	Predicate DeviceACUSON S-family(K163635)	Predicate DeviceACUSON NX2™(K161787)	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	√	√	√
	Feature / Characteristic	Predicate DeviceACUSON S-family(K163635)	Predicate DeviceACUSON NX2™(K161787)	SubmissionDeviceACUSON NX2 Elite
■	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)	√	√	√
■	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" FPD)	√ (21.5" FPD)	√ (21.5" FPD)
Feature / Characteristic	Predicate DeviceACUSON S-family(K163635)	Predicate DeviceACUSON NX2TM(K161787)	SubmissionDeviceACUSON NX2 Elite
Wireless	√	√	√

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX2, ACUSON NX2 Elite Diagnostic Ultrasound System 510(k) Submission

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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 with applicable medical device safety standards. The systems comply with the following voluntary standards:

AAMI/ANSI ES 60601-1, Safety Requirements for Medical Equipment
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
I IEC 62359, Test methods for the determination of thermal and mechanical indices
I Safety and EMC Requirements for Medical Equipment
- . IEC 60601-1-2
- IEC 60601-2-18
" ISO 10993-1 Biocompatibility

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

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

Since the ACUSON NX2 Elite Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required.

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

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 Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. 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 Elite Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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The ACUSON NX2 Elite Diagnostic Ultrasound System is verified and validated according to the company's design control process.

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

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.