The ACUSON NX2TM ultrasound imaging system is 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 NX2TM 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 and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

AI/ML Overview

This document is a 510(k) Summary for the Siemens ACUSON NX2™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics of a novel algorithm.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based feature. Instead, it demonstrates substantial equivalence to predicate devices for its various functionalities and intended uses.

The "perfomance" is indicated by the presence of features and functions ("√" for present, "-" for not present) compared to predicate devices. This implies that if a feature exists and is equivalent to a cleared predicate, it meets the "acceptance criteria" of substantial equivalence.

Feature / Characteristic	Predicate Device ACUSON X700™ (K141846)	Predicate Device ACUSON NX3™ (K152469)	Submission Device ACUSON NX2™	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Indications for Use:				Match/Equivalent to Predicates	All listed indications match (√)
■ Fetal Echo	√	√	√	Present	Present (√)
... (many other clinical applications) ...	√	√	√	Present	Present (√)
Center Frequencies Supported (e.g., 2.0 MHz - 10.0 MHz):	√	√	√	Present	Present (√)
Modes (e.g., B, M, PWD, CD, Power Doppler, Combined):	√	√	√	Present	Present (√)
Features (e.g., SieClear, DTCE, TGO, DICOM, 3D Imaging, Syngo AHP):	√	√	√	Present	Present (√)
Syngo AHP (Arterial Health Package)	√	-	√	Present (if on a predicate)	Present (√)

Note: The document implicitly states that the device is "substantially equivalent with respect to safety and effectiveness" to the predicate devices if these features and characteristics are comparable.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Since the ACUSON NX2™ Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required."

This indicates that there was no specific "test set" of patient data used for clinical testing in this 510(k) submission. The evaluation relies on non-clinical tests and the established safety and effectiveness of the predicate devices. Therefore, there is no information on sample size, data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical test set was used for this specific submission, there is no information regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no clinical test set was used, there is no adjudication method described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No MRMC study was conducted or referenced as clinical data was not required for this submission. The effectiveness is established through substantial equivalence to predicate devices, which have already gone through regulatory clearance.

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

The document does not describe any standalone algorithm performance studies. The "ACUSON NX2™ Diagnostic Ultrasound System" is a complete hardware and software system, not a standalone algorithm. The "Arterial Health Package (AHP) software" mentioned is a component within the system; however, specific standalone performance data for this software is not presented. Its validation is stated as "referenced normative tables that have been validated and published in peer-reviewed studies" (Section C, Page 12).

7. The Type of Ground Truth Used

For the features like the Arterial Health Package (AHP) software, the ground truth for the normative tables it references is established through "peer-reviewed studies" (Section C, Page 12). However, for the overall system's substantial equivalence, the "ground truth" is effectively the established performance and safety of the predicate devices (ACUSON X700™ and ACUSON NX3™) that have already been cleared by the FDA.

8. The Sample Size for the Training Set

No training set is mentioned as clinical data was not required for this submission, and the basis for clearance is substantial equivalence.

9. How the Ground Truth for the Training Set was Established

Since no training set is mentioned in the context of this 510(k) submission, the method for establishing its ground truth is not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 28, 2016

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

Re: K161787

Trade/Device Name: ACUSON NX2" Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 27, 2016 Received: June 29, 2016

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/Resourcesfor You/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 yours.

Michael D.'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) K161787

Device Name ACUSON NX2 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)

	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):

ACUSON NX2™ 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	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9,11,13
	Abdominal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9,13
	Intra-operative(Note 6)
	Intra-operative(Neuro)
Fetal	LaparoscopicPediatric	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9
Imaging& Other	SmallOrgan(Note 1)	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,8,9,10
	Trans-rectal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9
	Trans-vaginal	N	N	N		N	N	BMDC	Note 2,3,4,5,6,8,9,11,
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	N	N	N		N	N	BMDC	Note 2,3,4,6,8,9,
	Musculo-skel.(Superfic)	N	N	N		N	N	BMDC	Note 2,3,4,6,8,9
	Intra -vascular
	Other(Specify)
	Cardiac Adult	N	N	N		N	N	BMDC	Note 2,3,4,6,7,8,12
Cardiac	Cardiac Pediatric	N	N	N		N	N	BMDC	Note 2,3,4,6,8,12
	Intra-vascular(Cardiac)
	Trans-esophageal(Cardiac)
	Intra-Cardiac
	Other (Specify)
Peripheral	Peripheral vessel	N	N	N		N	N	BMDC	Note 2,3,4,6,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared

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

Note 2 Dynamic TCE Technology

Note 3 SieClear
Advanced SieClear Note 4 Note 5
3-Scape 3D Imaging For example: abdominal, vascular Note 6
Note 7 Stress Echo Imaging

Note 8 Clarify Vascular Enhancement Technology

Note 9 SieScape Panoramic Imaging

Note 10 syngo Arterial Health Package (AHP) Note 11 syngo Auto OB Measurements

Note 12 syngo Auto Left Heart (Auto LH) Technology

Note 13 syngo fourSight 4D imaging

(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)

Page 2 of 9

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510(k) Number (if known):

Device Name:

Intended Use:

CH5-2 Convex Array Transducer for use with: 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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,8,9,11
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,8,9
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,5,6,8,9
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	BMDC	Note 2,3,4,6,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K152469

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

Dynamic TCE Technology Note 2

Note 3 SieClear Note 4 Advanced SieClear

Note 5 3-Scape 3D Imaging
For example: abdominal, vascular Note 6

Stress Echo Imaging Note 7

Clarify Vascular Enhancement Technology Note 8

SieScape Panoramic Imaging Note 9

Note 10 syngo Arterial Health Package (AHP)

syngo Auto OB Measurements Note 11 Note 12 syngo Auto Left Heart (Auto LH) Technology

Note 13 syngo fourSight 4D imaging

(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)_

Page 3 of 9

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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 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
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9
Imaging& Other	SmallOrgan(Note 1)	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9
	Neonatal Cephalic
	Adult Cephalic	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9,10
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9
	Musculo-skel.(Superfic)	P	P	P		P	P	BMDC	Note 2,3,4,6,8,9
	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	Note 2,3,4,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared by K152469

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

Note 2 Dynamic TCE Technology

Note 3 SieClear
Advanced SieClear Note 4 Note 5 3-Scape 3D Imaging

Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

Note 8 Clarify Vascular Enhancement Technology

Note 9 SieScape Panoramic Imaging

Note 10 syngo Arterial Health Package (AHP)

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

Note 11

Note 12

Note 13

syngo Auto OB Measurements

syngo fourSight 4D imaging

syngo Auto Left Heart (Auto LH) Technology

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

510(k)_

Page 4 of 9

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C5-2v Convex Array Transducer for use with:

510(k) Number (if known):

Device Name:		C5-2v Convex Array Transducer for use with:ACUSON NX2™ 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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,8,9,11
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,8,9
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,5,6,8,9
	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	N	N	N	N	N	N	BMDC	Note 2,3,4,6,8,9
	Other (Specify)

N = new indication; P = previously cleared

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

Dynamic TCE Technology Note 2
Note 3 SieClear Advanced SieClear Note 4
Note 5 3-Scape 3D Imaging

For example: abdominal, vascular Note 6

Note 7 Stress Echo Imaging
Clarify Vascular Enhancement Technology Note 8

Note 9 SieScape Panoramic Imaging

Note 10 syngo Arterial Health Package (AHP)

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

Note 11

Note 12

Note 13

syngo Auto OB Measurements

syngo fourSight 4D imaging

syngo Auto Left Heart (Auto LH) Technology

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

510(k)_

{7}------------------------------------------------

510(k) Number (if known):

Device Name: Intended Use:

L10-5v Linear Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System

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
	Abdominal	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9
Imaging& Other	SmallOrgan(Note 1)	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9,10
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skel.(Convent.)	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9
	Musculo-skel.(Superfic)	N	N	N	N	N	N	BMDC	Note 2,3,4,8,9
	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	BMDC	Note 2,3,4,8,9
Vessel	Other (Specify)

N = new indication; P = previously cleared

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

Advanced SieClear Note 4
Note 5 3-Scape 3D Imaging

Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

Note 8 Clarify Vascular Enhancement Technology

Note 9 SieScape Panoramic Imaging syngo Arterial Health Package (AHP) Note 10

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

Note 11

Note 12 Note 13 syngo Auto OB Measurements

syngo fourSight 4D imaging

syngo Auto Left Heart (Auto LH) Technology

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 9

Dynamic TCE Technology Note 2 SieClear Note 3

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510(k) Number (if known):

Device Name: Intended Use:

EC9-4 Convex Array Transducer for use with:
ACUSON NX2™ 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 P P P P P BMDC Fetal Note 2,3,4,5,6,8,9,11 Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric lmaging SmallOrgan P P P P P BMDC Note 2,3,4,5,8,9 & Other (Note 1) Neonatal Cephalic Adult Cephalic P Trans-rectal P P P P BMDC Note 2,3,4,5,6,8,9 P P P P P BMDC Note 2,3,4,5,6,8,9,11 Trans-vaginal Trans-urethral Trans-esoph (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-Cardiac Other (Specify) Peripheral vessel Peripheral Vessel Other (Specify)

N = new indication; P = previously cleared by K152469

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

Note 3 SieClear Advanced SieClear Note 4
3-Scape 3D Imaging Note 5
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
Note 8 Clarify Vascular Enhancement Technology

Note 9 SieScape Panoramic Imaging syngo Arterial Health Package (AHP) Note 10

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

Note 11

Note 12

Note 13

syngo Auto OB Measurements

syngo fourSight 4D imaging

syngo Auto Left Heart (Auto LH) Technology

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

510(k)_

Page 7 of 9

Dynamic TCE Technology Note 2

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

Device Name:

Intended Use:

P4-2 Phased Sector Array Transducer for use with: ACUSON NX2™ 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(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P	P	P	P	BMDC	Note 2,8
	Abdominal	P	P	P	P	P	P	BMDC	Note 2,8
	Intra-operative(Note 6)
	Intra-operative(Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging& Other	SmallOrgan(Note 1)	P	P	P	P	P	P	BMDC	Note 2,8
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	BMDC	Note 2,8
	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	BMDC	Note 2,3,4,6,7,8,12
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	BMDC	Note 2,3,4,6, 8,12
	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 Dynamic TCE Technology
Note 3 SieClear Note 4 Advanced SieClear
Note 5 3-Scape 3D Imaging
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
Note 8 Clarify Vascular Enhancement Technology SieScape Panoramic Imaging
Note 9 Note 10 syngo Arterial Health Package (AHP)

syngo Auto OB Measurements Note 11

Note 12 syngo Auto Left Heart (Auto LH) Technology

Note 13 syngo fourSight 4D imaging

(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)_

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

510(k) Number (if known):

Clinical Application				Mode of Operation
Other(Track1Only)	Specific(Tracks1& 3)	B	M	PWD	CWD	ColorDoppler	PowerDoppler	Combined(Specify)	Other(Specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,8,9,11,13
	Abdominal	P	P	P		P	P	BMDC	Note 2,3,4,5,6,8,9,13
	Intra-operative(Note 6)
	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
	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 Dynamic TCE Technology
Note 3 SieClear Note 4 Advanced SieClear
Note 5 3-Scape 3D Imaging

Note 6 For example: abdominal, vascular

Note 7 Stress Echo Imaging

Note 8 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging

Note 10 syngo Arterial Health Package (AHP)

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

Note 11

Note 12

Note 13

syngo Auto OB Measurements

syngo fourSight 4D imaging

syngo Auto Left Heart (Auto LH) Technology

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

510(k)_

Page 9 of 9

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510(k) Summary

Date:	May 14, 2016
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) 279-0134
Device Name:	ACUSON NX2™ Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:	II
	Review Category:	Tier II
	Classification Panel:	Radiology
	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
	Diagnostic Ultrasound Transducer	892.1570	90-ITX

A. Legally Marketed Predicate Devices

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B. Device Description

C. Intended Use

The ACUSON NX2™ ultrasound imaging system is 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.

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™ Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700 ™ Diagnostic Ultrasound System (K141846), and ACUSON NX3 ™ 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 device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX2™ Diagnostic Ultrasound System 510(k) Submission

Feature / Characteristic	Predicate DeviceACUSON X700™(K141846)	Predicate DeviceACUSON NX3™(K152469)	Submission DeviceACUSON NX2™
Indications for Use:
■ 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	√	√	√
Center Frequencies Supported:
■ 2.0 MHz	√	√	√
■ 2.5 MHz	√	√	√
■ 3.0 MHz	√	√	√
■ 3.5 MHz	√	√	√
■ 4.0 MHz	√	√	√
■ 5.0 MHz	√	√	√
■ 5.5 MHz	√	√	√
■ 6.0 MHz	√	√	√
■ 6.5 MHz	√	√	√
■ 7.5 MHz	√	√	√
■ 8.0 MHz	√	√	√
■ 9.0 MHz	√	√	√
■ 10.0 MHz	√	√	√
■ 11.0 MHz	√	√	-
■ 12.0 MHz	√	-	-
■ 13.0 MHz	√	-	-
Modes:
■ B	√	√	√
■ M	√	√	√
■ PWD (Pulsed Wave Doppler)	√	√	√
■ CWD (Continuous WaveDoppler)	√	-	-
■ SCW (Steerable CW)	√	√	√
Feature / Characteristic	Predicate DeviceACUSON X700™(K141846)	Predicate DeviceACUSON NX3™(K152469)	Submission DeviceACUSON NX2™
■ CD (Color Doppler)	√	√	√
■ Amplitude Doppler(Power Doppler)	√	√	√
■ Directional Power Doppler	√	√	√
■ Combined (BM, BC, BCM, BCD)	√	√	√
■ THI (Tissue Harmonic Imaging)	√	√	√
■ AMM (Anatomical M-mode)	√	√	√
■ Doppler Tissue Image (Color, PW)	√	√	√
■ M-THI	√	√	√
Features:
■ 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)	√	-	√
■ Monitor: FPD	√ (20" FPD)	√ (21.5" FPD)	√ (21.5" FPD)
■ Wireless	√	√	√

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON NX2™ 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 to applicable medical device safety standards. The systems comply with the following voluntary standards:

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

Patient contact materials, electrical and mechanical safety are unchanged from the predicate devices.

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

Since the ACUSON NX2™ Diagnostic Ultrasound Systems uses 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™ Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

The ACUSON NX2™ 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.