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

K173957 · Siemens Medical Solutions USA, Inc. · IYN · Feb 1, 2018 · Radiology

Device Facts

• Record ID: K173957
• Device Name: ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Feb 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

For ACUSON NX3 The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. For ACUSON NX3 Elite The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physicial with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physicial with an easily understood tool for communicating with patients regarding state of their cardiovascular system. Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

Device Story

Mobile, software-controlled diagnostic ultrasound systems; acquire harmonic ultrasound echo data; display in B-Mode, PW/CW Doppler, Color Doppler, Color M, Tissue Doppler, Amplitude Doppler, and 3D/4D imaging. Used in clinical settings by healthcare professionals. Systems perform post-processing of received echoes to generate on-screen displays of anatomical structures and fluid flow. Includes measurement and analysis packages (e.g., Arterial Health Package for Intima Media Thickness) to assist clinical diagnosis. Provides thermal and mechanical indices for bio-effect monitoring. Benefits include non-invasive visualization and quantification of internal structures and blood flow to support clinical decision-making.

Clinical Evidence

No clinical data submitted. Substantial equivalence is based on technological characteristics, bench testing (acoustic output, biocompatibility, thermal/mechanical safety), and adherence to recognized safety standards (IEC 60601 series, ISO 10993-1).

Technological Characteristics

Mobile ultrasound system; 64-channel architecture; 21.5" FPD monitor. Supports B, M, PWD, CWD, Color/Power Doppler modes. Materials tested to ISO 10993-1. Connectivity: DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-2-37, IEC 60601-1-2, AIUM/NEMA UD-2/UD-3.

Indications for Use

Indicated for fetal, abdominal, pediatric, small parts, neonatal/adult cephalic, transcranial, OB/GYN, pelvic, neonatal, cardiac, vascular, musculoskeletal, and urology diagnostic ultrasound imaging and measurement in patients requiring clinical diagnosis.

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 NX3 and ACUSON NX3 Elite (K152469)
• ACUSON X300PE Diagnostic Ultrasound System (K121699)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

February 1, 2018

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

# Re: K173957

Trade/Device Name: ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 26, 2018 Received: January 29, 2018

# Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Mr. Mark Job

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENTO FHEACTH AND HUMANISERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below,

#### 510(k) Number (if known)

K173957

Device Name

ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System

Indications for Use (Describe)

For ACUSON NA

The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Crean), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vesse), Musculoskeletal and Urology applications,

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

#### FOT ACQUISON NEWS FITTE

The ACUSON NX3 Elite ultrasound imaging system is mended for the following applications: Fetal. Abdominal (including liver, intra-operative). Pediative intra-overative). Neonative). Neonatal Cenhalic. Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel, intra-operative Musculoskeletal, Superficial Musculoskeletal and Urology applications,

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

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

Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Caroud Ultrasound to Icentify Subchical Vasular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine "

#### Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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510(k) Number (if known):

Device Name: Intended Use: K173957 ACUSON NX3 Elite™ Diagnostic Ultrasound System

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

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

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

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

Note 2 For example: abdominal, vascular

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

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

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510(k)_

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| 510(k) Number (if known): | K173957 |
|---------------------------|------------------------------------------------------------------------|
| Device Name: | ACUSON NX3™ Diagnostic Ultrasound System |
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

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

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

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

Note 2

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

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

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

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510(k)_

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| 510(k) Number (if known): | K173957 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CH5-2 Transducer for use with:<br>ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System |
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |

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

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

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

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

Note 2 For example: abdominal, vascular

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

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

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Page 3 of 19

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| 510(k) Number (if known): | K173957 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VF10-5 Linear Array Transducer for use with:<br>ACUSON NX3 EliteTM Diagnostic Ultrasound System / ACUSON NX3TM Diagnostic Ultrasound<br>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>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic<br>Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P | |
| | Other (Specify) | | | | | | | | |

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

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

Note 2 For example: abdominal, vascular Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3

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

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510(k)_

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| 510(k) Number (if known): | K173957 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

**VF12-4** Linear Array Transducer for use with:

VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic<br>– NX3 Elite only | P | P | P | | P | P | P | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | |
| | 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 | P | |
| | Other (Specify) | | | | | | | | |

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

Note 2 For example: abdominal, vascular

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

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

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

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510(k)_

Page 5 of 19

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510(k) Number (if known): K173957

Device Name: Intended Use: EC10-5w Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System

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

| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
|----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | P | P | P | | P | P | P | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<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 by (K152469)

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

Note 2 For example: abdominal, vascular

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

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

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

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

510(k)_

Page 6 of 19

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

| 510(k) Number (if known): | K173957 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | P | P | P | | P | P | P | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric<br>SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | P | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | P | P | P | P | |
| | Trans-vaginal | P | P | P | P | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | 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 by (K152469)

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

Note 2 For example: abdominal, vascular

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

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

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

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

510(k)_

Page 7 of 19

{11}------------------------------------------------

| 510(k) Number (if known): | K173957 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Device Name: | CW2 Continuous Wave Doppler Transducer for use with:<br>ACUSON NX3 Elite™ Diagnostic Ultrasound System |
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

| Clinical Application | | Mode of Operation | | | | | | | | |
|-----------------------------|---------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | |
| | 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 | 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 by (K152469) | | | | | | | | | |

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

Note 2 For example: abdominal, vascular

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

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

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

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

Page 8 of 19

{12}------------------------------------------------

| 510(k) Number (if known): | K173957 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Device Name: | CW5 Continuous Wave Doppler Transducer for use with:<br>ACUSON NX3 Elite™ Diagnostic Ultrasound System |
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows |

| Clinical Application | | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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 Adult | | | | P | | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |

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

Note 2 For example: abdominal, vascular

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

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

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

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

Page 9 of 19

{13}------------------------------------------------

| 510(k) Number (if known): | K173 |
|---------------------------|------|
|---------------------------|------|

Device Name:

3957

P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System

Intended Use:

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

| Clinical Application | | Mode of Operation | | | | | | | Other<br>(Specify) |
|----------------------------|---------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal | Fetal | P | P | P | P | P | P | P | |
| | Abdominal | P | P | P | P | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | P | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | |
| | Cardiac Pediatric | P | P | P | P | P | P | 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 by (K152469)

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

Note 2 For example: abdominal, vascular

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

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

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

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

510(k)_

Page 10 of 19

{14}------------------------------------------------

510(k) Number (if known): K173957

VF16-5 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name:

Intended Use:

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

======

| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | |
| | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | | |
| | 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 by (K152469)

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

Note 2 For example: abdominal, vascular

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

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

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

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

Page 11 of 19

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

510(k) Number (if known): K173957

VF13-5sp Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name:

Intended Use:

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

================

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