LogoFDA 510(k) Search
K Number
K161168
Device Name
MyLabSix Ultrasound System
Manufacturer
Esaote Europe B.V.
Date Cleared
2016-09-02

(129 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
Device Description
The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D. The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. The MyLabSix is also equipped with a height adjustable/rotating keyboard. A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel. The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes. The MyLabSix is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port. The MyLabSix is already cleared via K141486. The MyLabSix Upgrade, defined herein, combine the cleared features of MyLabSix system with new software capabilities, listed below: 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urologic and Transvaginal applications 2. Management of Laparoscopic application 3. Implementation of the Needle Visibility feature 4. Implementation of the on-board tutorial MyLibrary feature. The MyLabSix Upgrade is manufactured under an ISO 9001 and ISO 13485 certified quality system.
More Information

K141486

K142008, K101605, K113156

No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The described features are standard ultrasound functionalities and software upgrades.

No
The device is used for diagnostic imaging, guidance for biopsy, and assisting in needle placement, which are all diagnostic or procedural guidance functions, not therapeutic ones.

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

No

The device is described as a "mainframe ultrasound system" with physical components like a display, keyboard, probes, and storage drives. While it includes software upgrades, it is fundamentally a hardware system with integrated software.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Function: The MyLabSix ultrasound system is an imaging device that uses sound waves to create images of internal body structures. It does not analyze biological specimens.
  • Intended Use: The intended uses listed are all related to performing diagnostic imaging studies and guiding procedures based on those images. None of the uses involve the analysis of in vitro samples.

Therefore, the MyLabSix ultrasound system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

N/A

Intended Use / Indications for Use

Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D.

The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. The MyLabSix is also equipped with a height adjustable/rotating keyboard.

A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.

The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.

The MyLabSix is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The MyLabSix is already cleared via K141486.

The MyLabSix Upgrade, defined herein, combine the cleared features of MyLabSix system with new software capabilities, listed below:

    1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urologic and Transvaginal applications
  • Management of Laparoscopic application 2.
  • Implementation of the Needle Visibility feature 3.
  • Implementation of the on-board tutorial MyLibrary feature 4.

The MyLabSix Upgrade is manufactured under an ISO 9001 and ISO 13485 certified quality system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler imaging
Ultrasonic pulsed echo imaging

Anatomical Site

Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic, Urologic.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

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)

K141486

Reference Device(s)

K142008, K101605, K113156

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 2, 2016

Esaote Europe B.V. % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K161168

Trade/Device Name: MyLabSix Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 1, 2016 Received: August 2, 2016

Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert 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)

K161168

Device Name

MyLabSix Ultrasound System

Indications for Use (Describe)

Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPPP: 5 N/A
FetalPPPPPPPPPP: 5 N/A
AbdominalPPPPPPPPPP: 5 N/A
Intraoperative (Abdominal)PPPPPPPPPP: 5 N/A
Intraoperative NeurologicalPPPPPPPPPP: 5 N/A
PediatricPPPPPPPPPP: 5 N/A
Small Organs [1]PPPPPPPPPP: 5 N/A
Neonatal CephalicPPPPPPPPPP: 5 N/A
Adult CephalicPPPPPPPPPP: 5 N/A
Cardiac [2]PPPPPPPPPP: 5 N/A
Transesophageal (Cardiac)PPPPPPPPPP: 5 N/A
Transesophageal (Non Cardiac)PPPPPPPPPP: 5 N/A
TransrectalPPPPPPPPPP: 5 N/A
TransvaginalPPPPPPPPPP: 5 N/A
TransurethralPPPPPPPPPN: 5 N/A
IntravascularPPPPPPPPPP: 5 N/A
Peripheral VascularPPPPPPPPPP: 5 N/A
LaparoscopicNNNNNNNNNN: 5 N/A
Musculo-skeletal Conventional [3]PPPPPPPPPP: 5 N/A
Musculo-skeletal Superficial [3]PPPPPPPPPP: 5 N/A
Other (Urological)PPPPPPPPPP: 5 N/A
5420 is already cleared via K141486 and to be cleared with this submission

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Visualization of the left ventricular endocardial border using cardiac magnetic resonance imaging

F1/3D/4D

4

SI2C41SL3116SE3133TLC 3-13IH 6-18IL 4-13LP 4-13SB3123SL3323SL3235SL2325SL3332SC3421AC2541SC3123SE3123AL2442SL1543SP2730S2MCWS5MCWSB2C41SHFCWST2612IOT342
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5

Prescription Use Only Per 21 CFR 801 Part D Concurrence of

DRH, Office of In Vitro Diagnostics and Radiological Health (OlR

| Clinical Application | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler
(AD) | Combined
[4] | Color Velocity
Mapping (TVM) | Harmonic
Imaging (TEI) | Other (specify) |
|----------------------------------|---|---|-----|-----|------------------|------------------------------|-----------------|---------------------------------|---------------------------|-----------------|
| Ophthalmic | E | E | E | E | E | E | E | E | E | E: 5 |
| Fetal | E | E | E | E | E | E | E | E | E | E: 5 |
| Abdominal | E | E | E | E | E | E | E | E | E | E: 5 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | E: 5 |
| Small Organs [1] | E | E | E | E | E | E | E | E | E | E: 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | E | E | E | E | E | E | E | E | E | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | E | E | E | E | E | E | E | E | E | E: 5 |
| Musculo-skeletal Superficial [3] | E | E | E | E | E | E | E | E | E | E: 5 |
| Other (Urological) | E | E | E | E | E | E | E | E | E | E: 5 |
| The SI2C41 probe is added | | | | | | | | | | |
| 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) | P | P | P | | P | P | P | | P | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | E: 5 |
| Small Organs [1] | P | P | P | | P | P | P | | P | E: 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 | E: 5 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | E: 5 |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | E: 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 | | E | | | E | | E | | E | E: 5 |
| Fetal | E | E | E | | E | E | E | | E | E: 5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | | E | E: 5 |
| Transvaginal | E | E | E | | E | E | E | | E | E: 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 |
| *the SE3133 probe is added | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
| Ophthalmic | E | E | E | | E | E | E | | | |
| Fetal | | | | | | | | | | E: 5 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | E | E | E | | E | E | E | | E | E: 5 |
| Transvaginal | E | E | E | | E | E | E | | E | E: 5 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | |
| Other (Urological) | E | E | E | | E | E | E | | E | E: 5 |
| he TLC 3-13 probe is added und | | | | | | | | | | |

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

The S12C41 probe is added under Appendix F and to be

under Appendix E and to be

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

Testicles and Prostate
Breast Studies
Thyroid Studies
Brain Scans

SOME STRAINS include Brazil, Reunion and India.

OIL contains both and Palmitic

[3] Musculo Skeletal - Nerve Block
[4] Cardiac is Auricular and Pendular

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

[5] Compound Imaging (M-view)

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6

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

The SESTTO probe is all cady
cleared via K101605 and added
under Appendix E

under Appendix E

under Appenda B

(1) Small Organs includes Breast, Thyroid etc.

(2) Cardiac is Adult and Pediatric

[32] Musculo Skeletal - Nerve Block

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

1.5 Compound Imaging (M-View)

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

INSPECTION OF LINE FOR VERTICAL BORD
AND HORIZONTAL BORD

REHABILITATION OF MYOCARDIAL INFARCTION PATIENTS

7

Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo SE3133

under Appendix E and to be
cleared via this submission

N: New indication: P: Previously cleared by FDA: E:Added und

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  1. Cardiac is Adult, Pediatric and Pediatric Cardiac

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﻌﺪﺩﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ

[7]3D/4D

8

T L C 3-13
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

The TLC 3-13 probe is added under
Appendix E and to be cleared via this submission

SUBMISSIONS

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17

  1. Small Organs includes Breast, Thyroid

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M, PW+M, C+V

REC COMBINED INDEX (RCI) + TOTAL HIRS RAD

imaging (mview)
[6] Includes contrast (CTI) in Adult Cardiac fo

INCREASED CONTRAST FORM IN FINAL SURFACE FOR ISOLATION of the left ventricular endocardial border [5.1A]

DIVISION OF REAL ESTATE, PENNSYLVANIA DEPARTMENT
OF STATE

APPLICATION FOR REAL ESTATE SALESPERSON LICENSE

9

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

Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicEEEEEEEE: 5
FetalEEEEEEEE: 5
AbdominalEEEEEEEE: 5
Intraoperative (Abdominal)EEEEEEEE: 5
Intraoperative Neurological
PediatricEEEEEEEE: 5
Small Organs [1]EEEEEEEE: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE: 5
Laparoscopic
Musculo-skeletal ConventionalEEEEEEEE: 5
Musculo-skeletal Superficial [3]EEEEEEEE: 5
Other (Urological)EEEEEEEE: 5
The IH 6-18 probe is added
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
OphthalmicEEEEEEEEEE: 5
FetalEEEEEEEEEE: 5
AbdominalEEEEEEEEEE: 5
Intraoperative (Abdominal)EEEEEEEEEE: 5
Intraoperative Neurological
PediatricEEEEEEEEEE: 5
Small Organs [1]EEEEEEEEEE: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEEEE: 5
Laparoscopic
Musculo-skeletal Conventional [3]EEEEEEEEEE: 5
Musculo-skeletal Superficial [3]EEEEEEEEEE: 5
Other (Urological)

the IH 6-16 probe is added under Appendix E and to be

moner of 10 probe is and to be
under Appendix E and to be
cleared via this submission

अध्यक्ष र काम बनाने बाली बात
2018 - 12:44 PM Previous Provinsia Provinsia P
11 News March March Proved by Provinsia Provinsia B
13 News Market Marian Prove Corporation a

  1. Small Organs includes Breast, Thyroid and more!

[2] Cardiac is Adult and Pediatric

  1. Musculo Skeletal - Nerve Block

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

[S]-Compound Imaging Signal (MEAN) (Arbitrary)

CALCULATES COMPRESSOR VENT FACTOR FOR VENT LINE

Cardiovascular, Endocrine, Neurologic, Musculoskeletal, Pulmonary, Renal, Gastrointestinal, Hematologic, Immunologic, Dermatologic, Ocular, ENT, Dental, and Mental Disorders

border radial
and occular
centric
left of the
adaptation
realizes

10

Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)

under Appendix E and to be cleared via this submission

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

  • Breast
  • Cancer
  • Articles
  • Including
  • Ocean
  • Small
  1. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Nview)

classed via antilation
11 Marcin Results Marceller
11 Marcula elemin Merceller
13 Marcula elemin Merce Marcel Marie Marie Maria Maria Marina and
13 Marcula Republican Particl

F1/3D/4D

11

_P 4-13
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as for

Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalNNNNNNNN: 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
LaparoscopicNNNNNNNN: 5
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
SB3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicNNNNNNNN: 5, 7
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalNNNNNNNN: 5, 7
TransvaginalNNNNNNNN: 5, 7
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)NNNNNNNN: 5, 7
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPPP: 5
Intraoperative (Abdominal)PPPPPPPPP: 5
Intraoperative Neurological
PediatricPPPPPPPPP: 5
Small Organs [1]PPPPPPP: 5
Neonatal CephalicPPPPPPP: 5
Adult Cephalic
Cardiac [2]PPPPPPPPP: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)
the SL3323 probe is already
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5
Small Organs [1]PPPPPPPP: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)
Intended use: Diagnostic ultrasound Imaging or fluid flow analysis of human body as follows:Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricEEEEEEEE: 5
Small Organs [1]EEEEEEEE: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularEEEEEEEE: 5
Laparoscopic
Musculo-skeletal ConventionalEEEEEEEE: 5
Musculo-skeletal Superficial [3]EEEEEEEE: 5
Other (Urological)
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPP
FetalPPPPPPPP: 5
AbdominalPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5
Small Organs [1]PPPPPPPP: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPPP: 5
Other (Urological)
The SL3332 probe is already
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPPP: 5
FetalPPPPPPPPPP: 5
AbdominalPPPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPPP: 5
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPPPP: 5
Other (Urological)PPPPPPPPPP: 5
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPP
FetalPPPPPPPP: 5
AbdominalPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
IntravascularPPPPPPP
Peripheral VascularPPPPPPPP: 5
LaparoscopicPPPPPPP
Musculo-skeletal ConventionalPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)PPPPPPPP: 5
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPP
FetalPPPPPPPP: 5
AbdominalPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5
Small Organs [1]PPPPPPP: 5
Neonatal CephalicPPPPPPP: 5
Adult Cephalic
Cardiac [2]PPPPPPPP: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal Conventional [-]PPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP: 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
TransrectalPPPPPPP: 5
TransvaginalPPPPPPP: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)PPPPPPP: 5
The SE3123 probe is already
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPPPPP: 5
FetalPPPPPPPPPP: 5
AbdominalPPPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPPPP: 5
Small Organs [1]PPPPPPP: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPPPPP: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPPPPP: 5
Other (Urological)
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
OphthalmicPPPPPPP: 5
FetalPPPPPPP: 5
AbdominalPPPPPPPP: 5
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP: 5
Small Organs [1]PPPPPPPP: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]PPPPPPPP: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal Conventional [-]PPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)
Mode of Operations
Clinical ApplicationBMPWDCWDColor DopplerAmplitude Doppler (AD)Combined [4]Color Velocity Mapping (TVM)Harmonic Imaging (TEI)Other (specify)
Ophthalmic
FetalPPPPPPPP
AbdominalPPPPPPPP
Intraoperative (Abdominal)
Intraoperative Neurological
PediatricPPPPPPPP
Small Organs [1]
Neonatal CephalicPPPPPPPP
Adult CephalicPPPPPPPP
Cardiac [2]PPPPPPPPP
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP
Laparoscopic
Musculo-skeletal ConventionalPPPPPP
Musculo-skeletal Superficial [3]
Other (Urological)
The SP2730 probe is already
Clinical ApplicationMode of Operations
BMPWDCWDColor
DopplerAmplitude
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]P
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularP
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical ApplicationMode of Operations
BMPWDCWDColor DopplerAmplitude 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 VascularP
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
the S5MCW probe is already
Clinical ApplicationMode of OperationsColor Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
BMPWDCWDColor
DopplerAmplitude
Doppler (AD)Combined [4]
Ophthalmic
FetalPPPPPPPP: 5, 7
AbdominalPPPPPPPP: 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)
*the SB2C41 probe is already
Clinical ApplicationBMPWDCWDColor DopplerAmplitude 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
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
the SHFCW probe is already
Clinical ApplicationBMPWDCWDColor DopplerAmplitude 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)PPPPPPPPPP: 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
the ST2612 probe is already
Clinical ApplicationBMPWDCWDColor
DopplerAmplitude
Doppler
(AD)Combined
[4]Color Velocity
Mapping (TVM)Harmonic
Imaging (TEI)Other (specify)
Ophthalmic
Fetal
AbdominalPPPPPPPP: 5
Intraoperative (Abdominal)PPPPPPPP: 5
Intraoperative Neurological
PediatricPPPPPPPP: 5
Small Organs [1]PPPPPPPP: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral VascularPPPPPPPP: 5
Laparoscopic
Musculo-skeletal ConventionalPPPPPPPP: 5
Musculo-skeletal Superficial [3]PPPPPPPP: 5
Other (Urological)
The IOT342 probe is already

the LP-4-13 probe is to

eared via this submission

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

[J Small Organs Includes Breast, Thyroid and Testicles

  1. Cardiac is Adult and Pediatric

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

PER COMBINAZIONI DI CUI
AL PUNTO 1.1.1. (modello
approvato) - Allegato I
EC-Type Examination Certificate

(6) Includes contrast (Ch. M.) in Adult Cardiac for [1].

Ni New Mindenen Pirev Basic Articles Microsoft Microsoft P
Ri Musicula Status Arteres Brander Marcel Marcel Marcular B
Ri Museum electures Marce Electric Reserver Leider an

7[3D/4D

12

The SB3123 probe is to be

cleared VIS this submission

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

Organisms in Small Niches

Species that have narrow niches are called specialist species [1].

Specialist species are very good at surviving in a particular environment. However, they are not able to adapt well to new conditions. For example, the koala is a specialist species that eats only eucalyptus leaves. If eucalyptus trees become scarce, the koala population will decline.

Species that have broad niches are called generalist species [1].

Generalist species are able to survive in a wide range of environmental conditions. For example, raccoons are generalist species that eat a variety of foods and live in a variety of habitats. Raccoons are able to adapt well to new conditions, so their populations are often stable or increasing.

[2] Cardiac is Adult and Pediatric

  1. Musculo Skeletal - Nerve Block
    (Parane to Heart and Femoral)

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

[5] Compound Imaging (Mview)

ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺮﺟﻢ ﺍﻟﻤﺮﺍﺟﻊ

ZL23D/4D
FORMATION OF THE RETICULAR

13

SL3323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

the SL323 probe is alr

cleared via K141486

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

SCHOLARS' ROUNDTABLE SERIES

Breast Cancer: Prevention and Treatment Strategies

Organised by: Small Enterprise Association of Australia [1]

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[15]. Compound Imaging. (MVview, Matrox Imaging, Dorval, Canada).

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

.1/3D/4D

14

SL3235
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

The SL3325 probe is al

the SB325 Spring Stared via K141486

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

Small Molecules
Organic Chemistry I
CHEM 2324: Nomenclature and Reactions
Dr. Michael P. Eastman

[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)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

7T/3D/4D

15

Prescription Use Only Per 21 CFR 801 Part D Concurrence
DRH, Office of In Vitro Diagnostics and Radiological Health (

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

under Appendix E and to b

A. INTRODUCTION
B. DEFINITIONS
C. MINIMUM REQUIREMENTS
D. DATA REQUIREMENTS
E. FDA REVIEW
F. CLEARANCE
G. POSTCLEARANCE REQUIREMENTS
H. REFERENCES

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

1

01

1

1

L1 Small Organs Includes Breast, Thyroid, Adrenals, Pituitary, and Pineal

[2] Surface is rough and irregular
[3] Musculo skeletal - Nerve Blood

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

[5] Compound Imaging (Mview)

N: New Indestion, Previously Provinsia Previous B
[]] Garallo II Shadesh Twitters Press.
[]] Ramules Mark British Previous Provinsia
[]] Remained minter (2008) Provedend Prod

[7] 3D/4D

16

SL3332
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

the SB3332 production of the Stared via K141486

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

Organics and
Testing Services
101 S. Main St. • PO Box 549 • Lake Benton, MN 56149
www.organicsandtesting.com

[2] Cardiac : Adult and Pediatric

[13 Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (Mview)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

V13D/4D

17

the SC3421 probe is alr

the SCS-12 Kp. 12 Kp. 12 K

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

ORGANIC BREADS
Includes: Sourdough, Multigrain, Rye, and Rustic Italian

[2] Cardiac Adult and Pediatric

  1. Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

1713D/4D

18

\C2541
tended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

The AC2541 probe is at

  1. 111495

cleared via K141486

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

Standard Operating Procedures and Testing Protocols

  1. Sample Collection & Handling
  2. Breast Milk Analysis

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[15] Compound Imaging (Mview)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

713D/4D

19

SC3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

the SC3123 probe is alt

the SCorizo pria K141486

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

SCHEMATIC REPRESENTATION OF THE THYROID GLAND AND ITS PERIFOLICULAR STRUCTURES, INCLUDING THE PARATHYROID GLANDS

12: Cardiacs: Adult and Pediatric

[13 Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺮﺟﻢ ﺍﻟﻤﺮﺍﺟﻊ

713D/4D

20

SE3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

the SE3T23 probe is cleared via K141486

cleared via K14186

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

Organisms in Small Niches

  1. Generalists: Species that can survive in a wide array of environmental conditions and utilize a variety of resources (e.g., raccoon).
  2. Specialists: Species that thrive in a narrow range of environmental conditions or have a limited diet (e.g., panda).
  3. Niche Breadth: The range of resources or conditions within which a species can survive and reproduce.
  4. Niche Partitioning: The process by which natural selection drives competing species into different patterns of resource use or different niches. Niche partitioning allows several species to coexist in the same area because they avoid direct competition.
  5. Fundamental Niche: The full potential range of physical, chemical, and biological factors a species can use if there is no competition from other species.
  6. Realized Niche: The actual niche a species occupies, which is narrower than its fundamental niche due to competition and other factors.

[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)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

713D/4D

21

AL2442

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

the AL2442 probe is al

the AB2 via K141486

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

Some SCHEMERS and others: including: BREAST, Thyroid, Prostate, Testicles and Ovaries. [1] Small Organelles

[2] Cardiac - Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (MView)

ﺍﻟﻤﺎﺿﻴﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺮﺟﻢ ﺍﻟﻤﺮﺍﺟﻊ

71/3D/4D

22

SL 1543
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human Made of S

The SL1543 probe is alr

cleared via K141486

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

Small, Thyroid, Breast, and Testicular Cancers
Organized by RSNA Body Part Task Forces

[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)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

7/3D/4D

23

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

cleared via K141486

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

U.S. EPA'S INTEGRATED RISK INFORMATION SYSTEM (IRIS) DATABASE: HUMAN HEALTH EFFECTS FROM EXPOSURE TO BROMOFORM, NITRATE AND NITRITE, AND PESTICIDES

  1. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

5.5 Combined modes are, B, M, N, CN
5.5 Compound Imaging: Nirvana

ﺍﻟﻤﺎﺿﺔ ﺍﻟﻤﺎﺿﻴﺎﺕ ﺍﻟﻤﺘﺤﻘﺔ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺎﺭﺱ ﺍﻟﻤﺎﺿﻲ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤ
ﺍﻟﻤﺎﺿﻴﺎﻧﻴﺔ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺮﺍﺟﻊ

visualization of the left ventricular end

[7] 3D/4D

24

S2MCW

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

The S2MCW probe is alread
cleared via K141486

cleared via KI14186

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

Small Oysters increase Breast, Thyroid and Testicle

  1. Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-view)

ander in Previously classe of PDA; Endded under Appendix ander Appendix a
[3] Museum a Reviews - Revel Printer
[3] Museum a Reserver - Wercement
[3] Compound Image are: BMP W

escription Use Only Per 21 CFR 801 Part D Concurrence

25

S5MCW

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

The SSM/CW probe is al

cleared via K141486

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

Small Organic Molecules (SOMs) BREAST, THYROID and PANCREAS Testing and Research Studies

[2] Cardiac Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[FC Compound Imaging (N.view)]

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

713D/4D

26

SB2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

The SBC24.1 probe is at

cleared via K141486

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

SCHEMATIC SECTION

A. POWER DISTRIBUTION

B. INPUT & OUTPUT SECTION

C. PROCESSOR & MEMORY SECTION

[2] Cardiac is Adult and Pediatric

  1. Musculo skeletal - Nerve Block

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

[5] Compound Imaging (Mrview)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

71/3D/4D

27

SHFCW

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

the SHFCW probe is ali

C rile bir career production of the cleared via K141486

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

ORGANIC SMALL MOLECULES - R. HYPERVALENT IODINE AND PEROXIDES

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[15] Compound Imaging (MView)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺎﺑﻌﺔ ﻣﻮﺍﻗﻌﺔ ﺍﻟﻤﻌﺎﻣﺔ

7T3D/4D

28

ST2612
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human and and

The ST5612 probe is al

cleared via K141486

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

Small-cell Lung Cancer (SCLC) is an aggressive neuroendocrine tumor that is strongly associated with smoking. SCLC is characterized by rapid growth, early metastasis, and sensitivity to chemotherapy and radiation. Despite initial responses to treatment, most patients with SCLC relapse and develop resistance to therapy. The prognosis for SCLC remains poor, with a 5-year survival rate of only about 5-10%. Recent advances in immunotherapy have shown promise in improving outcomes for some patients with SCLC, but more research is needed to develop effective therapies for this challenging disease.

[1] Byers LA, Rudin CM. Small cell lung cancer: update on diagnosis, treatment, and new strategies. Lancet. 2017 May 6;389(10074):1559-1569.

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

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

[5] Compound Imaging (M-View)

ﺍﻟﻤﺎ ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

713D/4D

29

OT 342
ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follo

cleared via K141486

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

BREAST CANCER RISK ASSESSMENT
FOR WOMEN WITH A FAMILY HISTORY
OF BREAST CANCER

Name:
Date of Birth:
Age:
Race/Ethnicity:

[2] Cardiac: Adult and Pediatric

[3] Musculo skeletal - Nerve Block

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

LSC Compound Imaging (MNView)

11 New II diestion i Pi Reviews cleared by PDA BiAded under Appendix E
13 Marcula Selection Arterialses
13 Marcula Selection - Nerolama
13 Museum Selection - News CW-CW-CW-

[7] 3D/4D

30

510(k) Summary MyLabSix Esaote Europe

510(k) Summary

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

807.92(a)(1)

Submitter Information

Esaote Europe B.V. Philipsweg 1 6227 AJ Maastricht The Netherlands

| Contact Person: | Allison Scott, Managing Consultant
317.228.8719 Office
317.372.0276 Mobile
317.228.8701 Fax
allison.scott@navigant.com |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 17, 2016 |
| 807.92(a)(2) | |
| Trade Name: | MyLabSix Ultrasound System |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse Doppler imaging system
Ultrasonic pulsed echo imaging system
Diagnostic ultrasonic transducer |
| Classification Number: | 90IYN, 90IYO, 90ITX |

892.1550 892.1560 892.1570

31

807.92(a)(3)

Predicate510(k)DeviceOwner
PrimaryK1414866420 - MyLabSixEsaote Europe B.V.
ReferenceK1420086400 - MyLabSevenEsaote S.p.A.
ReferenceK1016058100 - MyLabOneEsaote Europe B.V.
ReferenceK113156SonoSite EdgeFujifilm SonoSite, Inc.

Predicate Device(s)

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

Device Description

The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, 3D and 4D.

The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown. The MyLabSix is also equipped with a height adjustable/rotating keyboard.

A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.

The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.

The MyLabSix is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

The MyLabSix is already cleared via K141486.

The MyLabSix Upgrade, defined herein, combine the cleared features of MyLabSix system with new software capabilities, listed below:

    1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urologic and Transvaginal applications
  • Management of Laparoscopic application 2.
  • Implementation of the Needle Visibility feature 3.
  • Implementation of the on-board tutorial MyLibrary feature 4.

The MyLabSix Upgrade is manufactured under an ISO 9001 and ISO 13485 certified quality system.

32

807.92(a)(5)

Intended Use(s)

Esaote's MyLabSix ultrasound system is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

807.92(a)(6)

Technological Characteristics

Esaote Europe's MyLabSix Upgrade employs the same fundamental technological characteristics as its predicate devices. The MyLabSix Upgrade is substantially equivalent to Esaote Europe's MyLabSix already cleared via K141486, Esaote's MyLabSeven already cleared via K111302, K132231, K132466 and K142008, Esaote Europe's MyLabOne already cleared via K101605 and to SonoSite Edge already cleared via K113156.

  • · Clinical uses for which the MyLabSix, cleared via K141486, is designed are not changed by the MyLabSix Upgrade, to be cleared via this submission.
  • · Clinical uses for which the MyLabSix Upgrade is designed are equivalent to those of MyLabSeven, already cleared via K142008.
  • · The MyLabSix Upgrade for managing Laparoscopic application is equivalent to those of MyLabSeven already cleared via K142008.
  • · The MyLabSix Upgrade for managing of motorized probes (Bi-Scan probes) that allow volumetric acquisition in 3D/4D mode for Transrectal/Urology and Transvaginal applications is equivalent to those of MyLabSeven, already cleared via K142008.
  • · The MyLabSix Upgrade including the Needle Visibility feature is equivalent to those of SonoSite Edge, already cleared via K113156.

33

  • · The MyLabSix Upgrade including the on-board tutorial MyLibrary feature, that provide application aid and tips in the use of the system during procedures is equivalent to those of MyLabOne, already cleared via K101605.
  • . The MyLabSix Upgrade, MyLabSix, MyLabSeven, MyLabOne and SonoSite Edge are designed to meet the IEC60601-1 and the IEC60601-2-37 safety requirements.
  • The MyLabSix Upgrade, MyLabSix, MyLabSeven, MyLabOne and SonoSite Edge provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
  • The MyLabSix Upgrade, MyLabSix, MyLabSeven, MyLabOne and SonoSite Edge provide a similar measurements and analysis package, with equal accuracy and precision.
  • . The MyLabSix Upgrade, MyLabSix, MyLabSeven and MyLabOne have digital storage capabilities, including Network connectivity.
  • The MyLabSix Upgrade image modes are available on other FDA cleared ultrasound . systems, for instance MyLabSeven.

807.92(b)(1)

Summary of Non-Clinical Tests

The MyLabSix Upgrade has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and have been found to conform to the following medical device safety standards:

  • · IEC 60601-1 Ed. 3.0 (2005-12) · Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Corrigendum 1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Corrigendum 2:2007 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
  • IEC 60601-1-2 Ed. 3.0 (2007-03) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and Tests.
  • · IEC 60601-2-37 Ed. 2.0 (2007-08) Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
  • ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

34

  • · NEMA Standards Publication UD 2-2004 Revision 3 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
  • · NEMA Standards Publication UD 3-2004 Revision 2 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

807.92(b)(2)

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusion

The MyLabSix Upgrade is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.