Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions "Auto NT option" and "Auto EF option". While these could potentially utilize AI/ML for automated measurements (Nuchal Translucency and Ejection Fraction), the summary does not explicitly state that AI/ML is used for these features. Without further information, it's not possible to definitively confirm the presence of AI/ML.

Therapeutic

No.
The device is intended to perform diagnostic general ultrasound studies and guide biopsy and needle/catheter placement, not to provide therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to perform diagnostic general ultrasound studies".

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "compact mainframe system equipped with wheels" and includes hardware components like a display, control panel, and connections for probes. It is an ultrasound system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for performing "diagnostic general ultrasound studies" and providing "imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters". This describes an imaging device used in vivo (within the living body) to visualize internal structures.
Device Description: The description details an ultrasound system with probes, a display, and various imaging modes. This is consistent with an ultrasound machine used for medical imaging.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to obtain diagnostic information. The provided text does not mention any analysis of biological specimens or any components typically associated with IVD testing (reagents, analyzers for specimens, etc.).

Therefore, the Esaote 6420 is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

IYN, IYO, ITX

Device Description

The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle.

The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

6420 is equipped with wireless capability.

Model 6420 was previously cleared via K161168.

The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below:

1. Management of Strain 2D.
1. Addition of Auto NT option.
1. Addition Auto EF option
1. Management of probe L 4-15.
1. Addition of Full screen option.
1. Operative system Windows 10

The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No clinical tests were performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161168

Reference Device(s)

K173291

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

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
[1] Samulaci Samaria Previous Provincial Provincial Propertix B
[1] Samulad material (1974) (1974-1914)

1713D/4D

4

조합병원 등 중국 공급 업체 및 공급 업체 및 공급 및 공급 및 공급 및 공
។ ។ ៣ ។ ហ ហ ក ល ១ ១ ១ ១ ជ ជ ព ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។

5

10(k)

9
Special















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6420





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1

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
Doppler	Amplitude
Doppler
(AD)	Combined
[4]	Color Velocity
Mapping (TVM)	Harmonic
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
[3] Sanding Skatola - Repres Deco.
[1] Componed Imag

SUPERIOR COURT OF CALIFORNIA, COUNTY OF LOS ANGELES

CASE NAME: PEOPLE VS. RAMIREZ, ESTEBAN

CASE NUMBER: BA511751

NOTICE OF MOTION AND MOTION TO DISMISS BASED ON PROSECUTORIAL MISCONDUCT AND REQUEST FOR EVIDENTIARY HEARING

121 Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MyView)

ql3D

[71 CMM]

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

US Senate includes Bennet, Hickenlooper and Gardner, thy said.

[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)

N New Indivation in Nevelende in Priders
(4) Sandlia e Marce Brander (2008).
(4) Gardler Marce Presidential Province
(4) Campionel more at Personalis (2008).
(1) Dombridge (2

FLORIDA
71-2R/4R
Standardization in the ICIS

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

Scouting and Monitoring: Regular scouting helps detect pest populations early, allowing for timely intervention and preventing widespread infestations.
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.
Crop Rotation: Rotating crops can disrupt pest life cycles and reduce the reliance on specific pesticides.
Pesticide Rotation: Rotating pesticides with different modes of action can prevent pests from developing resistance to a single class of chemicals.
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.
Proper Application: Applying pesticides at the correct dosage, timing, and coverage ensures effective pest control while minimizing exposure to non-target organisms.
Resistance Monitoring: Regularly monitoring pest populations for resistance to commonly used pesticides can help detect resistance early and guide management decisions.
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)

N: New Indicated on Provinces of Provinsioner Appendix E
[] Samulla Partings Maria Province Propendia B
[]] Ramula mater-stream (* 1978)
[1] Comment mast (* 1941) Proveder an

713D/4D

8

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

9

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
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 | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P: 5 |
| Laparoscopic | | | | | | | | | | |
| 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) | | | | | | | | | | |
| 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 .

MUSCULO SKELETAL - Nerve Block

CONSORT, THOMAS, & CHIN, LLP

Compound imaging (MVIEW)
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

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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
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic	P	P	P		P	P	P		P	P: 5
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
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 Superficial [3]	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
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)
	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
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 [3]	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)
Ophthalmic	P	P	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P
Small Organs [1]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	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	P
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P
Other (Urological)
Previously cleared via K161168
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
	Mode of Operations
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)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5
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	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P		P	P: 5
Other (Urological)	P	P	P	P	P	P	P		P	P: 5
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
Fetal	P	P	P	P	P	P	P	P	P	P: 5
Abdominal
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	P	P: 5
Laparoscopic
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
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other
Ophthalmic	P	P	P	P	P	P	P	P	P	P
Fetal	P	P	P	P	P	P	P	P	P	P
Abdominal	P	P	P	P	P	P	P	P	P	P
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organs [1]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac [2]	P	P	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	P	P
Laparoscopic
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P
Other (Urological)
Previously cleared via K161168

Clinical Application	Mode of Operations								Other (specify)
	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (AD)	Combined [4]	Color Velocity Mapping (TVM)		Harmonic Imaging (TEI)
Ophthalmic
Fetal	P	P	P		P	P			P	P: 5
Abdominal	P	P	P		P	P	P		P
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 [3]
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
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	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)
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]	P	P	P	P	P	P	P	P	P	P: 5
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 [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)
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	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]	P	P	P		P	P	P		P	P: 5
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)
Clinical Application		Mode of Operations							Color Velocity
Mapping (TVM)	Harmonic
Imaging (TEI)	Other (specify)
		B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
(AD)	Combined
[4]
Ophthalmic		P	P	P	P	P	P	P		P
Fetal		P	P	P	P	P	P	P		P
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]
Neonatal Cephalic		P	P	P	P	P	P	P		P
Adult Cephalic		P	P	P	P	P	P	P		P
Cardiac [2]		P	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
Musculo-skeletal Superficial [3]
Other (Urological)
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:						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
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)				P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic				P
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
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
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
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Previously cleared via K161168
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
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
Fetal	P	P	P		P	P	P		P	P: 5, 7
Abdominal	P	P	P		P	P	P		P	P: 5, 7
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
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
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
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
Laparoscopic
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
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric		P	P	P	P	P	P	P	P	P: 5
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
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	P	P: 5
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 Superficial [3]	P	P	P	P	P	P	P	P	P: 5
Other (Urological)

Previously cleared via K16116

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

The Superior, Stronger, Smarter, Faster, and Nicer Test for Breasts, Thighs, and Features

[2] Cardiac is Adult and Pediatric.

[3] MUSCULO SKELETAL - Nerve Block

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

(c) Compound mEq/mLs (M/VIEW)
(d) Includes contrast (C-T) 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

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15

SL3235

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

[2] Cardiac IS Adult and Pediatric.

31. MUSCULO SKELETAL - NERVE BLOCK
P.M. DIV.

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

(a) Compound images (MICM)
(b) Includes contrast (CM) in

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

.713D/4D

16

SL2325
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

isly cleared via K161

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

SUPERIOR COURT OF CALIFORNIA, COUNTY OF LOS ANGELES
STREET ADDRESS: 111 N. HILL STREET
MAILING ADDRESS: 111 N. HILL STREET
CITY AND ZIP CODE: LOS ANGELES, CA 90012
BRANCH NAME: CENTRAL DISTRICT
PLAINTIFF/PETITIONER: WELLS FARGO BANK, N.A.
DEFENDANT/RESPONDENT: VICTORIA PITTS, ET AL.
DOES 1 TO 10

REQUEST FOR DISMISSAL
CASE NUMBER:
21STCP00163

ATTORNEY OR PARTY WITHOUT ATTORNEY (Name, State Bar number, and address):
JESSICA M. PALMER (SBN 278863)
ALDRIDGE PITE, LLP
4375 JUTLAND DRIVE, SUITE 200
SAN DIEGO, CA 92117
TELEPHONE NO.: (619) 590-9100
E-MAIL ADDRESS: litigation@aldridgepite.com
ATTORNEY FOR (Name): WELLS FARGO BANK, N.A.
FAX NO.: (619) 590-1385

TO THE CLERK: Please dismiss this action as follows:
a. ☐ With prejudice ☐ Without prejudice
b. ☐ Complaint ☐ Petition ☐ Cross-complaint ☐ Other (specify):
(Complete in all cases.)
Date: 08/03/2023

JESSICA M. PALMER
(TYPE OR PRINT NAME OF ☐ ATTORNEY ☐ PARTY WITHOUT ATTORNEY)

If dismissal requested is of specified parties only of specified causes of action only, or of specified cross-complaints only, so state.

FOR CLERK'S USE ONLY

Dismissal entered as requested on (date):
☐ Dismissal not entered as requested for the following reasons (specify):
a. ☐ Attorney or party without attorney notified on (date):
b. ☐ Attorney or party without attorney not notified. Filing party failed to provide
☐ an address ☐ a stamped envelope ☐ other:
Date:
Clerk, by
, Deputy

Form Adopted for Mandatory Use
Judicial Council of California
DISMISSAL
Code of Civil Procedure, §§ 581 et seq.
www.courts.ca.gov
DIS-010 [Rev. January 1, 2016]

[2] Cardiac is Adult and Pediatric

[31] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MIC)

Ni Namalionin Li Breigals (1949) Sidded under Appeada E
(3) Murdia Palandi Parti Provinsia (2004) Sidded under Appenda E
(3) Murdian Partis Provincia (2004)
(2) Pombound muse

1/3D/4D

17

SL3332

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

Filiated in the the time of the states of the same of country of the first

Other (specify

ഹം പാ
പ്പ് പ്ര

ਤ : ਜੂ
ਤੇ : ਜ

P: 5

P: 5 P: 5

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

Realistic
Studies, Inc.
and
Thyroid
Breast
Cancer
Trials

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

N: New Indiedronie Nationale oleanski
|| Satuluar 2018 || Alientes || Patientes || Saturales || Saturals B
|| Satulum | Archives | Previous | Previous | Particle opedificatio

413D/4D

18

SC3421

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

Previously cleared via K1611

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

UT Southwestern Medical Center
5323 Harry Hines Blvd., Dallas, TX 75390
O'Donnell Brain Institute

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MVIEW)

11 New manasana in mewonese (2017 Elizada umer American m
(2) Marcule Selection Marceleste
(2) Gardina Sedente Marce Metrop
(2) Caralla Sected Antone Metro Medicale Managemen

Z13R/4D

Reconstruction of the zero-frequency

19

AC2541

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

via K16 ed

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

HYDROCARBON SOLVENTS, N.O.S. (NAPHTHA SOLVENT) UN1268, PG II, MARINE POLLUTANT, FLASH POINT BELOW 23 DEGREES CELSUS

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging (MView)

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺘﺤﻘﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ

413D/4D

20

Mode of Operations SC3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Made of Cas

(specify)

b
ப்பு பல
ப்ப

ம் மாவட்டம்
கிருக்கு புக

P: 5

P: 5 P: 5

6. Circular permutation.

Definition 6.1. A circular permutation of
$$n$$
objects is an arrangement of the objects in a circle.

Example 6.2. Suppose we have four objects
$$a, b, c, d$$
and we want to arrange them in a circle. Then the following are considered the same circular permutation:

$$a\rightarrow b\rightarrow c\rightarrow d\rightarrow a$$

$$b\rightarrow c\rightarrow d\rightarrow a\rightarrow b$$

$$c\rightarrow d\rightarrow a\rightarrow b\rightarrow c$$

$$d\rightarrow a\rightarrow b\rightarrow c\rightarrow d$$

Theorem 6.3. The number of circular permutations of
$$n$$
distinct objects is
$$(n-1)!$$
.

Proof. Fix one of the
$$n$$
objects. Then there are
$$(n-1)!$$
ways to arrange the remaining
$$n-1$$
objects in a line. Each of these arrangements corresponds to a unique circular permutation.

CITY OF NEW YORK
DEPARTMENT OF BUILDINGS
OFFICE OF THE BOROUGH SUPERVISOR
EAST SIDE BRANCH, MANHATTAN

[2] Cardiac is Adult and Pediatric

MUSCULO SKELETAL, NERVE BLOCK
P. IV. REG. DR.

[5] Compound Imaging, IMVIEW

11 New Indication Printers County Courter Archites
13 Music Satural Presidente
13 Curano Sadanti Marce Marco Metro
13 Curano Adam Piris Aliento Merce Metricle openification

4/3D

21

SE3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human | Mode of Pro

Previously cleared via K1611.

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

Organized by the
Hydrocarbon Processing
Technical Conference

[2] Cardiac is Adult and Pediatric .

[3] MUSCULO SKELETAL - NERVE BLOCK

COMBINED PROCESS STEPS:
B+K+P+M+C+Y+LC+LM+OR+G

ther compound missing (review)
(K) Includes contrast (CT) 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

22

AL2442

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

via K16 ed

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

I.I. Small Volume Breast, Thyroid and Testicles

[2] Cardiac is Adult and Pediatric.

R] MUSCULO SCAPULAR - NERVE BLOCK

Combined modes are: B, B+M, CH, CH+M

Compounding masking (MVICW)
Includes contrast (CRT) in A

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13 Museum Steeller Stearer
13 Museum Steelle Arterne Marce 2014 PD
13 Museum e Skeller Merce Metro Provincials open

$\mathbb{R}^{13D/4D}$

23

SL1543

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

via K16

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

Articles
Organelles

2] Cardiac is Adult and Pediatric.

[3] Muscle Skeletal - Nerve Blood

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

[5] Compound Imaging (M-view)

Now Indiestion In Frances of Fridaded under Aprendes E
(3) Murdia Skeun Streams (2007) Ericles (2006)

7L3D/4D

24

SP2730
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows

11 New indiestion in Peedanaly Electric News.
13 Cardina Shault and Creating Crained Crainer Appendia E
13 Cardina Shault and Personal Production
13 Continuer March Printin

THE Smallest Speakers Include:

1" Soft Dome Tweeters
3.5" Polypropylene Mid-Woofer
Rear Ported Enclosure
Gold Plated Binding Posts
Acoustically Transparent Grill
and are priced at $149.99/pair, last.

[2] Cardiac is Adult and Pediatric

141 Combined modo oro: R+M+RW+CW+CE

TAT

CONSIDER: WORSES, B, N, P, R, CI

Vector left
Vector right
Triangle
Rectangle
Circle
Ellipse
Star
Pentagon
Hexagon
Heptagon
Octagon
Nonagon
Decagon

the official b
order

visualization.

713D/4D

25

S2MCW

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

Other (Urological)
Previously cleared via K16116

N: New indication, P. Reviews); Chrysland Chirosoft Cristian
[3] Carall. Of Personal, Chrysid and Tealler
[2] Carall. Of Personal, Thyrod and Tealiste
[2] Carama Carleral Pro

US 10-year nominal Treasury yields and Breakeven Inflation Expectations, 5-year, 5-year forward
Source: Bloomberg Finance L.P.

2] Cardiac [Adult and Pediatric]

INSULATED SKIRTING REINFORCEMENT BLOCK

CALA 1:1 Model now available on CAD details

[EC] Compound Imaging (Mirror)

[6] Includes contrast (CnTI) in Adult Cardiac for left ventricle op

7T/3D/4D

26

S5MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

U.S. NUCLEAR REGULATORY COMMISSION
N.R.C. FORM 335 (7-77)
LICENSEE EVENT REPORT
CONTROL BLOCK
(PLEASE PRINT OR TYPE ALL REQUIRED INFORMATION)

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging (Mview)

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21 Santhoud Station Providers Provides Provincies Provincies P
PM Computer Times Mercer Program Provide op

713D/4D

27

ostic ultrasound imaging or fluid flow analysis of human body as Dis SB2C41
Intended use:

Previously cleared via K161

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

Breast includes

Atypical ductal hyperplasia
Ductal carcinoma in situ
Lobular carcinoma in situ
Invasive ductal carcinoma
Invasive lobular carcinoma
Paget's disease of the breast
Phyllodes tumor
Angiosarcoma

[2] Cardiac is Adult and Pediatric.

[3] Muscio Skeletal - Nerve Blood

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

[5] Compound Imaging (Mview)

Ni Nav Indication II Havolalar

1/3D/4D

28

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

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

Testicles and Prostate Cancer: What You Should Know

Organized by Testicular Cancer Awareness Foundation, Inc.

[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)

PCI includes contrast (Cr) - in Adult Cardiac [6].tiff

n: New Indexton, P. Previously closed in Prov. Bixded under Appendix e
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[]] Santhund mint metro many manufactures and manufactional
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7]/3D/4D

29

ST2612

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

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

Abstract. In this paper, we present a novel approach to the problem of semantic image segmentation. Our method is based on a deep convolutional neural network (CNN) that is trained to predict the semantic label of each pixel in an image. We show that our method achieves state-of-the-art results on several benchmark datasets. Furthermore, we demonstrate that our method is able to generalize well to new datasets and can be used to segment images of arbitrary size and resolution. Finally, we discuss the limitations of our method and suggest directions for future research.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Blood

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

[5] Compound Imaging. (NView)

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

1713D/4D

30

IOT342
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

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

14 Street Andrews Place, Stockwell, London SW9 0DE
Tel: 0207 733 3399. Fax: 0207 733 3399. International: +44 207 733 3399
Email: Orders@Hydroponics.co.uk. Internet: www.Hydroponics.org

[2] Cardiac is Adult and Pediatric.

[3] Musculo Skeletal - Nerve Blood

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

|5| Compound Imaging (MView)

N: New II dication Pri Freviously Christ S:Added under Appendix B
[2] Causeum Selection Created Cristies
[2] Canadao Secolor Artes Macros Croster Contribution Comments
[1] Co

[7] 3D/4D

31

510(k) Submission 6420 Upgrade Esaote S.p.A.

K183191

Special 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

Submitter Information

Esaote S.p.A.
Via Enrico Melen 77
16152 Genova
Italy
Phone: 039-055-4229402

| Contact Person: | Allison Scott, Associate Director
Navigant Consulting, Inc.
9100 Keystone Crossing, Suite 500
Indianapolis, IN 46240
317.228.8719 Office/317.228.8701 Fax
allison.scott@navigant.com |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 16, 2018 |
| 807.92(a)(2) | |

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	6420 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550
Ultrasound Pulse Echo Imaging System 892.1560
Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

32

807.92(a)(3)

Predicate Device(s)

Predicate	510(k)	Device	Owner
Primary	K161168	6420 — MyLabSix	Esaote Europe B.V.
Reference	K173291	6440 — MyLab 9 eXP	Esaote S.p.A.

Additional substantial equivalence information is provided in the substantial equivalence comparison table.

807.92(a)(4)

Device Description

The upgraded 6420 system (MyLabX5) is compact mainframe system equipped with wheels allowing to move the system. The system sizes and weights allow them to be carried using the handle.

The primary modes of operation are: 2D, M-Mode, Continuous Wave Doppler (CW), Tisue Enhancement Imaging (TEI), Multi View (MView), Doppler, Pulse Wave (PW) Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D.

6420 is equipped with a LCD color display where acquired images and advanced image features are shown. 6420 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). Model 6420 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry.

6420 is equipped with wireless capability.

Model 6420 was previously cleared via K161168.

The upgraded 6420 system, defined herein, combines the cleared features of both the 6440 and 6420 systems with new capabilities, listed below:

1. Management of Strain 2D.
1. Addition of Auto NT option.
1. Addition Auto EF option
1. Management of probe L 4-15.
1. Addition of Full screen option.
1. Operative system Windows 10

The 6420 new version is manufactured under an ISO 9001 and ISO 13485 certified quality system.

33

510(k) Submission 6420 Upgrade Esaote S.p.A.

807.92(a)(5)

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.

807.92(a)(6)

Technological Characteristics

The 6420 upgrade employs the same fundamental technological characteristics as their predicate devices.

The 6420 upgraded system is substantially equivalent to Esaote 6420 model cleared via K141486, and updated via K161168 clearance.

Clinical uses for which Esaote 6420 and 6440 models have been respectively cleared by FDA via K161168 and K173291 are not changed by the new 6420 version, to be cleared via this submission.
The management of Strain 2D on the upgraded 6420 system is identical to those of Esaote 6440 model, cleared via K173291.
Auto NT option on the upgraded 6420 system is identical to the one of Esaote 6440 model, cleared via K173291.
Auto EF (Ejection fraction) option on the upgraded 6420 system is identical to the one of Esaote 6440 model, cleared via K173291.
The probe L 4-15 management, added on the upgraded 6420 system has already cleared via K173291.
The upgraded 6420 system offer Full screen mode, identical to the one of Esaote 6440 model, cleared via K173291.
. The upgraded 6420 system works with Windows 10 Enterprise LTSB, operative system, exactly like Esaote 6440 model, cleared via K173291.

34

510(k) Submission 6420 Upgrade Esaote S.p.A.

807.92(b)(1)

Summary of Non-Clinical Tests

The upgraded 6420 system has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical Acoustic ● Output Indices on Diagnostic Ultrasound Equipment
NEMA UD-2 Acoustic Output Measurement Standard for Diagnostic Ultrasound ●

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The upgraded 6420 system is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Indications for Use

K183191

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

។ ។ ៣ ។ ហ ហ ក ល ១ ១ ១ ១ ជ ជ ព ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។ ។

SUPERIOR COURT OF CALIFORNIA, COUNTY OF LOS ANGELES

Pesticide Resistance

Pesticide Resistance Management Strategies

SE3133

TLC 3-13

IIH 6-18

SOS Children's Villages International

SL3235

SL3332

SC3421

AC2541

6. Circular permutation.

4/3D

AL2442

SL1543

S2MCW

ST2612

K183191

Special 510(k) Summary

Submitter Information

Predicate Device(s)

Device Description

Intended Use

Technological Characteristics

Summary of Non-Clinical Tests

Summary of Clinical Tests

Conclusion