6420 Ultrasound System

K183191 · Esaote, S.p.A. · IYN · Dec 4, 2018 · Radiology

Device Facts

• Record ID: K183191
• Device Name: 6420 Ultrasound System
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Dec 4, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's 6420 is 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 phase array) and Doppler probes.

Device Story

The 6420 Ultrasound System (MyLabX5) is a compact, mobile diagnostic ultrasound system. It acquires ultrasound signals via connected convex, linear, phased array, and volumetric probes. The system processes these signals to generate 2D, M-mode, Doppler (PW/CW/Color/Amplitude/Tissue Velocity), and harmonic images, displayed on an integrated LCD. It includes advanced features like Strain 2D, Auto NT, and Auto EF. Operated by clinicians in clinical settings, the system assists in diagnostic imaging, biopsy guidance, and needle/catheter placement. The device utilizes a Windows 10 Enterprise LTSB operating system. Output is viewed by the healthcare provider in real-time to inform clinical decision-making, aiding in the diagnosis of various anatomical structures and pathologies.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is based on non-clinical bench testing, including acoustic output measurements (NEMA UD-2, UD-3), biocompatibility, and electrical/mechanical safety (IEC 60601 series).

Technological Characteristics

Compact mainframe ultrasound system with wheels and handle. Supports convex, linear, phased array, and volumetric probes. Modes: 2D, M-Mode, PW/CW/Color/Amplitude Doppler, TVM, TEI, MView, 3D/4D. Connectivity: Wireless. OS: Windows 10 Enterprise LTSB. Safety standards: IEC 60601-1, IEC 60601-1-2, 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/adult cephalic, transvaginal, musculoskeletal, urological, cardiovascular, and peripheral vessel applications. Includes guidance for biopsy and needle/catheter placement.

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

• 6420 — MyLabSix (K161168)
• 6440 — MyLab 9 eXP (K173291)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 4, 2018

Esaote, S.p.A. % Allison Scott Associate Director Navigant Consulting, Inc. 9100 Keystone Crossing, Suite 500 INDIANAPOLIS, IN 46240

Re: K183191

Trade/Device Name: 6420 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 16, 2018 Received: November 19, 2018

Dear Allison Scott:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert 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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# Indications for Use

510(k) Number (if known)

# K183191

Device Name 6420 Ultrasound System

Esaote's 6420 is intended to perform diagnostic general ultrasound studies

including:

Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, 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 mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

| 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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64.20
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

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

LTC Sommer Research Program in Theoretical and Computational Biophysics
& Statistical Mechanics: Breads, Proteins, and Pastries

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[3] Compound Imaging (NWVIEW)

N: Rew Indication, P. Previously cleared Prix B:Added under Appendix B
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L 4-15
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (PD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
|-------------------------------------------------------------------------------------------|--------------------|---|-----|-----|------------------|------------------------------|------------------------|---------------------------------|------------------------------|------------------------|-----------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5, 7, | |
| 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, | |
| 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, 7, | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5, 7, | |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | | P | P: 5, 7, | |
| Other | | | | | | | | | | | |
| Note L.4-15 probe is already cleared via K173291, to be added to 6420 via this submission | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | P | P: 5 | |
| 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 | 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 | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | | | |
| Intraoperative (Abdominal) | | | | | | | | | 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 | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | | | | | | | | | | | |
| Previously cleared via K16-1168 | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P: 5 | |
| Transvaginal | P | P | P | | P | P | P | | P | P: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| Previously cleared via K161168 | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | | | | | | | | | | |
| Fetal | | P | P | | P | P | P | | P | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | P | P | | P | P | P | | P | P: 5 | |
| Transvaginal | | P | P | | P | P | P | | P | P: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | P | P | | P | P | P | | P | P: 5 | |
| Clinical Application | Mode of Operations | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | | P | P | P | P | P | P | P | P | P | P: 5 |
| Fetal | | P | P | P | P | P | P | P | P | P | P: 5 |
| Abdominal | | P | P | P | P | P | P | P | P | P | P: 5 |
| Intraoperative (Abdominal) | | P | P | P | P | P | P | P | P | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | P | P | P | P: 5 |
| Small Organs [1] | | P | P | P | P | P | P | P | P | P | P: 5 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Transvascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | P | P | P | P: 5 |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | P | P | P | P | P | P | P | P | P | P: 5 |
| Musculo-skeletal Superficial [3] | | P | P | P | P | P | P | P | P | P | P: 5 |
| Other (Urological) | | P | P | P | P | P | P | P | P | P | P: 5 |

The L 4-15 probe is already cleared via K173291, to be added to 6420 via this submis

Nr. New indication: P. Previously classe of TDA, E.Added under Appendix B.
[3] Sandia is Adult and Pedia marte in Pasides
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CASE NAME: **PEOPLE VS. RAMIREZ, ESTEBAN**

CASE NUMBER: **BA511751**

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121 Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PV+CEI

[5] Compound Imaging (MyView)

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

SI2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

previously cleared via K16116

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

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[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MyView)

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

SL3116
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Previously cleared via K161.

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

# Pesticide Resistance

## Pesticide Resistance Management Strategies

1. **Scouting and Monitoring:** Regular scouting helps detect pest populations early, allowing for timely intervention and preventing widespread infestations.
2. **Integrated Pest Management (IPM):** IPM combines various control methods, including biological control, cultural practices, and chemical control, to minimize pesticide use and reduce the selection pressure for resistance.
3. **Crop Rotation:** Rotating crops can disrupt pest life cycles and reduce the reliance on specific pesticides.
4. **Pesticide Rotation:** Rotating pesticides with different modes of action can prevent pests from developing resistance to a single class of chemicals.
5. **Mixtures and Combinations:** Using pesticide mixtures or combinations with different modes of action can broaden the spectrum of control and reduce the risk of resistance development.
6. **Proper Application:** Applying pesticides at the correct dosage, timing, and coverage ensures effective pest control while minimizing exposure to non-target organisms.
7. **Resistance Monitoring:** Regularly monitoring pest populations for resistance to commonly used pesticides can help detect resistance early and guide management decisions.
8. **Education and Training:** Educating farmers and applicators about pesticide resistance and best management practices is crucial for promoting responsible pesticide use and preventing resistance development.

[2] Cardiac is Adult and Pediatric.

[C] MUSCULO SKELETAL - NERVE BLOCK

RECOMBINANT MURINE IL-12 P70 ELISA KIT

[3] Compound Imaging (MRCIW)

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# SE3133
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Previously cleared via K1611

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

ORGANIZATIONAL STRUCTURE

SOMERSET AND PULASKI COUNTIES

EAST BERNSTADT, LONDON, HYDEN, HAZARD, PIKEVILLE, PRESTONSBURG, AND PAINTSVILLE DISTRICTS

SPECIALIZED AND RESTRICTED FACILITIES

[2] Cardiac is Adult and Pediatric.

[RC] MUSCOLO SCALENO - Active BLOCK

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

[5] Compound Imaging (Mrview)

Ni New Hillering in New Business in Film Bidded under Appenda B
(3) Musikal Pickel Billeria (2008)
(3) Musikal Pickel Piller (2006)
(4) Comment Mark (1978) (1994) (2004) (20

7/3D/4D

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# TLC 3-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

reviously cleared via K161168

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

Organicles
Restoration

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MVIEW)

11 New indestion in Pevlensive in Finalded under Abondise B
13 Marcula Selection Marceles Bronder Armendis B
13 Marcula Securit Andre Electric Production And
10 Dominera

7I3D/4D

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

# IIH 6-18
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

reviously cleared via K161168

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] Muse

# SOS Children's Villages International

**Hermann-Gmeiner-Strasse 51, 6020 Innsbruck, Austria**

www.sos-childrensvillages.org

[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] Friday Cardia Cardiac (2017)
[6] Includes contrast (CnTT) in Adult Cardiac for left ventricle opacification and
visualization of the left ventricular endocardial border

[7] 3D/4D

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

| Esaote |
|---------|
| 6420 |
| Upgrade |
| 510(k) |
| Special |

ILL 4-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human | Mode of One

| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) |
|--------------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | P | P | P | P | P | P | P | P | P | P: 5 |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5 |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P: 5 |
| Small Organs [1] | P | 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 | P: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>[3] | P | P | P | P | P | P | P | P | P | P: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | P | P | P: 5 |
| Other (Urological) | | | | | | | | | | |
| Mode of Operations | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic 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 Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
| Previously cleared via K161168 | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | P | P | P | | P | P | P | | P | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | P | | P | P | P | | P | P: 5, 7 |
| Transvaginal | | | P | | P | P | P | | P | P: 5, 7 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | | | P | | P | P | P | | P | P: 5, 7 |

Previously cleared via K1611

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

THE SORCERER'S BREWERY, HYDRATION AND PESTICIDES

[2] Cardiac is Adult and Pediatric .

31. MUSCULO SKELETAL - Nerve Block

CONSORT, THOMAS, & CHIN, LLP

1. Compound imaging (MVIEW)
2. Includes contrast (C-Tm) in

N: New Indivation I Frances designifia
Film March Station Articles Maria Maria Maria Marian Baranda B
Filiana Seathing September 2014 Provinsia Provincial Production and Andr

.713D/4D

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

LLP 4-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Previously cleared via K161

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

Test Articles

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound images (of Mrew)

N New Hallential N Previously Provinsialed under Appendes B
Film March President Provincial Provincial Propendia B
Privation Article Marie Maria PD
IST Computer of Marin Marc

13D/4D

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

SB3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human | Mode of One

Previously cleared via K1611

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

Abstract. Articles are presented on hydrodynamics, including: the hydrodynamics of the free surface; the hydrodynamics of ship propellers; and the hydrodynamics of ship rudders.

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[FCI] Compound Imaging (MVIEW)

N: Rew Indication, P. Previously electronic Propendix E
[] Santlined Particular Provinsia Propendix E
[] Santlined moter and Provinces Provincial Propendia Bond
[] Dombinary

713D/4D

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

| Esaote |
|---------|
| 6420 |
| Upgrade |
| 510(k) |
| Special |

SL3323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color 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 | | | | | | |…