WS80A Diagnostic Ultrasound System

K173513 · Samsung Medison Co., Ltd. · IYN · Feb 20, 2018 · Radiology

Device Facts

• Record ID: K173513
• Device Name: WS80A Diagnostic Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Feb 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.

Device Story

WS80A is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in modes including B-mode, M-mode, Color/Power Doppler (including S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Used in clinical settings by healthcare professionals to measure anatomical structures and perform diagnostic analysis. The system provides real-time acoustic output display (mechanical/thermal indices). Output is viewed on the system display to assist clinicians in diagnosis and clinical decision-making, potentially benefiting patients through non-invasive imaging and analysis.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and electrical/mechanical safety testing.

Technological Characteristics

Mobile, software-controlled diagnostic ultrasound system. Employs pulsed Doppler, B-mode, M-mode, and various Doppler/harmonic imaging modes. Includes 3D/4D imaging and Elastoscan. Materials evaluated for biocompatibility. Complies with electrical and physical safety standards. Connectivity includes digital image capture and reporting. Software-controlled analysis packages.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, gynecology, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac (adult/pediatric), and peripheral vessel applications. Used in adult, pediatric, and neonatal patient populations.

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

• WS80A Diagnostic Ultrasound System (K171070)
• RS80A Diagnostic Ultrasound System (K171048)
• Noblus™ Ultrasound Diagnostic System (K142368)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co., Ltd. Ms. Ji Yea Lee Regulatory Affairs Specialist 42, Teheran-ro 108-gil Seoul. 06176 SOUTH KOREA

February 20, 2018

# Re: K173513

Trade/Device Name: WS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 22, 2017 Received: November 24, 2017

Dear Ji Yea Lee:

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 (OS) 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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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'Hara For

Robert A. 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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510(k) Number (if known)

### K173513

Device Name WS80A Diagnostic Ultrasound System

### Indications for Use (Describe)

The WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: WS80A Diagnostic Ultrasound System

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

| | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
|----------------|-------------------------------|---|---------------------------------------------------|-----|-----|----------|-----------|--------------------------------------|--|--|--|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | | | |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 3,4, 5, 6, 7, 8, 9, 11, 12 | | | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9,10, 11, 12 | | | |
| | Intra-operative (See Note 6) | P | P | P | | P | Note 1 | Note 7, 9, 11 | | | |
| | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 9, 11 | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | | |
| ంగ్ర<br>Other | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 4, 6, 7, 8, 9, 11 | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12 | | | |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7 | | | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Notes 7 | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | |
| | Intra-luminal | | | | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 7,8, 9, 11, 12 | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7 | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | |
| Vessel | Other (spec.) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: SC1-6 for use with WS80A

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| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------------|--|--|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | | | |
| & Other | Pediatric | | | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | | | |
| | Intra-luminal | | | | | | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | | | | |

### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW. B+PD+CW. B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: C2-6 for use with WS80A

| | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------|--|
| General<br>(Track I only) | Specific<br>Tracks I & III) | 0 | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec. | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | C | O | D | | D | Note | Notes 2, 4, 7, 8, 9, 11 | |

{5}------------------------------------------------

| | Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 |
|--------------------------|------------------------------|---|---|---|---|--------|----------------------|
| | Intra-operative (See Note 6) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | |
| | Pediatric | | | | | | |
| | Small Organ (See Note 5) | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | |
| | Other (spec.) | | | | | | |

### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

- Note 12: ElastoScan Note 13: Includes Urology/Prostate
Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: E3-12A for use with WS80A

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|----------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 8, 7, 9 |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 |
| | Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+DPH+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

- Note 4: Color M-mode
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

- Note 7: Tissue Harmonic Imaging (THI)
- Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

- Note 10: Includes Renal, Gynecology/Pelvis
- Note 11: Panoramic imaging
- Note 12: ElastoScan

Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VR5-9 for use with WS80A

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| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|---------------------|--|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9 | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | |
| | Intra-operative (See Note 6) | | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | | |
| & Other | Pediatric | | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | | |
| | Intra-luminal | | | | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | | | |

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW. B+PD+CW. B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: L3-12A for use with WS80A

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |

{8}------------------------------------------------

| | Abdominal (See Note 10) | P | P | P | P | Note 1 | Notes 2, 4, 6, 7, 9, 11 |
|---------------|------------------------------|---|---|---|---|--------|----------------------------|
| | Intra-operative (See Note 6) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | |
| & Other | Pediatric | P | P | P | P | Note 1 | Notes 2, 4, 6, 7, 9, 11 |
| | Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| Vessel | Other (spec.) | | | | | | |

### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

> Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-13 for use with WS80A

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|----------------------|-------------------------------|---|---------------------------------------------------|-----|-----|----------|-----------|---------|--|--|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | | |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | |
| Other<br>ళ | Pediatric | | | | | | | | | |

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

| | Small Organ (See Note 5) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 |
|------------|-----------------------------|---|---|---|---|--------|----------------------------|
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | |
| | Other (spec.) (See Note 13) | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Cardiac Adult | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| Vessel | Other (spec.) | | | | | | |

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PP!, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

### 510(k) No.:

Device Name: V4-8 for use with WS80A

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 4, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |

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

| | Trans-urethral | | | | |
|------------|-----------------------------|--|--|--|--|
| | Trans-esoph. (non-Cardiac) | | | | |
| | Musculo-skel. (Convent.) | | | | |
| | Musculo-skel. (Superfic.) | | | | |
| | Intra-luminal | | | | |
| | Other (spec.) (See Note 13) | | | | |
| Cardiac | Cardiac Adult | | | | |
| | Cardiac Pediatric | | | | |
| | Trans-esophageal (Cardiac) | | | | |
| | Other (spec.) | | | | |
| Peripheral | Peripheral vessel | | | | |

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, DuallQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

## Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with WS80A

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|---------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |

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

| | Other (spec.) (See Note 13) | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 |
|------------|-----------------------------|---|---|---|---|--------|----------------------|
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | |
| | Other (spec.) | | | | | | |
| Peripheral | Peripheral vessel | | | | | | |
| Vessel | Other (spec.) | | | | | | |

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

### 510(k) No.:

### Device Name: CA1-7A for use with WS80A

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|--------------------------|--|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 13 | | | |
| | Intra-operative (See Note 6) | | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | | |
| &<br>Other | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | |
| | Small Organ (See Note 5) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | |
| | Intra-luminal | | | | | | | | | | |
| | Other (See Note 13) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | | |
| | Other (spec.) | | | | | | | | | | |

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

| Peripheral | Peripheral vessel | | | | | | |
|------------|-------------------|--|--|--|--|--|--|
| Vessel | Other (spec.) | | | | | | |

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging) Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-8A for use with WS80A

Intended Use: Diagnostic ultrasound imaqinq or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | | |
| & Other | Pediatric | | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (See Note 13) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | | |

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, ,

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

B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging

- Note 12: ElastoScan
- Note 13: Includes Urology/Prostate

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: CF4-9 for use with WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | |
|---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 8, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| &<br>Other | Pediatric | P | P | P | P | P | Note 1 | Notes 8, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 8, 9, 11 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 8, 9, 11 |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+D, B+C+PW, B+D+PW, B+DPD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

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

### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

### 510(k) No.:

Device Name: LA3-16A for use with WS80A

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

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|----------------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | |…