ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System

K152469 · Siemens Medical Solutions, Inc., Ultrasound Division · IYN · Sep 21, 2015 · Radiology

Device Facts

• Record ID: K152469
• Device Name: ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
• Applicant: Siemens Medical Solutions, Inc., Ultrasound Division
• Product Code: IYN · Radiology
• Decision Date: Sep 21, 2015
• 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), 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. 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. For ACUSON NX3 Elite ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), 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. 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 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 systems; acquire harmonic echo data; display in B-Mode, PW/CW Doppler, Color Doppler, Color M-mode, Tissue Doppler, Power Doppler, 3D/4D imaging. Used in clinical settings by healthcare professionals. Inputs: ultrasonic energy transmitted into patient; echoes received and processed. Outputs: real-time anatomical/fluid flow images on flat panel display; measurement/analysis packages. AHP software measures Intima Media Thickness for cardiovascular risk communication. Benefits: non-invasive diagnostic imaging aid for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including acoustic output, biocompatibility, and electrical/mechanical safety standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Digital architecture; 64-channel processing; 21.5" FPD. Modes: B, M, PWD, CWD, Color/Power Doppler, 3D/4D. Features: SieClear, Advanced SieClear, DTCE, TGO, Dual/Quad-beam processing, syngo Auto OB/Follicle/Left Heart, AHP, eSie Touch. Patient contact materials tested to ISO 10993-1. Connectivity: DICOM, wireless.

Indications for Use

Indicated for fetal, abdominal, pediatric, small organ, transcranial, OB/GYN, pelvic, neonatal, cardiac, vascular, musculoskeletal, and urology imaging. Includes intra-operative applications for NX3 Elite. Used as imaging aid for 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 X700 Diagnostic Ultrasound System (K141846)
• ACUSON X300 Diagnostic Ultrasound System (K121699)

Submission Summary (Full Text)

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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 graphic of three human profiles facing to the right, with flowing lines beneath them.

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

September 21, 2015

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

Re: K152469

Trade/Device Name: ACUSON NX3 Elite and ACUSON NX3 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 28, 2015 Received: August 31, 2015

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert Odlo

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) K152469

### Device Name

ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems

# Indications for Use (Describe)

For ACUSON NX3

The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), 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.

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.

## For ACUSON NX3 Elite

ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), 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.

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 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Number (if known):

Device Name: Intended Use:

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>(Tracks 1 & 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 | Note 2,3,4,5,6,9,10,12,14 |
| | Abdominal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,15 |
| | Intra-operative<br>(Note 6) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,17 |
| | Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9 |
| | Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,11 |
| | Trans-rectal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| | Trans-vaginal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10,12,14,16 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,11 |
| | Musculo-skel.<br>(Superfic) | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 |
| | Intra -vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | BMDC | Note 2,7,8,9,13, |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9,13 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | BMDC | Note 2,3,4,6,9,10 |
| Vessel | 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
- Note 4 Advanced SieClear 3-Scape 3D Imaging
- Note 5 For example: abdominal, vascular Note 6
- Note 7 Stress Echo Imaging

Note 8 Axius Edge Assisted Ejection Fraction

Clarify Vascular Enhancement Technology Note 9

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

Contrast Agent Imaging (NX3 Elite only) Note 15

syngo Auto follicle Note 16

eSie Touch (NX3 Elite only) Note 17

(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:

ACUSON NX3TM Diagnostic Ultrasound System

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>(Tracks11& 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 | BMDC | Note 2,3,4,5,6,9,10,12,14 | |
| | Abdominal | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9 | |
| | Trans-rectal | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| | Trans-vaginal | N | N | N | | N | N | BMDC | Note 2,3,4,5,9,10,12,16 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| | Musculo-skel.<br>(Superfic) | N | N | N | | N | N | BMDC | Note 2,3,4,9,10 | |
| | Intra -vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | N | N | N | | N | N | BMDC | Note 2,7,8,9 | |
| Cardiac | Cardiac Pediatric | N | N | N | | N | N | BMDC | Note 2,7,8,9 | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| Vessel | 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
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7 Axius Edge Assisted Ejection Fraction Note 8
- Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging

- syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

Note 14 syngo fourSight 4D imaging

Contrast Agent Imaging (NX3 Elite only) Note 15

syngo Auto follicle Note 16

Note 17 eSie Touch (NX3 Elite only)

(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):

CH5-2 Transducer for use with:

ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound Device Name: 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>(Tracks1l& 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 | Note 2,3,4,5,6,9,10,12 | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,15,16 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10 | |
| 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 | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10 | |
| Vessel | Other (Specify) | | | | | | | | | |

N = new indication; P = previously cleared by K141846

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

- Dynamic TCE Technology Note 2
- SieClear Note 3 Note 4
- Advanced SieClear 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- Note 10 SieScape Panoramic Imaging

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)
-

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

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

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

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510(k) Number (if known):

Device Name:

VF10-5 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>( 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 | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,16 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,9,10 | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,17 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10 | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10 | |
| | 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 | Note 2,3,4,9,10 | |

N = new indication; P = previously cleared K141846

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

- Dynamic TCE Technology Note 2
- Note 3 SieClear Advanced SieClear Note 4

3-Scape 3D Imaging Note 5

- Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging

Axius Edge Assisted Ejection Fraction Note 8

Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only) Note 12 syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13

- syngo fourSight 4D imaging Note 14
Contrast Agent Imaging (NX3 Elite only) Note 15

- Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)

(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:

**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>( 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 | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,16 |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 |
| | Neonatal Cephalic<br>- NX3 Elite only | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | Musculo-skel.<br>(Superfic) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | 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 | BMDC | Note 2,3,4,9,10 |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by K141846

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

Dynamic TCE Technology Note 2

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

- Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging

Axius Edge Assisted Ejection Fraction Note 8

- Clarify Vascular Enhancement Technology Note 9
SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)

syngo fourSight 4D imaging Note 14

Contrast Agent Imaging (NX3 Elite only) Note 15 Note 16 syngo Auto follicle

- Note 17 eSie Touch (NX3 Elite only)
(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)_

{9}------------------------------------------------

510(k) Number (if known):

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:

| 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 | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,12 |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10 |
| | Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6, 9,10 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10 |
| | Trans-vaginal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10,12,16 |
| | 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

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

Dynamic TCE Technology Note 2 SieClear Note 3

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

Note 7 Stress Echo Imaging

- Note 8 Axius Edge Assisted Ejection Fraction
Note 9 Clarify Vascular Enhancement Technology

Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13

Note 14 syngo fourSight 4D imaging

Note 15 Contrast Agent Imaging (NX3 Elite only)

Note 16 syngo Auto follicle

Note 17 eSie Touch (NX3 Elite only)

(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)

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

510(k) Number (if known):

Device Name:

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

Intended Use:

System 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>(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 | Note 2,3,4,5,6,9,10,12 |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | BMDC | Note 2,3,4,5,6, 9,10 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Trans-vaginal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,12,16 |
| | 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 K121699

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

- Note 2 Note 3 SieClear
- Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5

For example: abdominal, vascular Note 6

- Note 7 Stress Echo Imaging
Axius Edge Assisted Ejection Fraction Note 8

- Clarify Vascular Enhancement Technology Note 9
- SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

Note 12 syngo Auto OB Measurements Note 13

syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 14 syngo fourSight 4D imaging

- Contrast Agent Imaging (NX3 Elite only) Note 15
- syngo Auto follicle Note 16
- Note 17 eSie Touch (NX3 Elite only)

(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)_

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

510(k) Number (if known):

CW2 Continuous Wave Doppler Transducer for use with: Device Name: 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>( 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 | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | 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 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 by K141846

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

- Note 2 Dynamic TCE Technology
- Note 3 SieClear Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- SieScape Panoramic Imaging Note 10

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)

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

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

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

510(k) Number (if known):

CW5 Continuous Wave Doppler Transducer for use with: Device Name: 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>(Track 1<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 | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | 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) | | | | | | | | |

N = new indication; P = previously cleared by K141846

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

- Note 2 Dynamic TCE Technology
- Note 3 SieClear Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- SieScape Panoramic Imaging Note 10

Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)

- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)

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

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

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

510(k) Number (if known):

Device Name:

Intended Use:

**P4-2 Phased Sector Array Transducer for use with:**

P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ 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 | P | P | P | | P | P | BMDC | Note 2,9 | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,9,16 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | Note 2,9 | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | BMDC | Note 2,9 | |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | BMDC | Note 2,9 | |
| | Adult Cephalic | P | P | P | | P | P | BMDC | Note 2,9 | |
| | 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 | P | P | P | P | P | BMDC | Note 2,7,8,9,13 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,7,8,9,13 | |
| | 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 K121699

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

- Note 2 Dynamic TCE Technology
- Note 3 SieClear
- Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6 Note 7 Stress Echo Imaging
- Note 8 Axius Edge Assisted Ejection Fraction
- Note 9 Clarify Vascular Enhancement Technology
- Note 10 SieScape Panoramic Imaging
- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Contrast Agent Imaging (NX3 Elite only) Note 15
- Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)

(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)_

syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11

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

510(k) Number (if known):

Device Name:

#### VF16-5 Transducer for use with: 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>( Track 1<br>Only) | Specific<br>(Tracks 1 & 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 | Note 2,3,4,9,10,16,17 |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,9,10 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,17 |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,17 |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,17 |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardia…