ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System

K172374 · Siemens Medical Solutions USA, Inc. · IYN · Aug 15, 2017 · Radiology

Device Facts

• Record ID: K172374
• Device Name: ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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 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 Story

Mobile, software-controlled diagnostic ultrasound system; acquires harmonic ultrasound echo data via transducers; displays images in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M-mode, Tissue Doppler, Power Doppler, and 4D imaging on flat panel display. Used in clinical settings by healthcare professionals for anatomical measurement and diagnostic analysis. Includes Arterial Health Package (AHP) for Intima Media Thickness measurement and communication of cardiovascular status. System processes received echoes to generate real-time visualization of structures and fluid flow. Benefits include non-invasive diagnostic assessment of various body systems and cardiovascular risk communication.

Clinical Evidence

No clinical data submitted. Substantial equivalence is based on technological characteristics, bench testing, and compliance with safety standards including AAMI/ANSI ES 60601-1, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system with flat panel display. Modes: B, M, PW/CW Doppler, Color Doppler, Tissue Doppler, Power Doppler, 4D. Connectivity: DICOM 3.0. Software-controlled. Biocompatibility per ISO 10993-1. Electrical/EMC safety per IEC 60601-1-2, IEC 60601-2-18. Acoustic output per AIUM/NEMA UD-2/UD-3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in Cardiac, Fetal, Abdominal, Pediatric, Small Organ, Transcranial, OB/GYN, Pelvic, Urology, Vascular, and Musculoskeletal applications. Used as an imaging aid; specific restrictions apply to IVF, CVS, and PUBS procedures.

Regulatory Classification

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.

Predicate Devices

• ACUSON NX2 (K161787)
• ACUSON S-family Diagnostic Ultrasound System (K163635)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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."

| 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<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combin<br>ed<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | | |
| | Abdominal | P | P | P | | P | P | BMDC | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro)<br>Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | | |
| Imaging<br>& Other | SmallOrgan<br>(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.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | BMDC | | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | | |
| | Intra -vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(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)

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510(k) Number (if known):

Device Name:

Intended Use:

L

ACUSON NX2 Elite Diagnostic Ultrasound System

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

| Clinical Application | Mode of Operation | | | | | | | | |
|----------------------------|------------------------------------------------------|---|---|-----|-----|------------------|------------------|-----------------------|--------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | N | N | N | BMDC | |
| | Abdominal | N | N | N | N | N | N | BMDC | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | N | N | N | N | N | N | BMDC | |
| | SmallOrgan<br>(Note 1) | N | N | N | N | N | N | BMDC | |
| Imaging<br>& 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.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | N | N | N | N | N | N | BMDC | |
| | Musculo-skel.<br>(Superfic) | N | N | N | N | N | N | BMDC | |
| | Intra -vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | BMDC | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | BMDC | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | 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

(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)

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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<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | | |
| | Abdominal | P | P | P | | P | P | BMDC | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | BMDC | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | 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<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | |
| | Abdominal | P | P | P | | P | P | BMDC | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | BMDC | |
| | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | 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

(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)

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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<br>( Track1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | BMDC | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | |
| Imaging<br>& Other | SmallOrgan<br>(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.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | BMDC | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(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

(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:

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<br>( Track1<br>Only) | Specific<br>(Tracks 1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combin<br>ed<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric<br>SmallOrgan<br>(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.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | 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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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

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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<br>( Track1<br>Only) | Specific<br>(Tracks1I& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | |
| | Abdominal | P | P | P | | P | P | BMDC | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(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

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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<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(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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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<br>(Track1<br>Only) | Specific<br>(Tracks1I& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | P | | | | | |
| | Cardiac Pediatric | | | P | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | 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)

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### 510(k) Summary

| Date: | June 15, 2017 | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|--------|
| Submitter: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 | | |
| Manufacturing<br>Facility: | Siemens Healthcare Ltd.<br>2nd -3rd floor, 143, Sunhwan-ro,<br>Jungwon-gu, Seongnam-si, Gyeonggi-do,<br>Republic of Korea | | |
| Contact Person: | Shelly Pearce<br>Tel: [phone]<br>Fax: [phone] | | |
| Device Name: | ACUSON NX2 Diagnostic Ultrasound System<br>ACUSON NX2 Elite Diagnostic Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification: | Regulatory Class: II<br>Review Category: Tier II<br>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

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

{15}------------------------------------------------

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

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.

## 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.

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."

### 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 Device<br>ACUSON S-family<br>(K163635) | Predicate Device<br>ACUSON NX2™<br>(K161787) | Submission<br>Device<br>ACUSON 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…