HS50/HS60 Diagnostics Ultrasound System

K192505 · Samsung Medison Co., Ltd. · IYN · Dec 12, 2019 · Radiology

Device Facts

• Record ID: K192505
• Device Name: HS50/HS60 Diagnostics Ultrasound System
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal(Cardiac) and peripheral vessel.

Device Story

HS50/HS60 are mobile, software-controlled diagnostic ultrasound systems. They acquire ultrasound data via various transducers and display it in multiple modes: B, M, Color M, Anatomical, Color Doppler, PW/CW Spectral Doppler, TDI, TDW, Power Doppler, ElastoScan, 3D/4D/XI STIC, Dual, Combined, Simultaneous, and Zoom. Used by healthcare professionals in clinical settings to measure anatomical structures and perform diagnostic analysis. The system provides real-time acoustic output display (mechanical/thermal indices). New features include 2D Follicle and LaborAssist, which provide functionality similar to existing predicate features. The system supports biopsy guidance and runs on a Windows 10 OS. Output is used by clinicians to inform diagnostic decision-making.

Clinical Evidence

No clinical studies were required to demonstrate substantial equivalence. Safety and effectiveness were established through non-clinical testing, including acoustic output measurement, biocompatibility, software validation, and thermal/electrical/electromagnetic safety testing in compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004).

Technological Characteristics

Mobile diagnostic ultrasound system; Windows 10 OS; supports multiple imaging modes (B, M, Doppler, 3D/4D, ElastoScan). Transducers include various phased, convex, and linear arrays. Connectivity includes digital image capture and reporting. Biocompatible materials used for patient-contact components. Acoustic output meets NEMA UD 2-2004 standards. Software-controlled signal processing for image reconstruction and measurement.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel applications.

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

• HS50/HS60 Diagnostic Ultrasound System (K181336)
• VOLUSON E Series Voluson E6, Voluson E8, Voluson E10 (K181985)

Submission Summary (Full Text)

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December 12, 2019.

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

SAMSUNG MEDISON CO., LTD % Scully Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gaungwon-do 25108 REPUBLIC OF KOREA

### Re: K192505

Trade/Device Name: HS50/HS60 Diagnostics 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, 2019 Received: November 25, 2019

Dear Scully Kim:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K192505

Device Name

HS50 / HS60 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound maging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and peripheral vessel.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) No.:

Device Name: HS50/HS60 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<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 | | Note 15 | Note 1 | Note 2,3,4, 7, 8, 9, 11 |
| | | Abdominal (See Note 10) | P | P | P | P | Note 15 | Note 1 | Note 2,6, 7, 8, 9, 11, 12, 16 |
| | | Intra-operative (See Note 6) | | | | | | | |
| | | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | | Laparoscopic | | | | | | | |
| | | Pediatric | P | P | P | P | Note 15 | Note 1 | Note 2, 6, 7, 8, 9, 11 |
| | | Small Organ (See Note 5) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 |
| | | Neonatal Cephalic | P | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 |
| | | Adult Cephalic | P | P | P | P | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 |
| | | Trans-rectal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 11, 12 |
| | | Trans-vaginal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 11, 12 |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Cardiac) | | | | | | | |
| | | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 |
| | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 |
| | | Intra-luminal | | | | | | | |
| | | Other (See Note 13) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 11, 12 |
| | Cardiac | Cardiac Adult | P | P | P | P | Note 15 | Note 1 | Note 4, 7, 14, 17 |
| | | Cardiac Pediatric | P | P | P | P | Note 15 | Note 1 | Note 4, 7, 14, 17 |
| | | Trans-esophageal (Cardiac) | P | P | P | P | Note 15 | Note 1 | Note 4, 7, 14, 17 |
| | | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | | Peripheral vessel | P | P | P | P | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 |
| | | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+C+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)
- 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
- Note 14: Tissue Doppler Imaging (TDI)
- Note 15: Color Doppler includes Power (Amplitude) Doppler
- Note 16: Contrast Note 17: Strain+

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510(k) No.:

Device Name: LA3-14AD for use with HS60/ HS50

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 Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | |
| | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+CW, B+C, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

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 Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast

Note 17: Strain+

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510(k) No.:

Device Name: CA1-7AD for use with HS50/HS60

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 | | Note 15 | Note 1 | Notes 2, 7, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11, 16 |
| | 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.) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | 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 K181336; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast

Note 17: Strain+

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510(k) No.:

Device Name: CF4-9 for use with HS50/HS60

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 (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal/Obstetrics (See Note 3) | P | P | P | | Note 15 | Note 1 | Notes 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Notes 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging & Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | Note 15 | Note 1 | Notes 6, 9, 11 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 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 Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Notes 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: ER4-9 for use with HS50

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 Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9 |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 |
| | Trans-vaginal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) (See Note 13) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Note 1: B+M, B+CW, B+C, B+C, B+PD, B+Elastoscan, B+C+PW, B+DD+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

Note 16: Contrast

Note 17: Strain+

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

510(k) No.:

Device Name: LA3-16A for use with HS50/HS60

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 | | Note 15 | Note 1 | Note 2,7,9,11,12 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2,7,9,11,12 | |
| | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | |
| | Other (spec.) | | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: LA3-16AI for use with HS60

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<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal ( <i>See Note 3</i> ) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other ( <i>See Note 13</i> ) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Note 6, 7, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

- Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: LA2-9A for use with HS60

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 Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: PE2-4 for use with HS50

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 | Note 15 | Note 1 | Note 7 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging & Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | Note 15 | Note 1 | Note 7 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 14, 17 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 14, 17 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: PA3-8B for use with HS50/HS60

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 Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | P | Note 15 | Note 1 | Note 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | Note 15 | Note 1 | Note 6, 7 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | Note 15 | Note 1 | Note 7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 14,17 |
| | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 14, 17 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

- Note 14: Tissue Doppler Imaging (TDI)
Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: PE2-4 for use with HS50/HS60

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 Imaging<br>& Other | Fetal/Obstetrics (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | P | P | P | P | Note 15 | Note 1 | Note 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | Note 15 | Note 1 | Note 7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 14,17 |
| | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 14, 17 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K181336; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+CW, B+C+PW, B+PD+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)

- 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

Note 14: Tissue Doppler Imaging (TDI)

Note 15: Color Doppler includes Power (Amplitude) Doppler

- Note 16: Contrast Note 17: Strain+

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

510(k) No.:

Device Name: CV1-8AD for use with HS50/HS60

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 | | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 |
| | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 |
| | Intra-operative (See Note 6) |…