6400 Ultrasound System (MyLabX6, MyLabX7)

K190989 · Esaote, S.p.A. · IYN · May 10, 2019 · Radiology

Device Facts

• Record ID: K190989
• Device Name: 6400 Ultrasound System (MyLabX6, MyLabX7)
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: May 10, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

Device Story

The 6400 Ultrasound System (MyLabX6, MyLabX7) is a mobile, cart-based diagnostic ultrasound system. It processes inputs from various mechanical and electronic probes (convex, linear, phased array, Doppler, volumetric) to generate B-mode, M-mode, Doppler, Color Flow, and 3D/4D images. Used in clinical settings by healthcare professionals, the system assists in diagnostic imaging, biopsy guidance, and needle/catheter placement. New capabilities include Auto NT (automatic nuchal translucency measurement), MicroV (low-speed flow detection), QPack (time/intensity curve quantification), and 4D STIC. The system features a capacitive touchscreen, full-screen mode, and runs on Windows 10. Output is displayed on an integrated LCD for real-time clinical assessment, aiding in diagnosis and procedural guidance.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing conforming to IEC and NEMA standards.

Technological Characteristics

Mainframe ultrasound system with LCD display and capacitive touchscreen. Supports convex, linear, phased array, and volumetric probes. Connectivity includes wireless capability. Operates on Windows 10 Enterprise LTSB. Software includes B-mode, M-mode, Doppler, Color Flow, TEI, MView, TVM, 3D/4D, and Elastosonography. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, NEMA UD-2, NEMA UD-3.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intraoperative, laparoscopic, pediatric, small organ, neonatal, cephalic, transvaginal, musculoskeletal, urological, cardiovascular, and peripheral vascular applications. Includes needle/catheter guidance and peripheral nerve blocks.

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

• 6400 – MyLabSeven (K161359)

Reference Devices

• 6420 - MyLabX5 (K183191)
• 6440 – MyLab9 (K173291)

Submission Summary (Full Text)

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May 10, 2019

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Esaote, S.p.A. % Piet de Jong Regulatory Affairs Manager Via Enrico Melen 77 Genova 16152 ITALY

Re: K190989

Trade/Device Name: 6400 Ultrasound System (MyLabX6, MyLabX7) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 2, 2019 Received: April 15, 2019

Dear Piet de Jong:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

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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## Indications for Use

510(k) Number (if known) K190989

Device Name

6400 Ultrasound System (MyLabX6 - MyLabX7)

#### Indications for Use (Describe)

MyLabX6 and MyLabX7 are intended to perform diagnostic general ultrasound studies including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculosketal (Superficial), Urological,

Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

| Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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#### 6400

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

| Clinical Application | Mode of Operations | | | | | | | | | Other (specify) |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | P: 5 |
| Adult Cephalic | P | P | P | P | P | P | P | | P | P: 5 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P [7] | P: 5 |
| Transesophageal (Cardiac) [2] | P | P | P | P | P | P | P | P | P | P: 5 |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Transvaginal | P | P | P | P | P | P | P | | P | P: 5, 6 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 |
| Laparoscopic | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5, 6 |

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008, K161359 and to be cleared with this submission

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#### AC2541

| Clinical Application | | Mode of Operations | | | | | | | | |
|-------------------------------------|---|--------------------|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared viaK142077 and K161359

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#### IH 6-18

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

{6}------------------------------------------------

#### IL 4-13

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | P | P: 5 |
| Abdominal | P | P | P | P | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | P | P | P | P | | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K161359

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

#### IOE323

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|------------------------|--------------|-------------------------------|------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Tissue Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

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

#### IOT342

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal<br>Superficial [3] | P | P | P | | P | P | P | | P | P: 5 |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008 and K161359

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

#### L3-11

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

| | Mode of Operations | | | | | | | | | |
|---------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5, 7 |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 8, 10 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 7 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 7, 8 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, 7 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 7 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 8 |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | | P | P: 5, 7, 8 |
| Other | | | | | | | | | | |

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

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

#### L4-15

| | Mode of Operations | | | | | | | | | |
|---------------------------------|--------------------|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(PD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, 10, 11 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5, 7, 11 |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5, 7, 11 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | P: 5, 7, 11 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5, 7, 11 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, 8, 11 |
| Musculo-skeletal<br>Superficial | P | P | P | | P | P | P | | P | P: 5, 7, 8, 11 |
| Other | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

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

#### LP 4-13

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | P | P | | P | P: 5 |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K142008, K161359 and to be cleared with this submission

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

#### mC 3-11

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | |
| Small Organs [1] | P | P | P | P | P | P | P | | P | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | | P | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

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

#### P 1-5

| | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | | P | P | P | | P | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | 7 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (OB-Fetal) | P | P | P | | P | P | P | | P | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles [2] Cardiac is Adult and Pediatric [3] Musculo Skeletal - Nerve Block [4] Combined modes are: B+M+PW+CW+CFM+PD [5] Compound Imaging (Mview) [6] 3D/4D [7] Includes contrast (CnTI) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

Previously cleared via K173291 and to be cleared with this submission

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

#### P 2-9

| Clinical Application | Mode of Operations | | | | | | | | | |
|-------------------------------------|--------------------|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | 7 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal<br>Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |

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

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFM+PD

[5] Compound Imaging (Mview)

[6] 3D/4D

[7] Includes contrast (CnTl) in Adult Cardiac for left ventricle opacification and visualization of the left ventricular endocardial border

To be cleared with this submission

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

#### P2 5-13

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude<br>Doppler (PD) | Combined [4] | Tissue Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|-------------------------------------|---|---|-----|-----|---------------|---------------------------|--------------|----------------------------------|---------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2]…