MYLABFIVE
Device Facts
| Record ID | K083882 |
|---|---|
| Device Name | MYLABFIVE |
| Applicant | Esaote Europe B.V. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 30, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
Esaote's MyLabFive is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial). Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system 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.
Device Story
MyLabFive is a portable ultrasound system for diagnostic general imaging. Inputs: ultrasound signals from various phased, convex, linear, and Doppler probes. Processing: B-Mode, M-Mode, MView, Amplitude Doppler, Tissue Velocity Mapping (TVM), and Tissue Enhancement Imaging (TEI). Output: real-time ultrasound images on an integrated LCD display. Used in clinics or point-of-care settings by physicians or trained sonographers. Data stored on internal hard disk, external media, or via LAN/USB. Output used for clinical diagnosis, biopsy guidance, and needle/catheter placement. Benefits include portability for bedside use and diagnostic support across multiple anatomical structures.
Clinical Evidence
No clinical data. Substantial equivalence is based on bench testing, including comparison of acoustic output (Ispta, MI), measurement accuracy, and safety compliance with IEC60601-1 and IEC60601-2-37 standards.
Technological Characteristics
Portable ultrasound system with LCD display, alphanumeric keyboard, and internal hard disk. Supports phased, convex, linear, and Doppler probes. Connectivity via LAN/USB. Safety compliance: IEC60601-1, IEC60601-2-37. Software-driven imaging modes: B-Mode, M-Mode, MView, AD, TVM, TEI, CFM. Battery-powered operation supported.
Indications for Use
Indicated for diagnostic ultrasound imaging in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small organ, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Urologic examinations. Includes needle/catheter placement guidance and peripheral nerve blocks. No specific age or gender contraindications stated.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- MyLab40 (K070903)
- MyLab30 Gold Cardiovascular (K081794)
Related Devices
- K101605 — MYLABONE ULTRASOUND SYSTEM · Esaote Europe B.V. · Aug 31, 2010
- K071996 — MYLAB30, MODEL 7300 · Esaote, S.p.A. · Aug 3, 2007
- K052805 — MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 · Esaote, S.p.A. · Oct 17, 2005
- K051308 — MYLAB 70 ULTRASOUND IMAGING SYSTEM · Esaote, S.p.A. · Jun 1, 2005
- K053154 — MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM · Pie Medical · Dec 16, 2005
Submission Summary (Full Text)
{0}------------------------------------------------
510(k) Summary MyLabFive Esaote Europe
K0r3882
JAN 8 0 2009
# 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFRf807.92(a).
807.92(a)(1)
### Submitter Information
Jamie Austin Anson Group 11460 N. Meridian St., Ste. 150 Carmel, IN 46032 Phone: (317) 569-9500 x 118 Facsimile: (317) 569-9520
Contact Person: Jamie Austin
Date: December 10, 2008
807.92(a)(2)
Trade Name: MyLabFive Ultrasound System
Common Name: Ultrasound Imaging System
Classification Name(s):
| Ultrasonic pulse Doppler imaging system | 892.1550 |
|-----------------------------------------|----------|
| Ultrasonic pulsed echo imaging system | 892.1560 |
| Diagnostic ultrasonic transducer | 892.1570 |
Classification Number: 90IYN, 90IYO, 90ITX
-----
{1}------------------------------------------------
510(k) Summary MyLabFive Esaote Europe
| 807.92(a)(3) | | |
|---------------------|------------------------------------|---------------|
| Predicate Device(s) | | |
| K070903 | 2750 (MyLab40) | Esaote Europe |
| K081794 | 7340 (MyLab30 Gold Cardiovascular) | Esaote S.p.A. |
Additional substantial equivalence information is provided in the following substantial equivalence comparison table.
807.92 (a)(4)
### Device Description
The MyLabFive is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode. M-Mode, Multi View (MView), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). Optional is Doppler and Color Flow Mapping (CFM). The MyLabFive is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLabFive can drive phased (PA), convex (CA), linear array (LA) and Doppler probes.
The MyLabFive is equipped with an internal Hard Disk and with an optional external 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. Optional accessory devices available for the MyLabFive include an S-VHS video recorder, a monochrome or color page printer and a mobile trolley equipped with an insulation transformer.
#### 807.92(a)(5)
#### Intended Use(s)
Esaote's MyLabFive is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial). Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system 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.
{2}------------------------------------------------
510(k) Summary MyLabFive Esaote Europe
#### 807.92(a)(6)
Esaote believes that the MyLabFive is substantial equivalent to the Esaote MyLab30 Gold Cardiovascular product (K081794) and Esaote MyLab40 product (K070903).
- · The MyLabFive represents an evolution of the ESAOTE Europe MyLab40 system with regard to the technical capabilities: most of the hardware architecture is the same, the software driving the device is the same, the optional trolley providing an insulation transformer for safe peripherals connection are comparable to the trolley of the ESAOTE Europe MyLab40.
- · Clinical uses for which the MyLabFive is designed are identical to those cleared for the ESAOTE MyLab40 via K070903.
- · The MyLabFive Laparoscopic application makes use of the same design criteria of the ESAOTE 7340 (MyLab30 Gold Cardiovascular) cleared via K081794.
- The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the . ESAOTE Europe MyLab40 are designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
- · The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values
- · The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 provide a similar measurements and analysis package, with equal accuracy and precision.
- · The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 have digital storage capabilities, including Network connectivity.
- · Both the MyLabFive and the ESAOTE 7340 (MyLab30 Gold Cardiovascular) (K081794) are designed to be powered by battery when no main power is available.
- · The MyLabFive MView mode is available on other FDA cleared ultrasound systems, for instance the Esaote Europe MyLab40 cleared via K070903.
{3}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that appears to be an eagle or other bird-like figure.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ésaote Europe, B.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
JAN 30 2009
Re: K083882
Trade/Device Name: MyLabFive Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 14, 2009 Received: January 15, 2009
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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 i registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the MyLabFive, as described in your premarket notification:
Transducer Model Number
PA230 PA122 LA332 LA523P C5-2 R13 CA123 CA631 2 CW 5 CW
{4}------------------------------------------------
| EC1123 |
|--------|
| TRT33 |
| TEE022 |
| TEE122 |
| IOE323 |
| LP323 |
| I-5PA |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Vogue Mitha
A Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
## Indications for Use
510(k) Number (if known):
Device Name: MyLabFive
Esaote's MyLabFive is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
---
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
Prescription Use (Per 21 CFR 801.109)
{6}------------------------------------------------
#### MyLabFive
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------|-----|----------------------------------|-----------------|
| Ophthalmic | | | | | N | N | N | | N | 5, 6, 7 |
| Fetal | N | N | N | N | N | N | N | | N | 5, 6 |
| Abdominal | N | N | N | N | N | N | N | | N | 5, 6, 10 |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | | N | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | N | | N | 5, 6, 10 |
| Small Organ [1] | N | N | N | N | N | N | N | | N | 4, 5, 6, 10 |
| Neonatal Cephalic | N | N | N | N | N | N | N | | N | 5, 6 |
| Adult Cephalic | N | N | N | N | N | N | N | | N | 6 |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | 4, 6, 8, 9 |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | 4, 6, 8, 9 |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | N | | N | 5, 6, 10 |
| Transvaginal | N | N | N | N | N | N | N | | N | 5, 6 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | N | N | N | | N | 5, 6, 7, 9, 10 |
| Laparoscopic | N | N | N | N | N | N | N | | N | 5, 6, 10 |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | N | N | N | N | N | N | N | | N | 4, 5, 6, 10 |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | N | N | N | N | N | N | N | | N | 4, 5, 6, 10 |
| Other (Urological) | N | N | N | N | N | N | N | | N | 5, 6 |
(미 지 [기 (4) [5] ામ ছে ব্রিটিশন করে পারে।
প্রশ্ন থেকে বিশ্রাম বিশ্বের প্রায় প্রশ্ন করে বিশ্রাম বিশ্বের প্রায় প্রশ্ন করে প্রশ্ন করে প্রায় করে প্রশ্ন করে প্রযুক্তি করে পারে পারে পারে পারে পারে (9)
(10)
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CPM + PD СМЫ MVicw XView
QIMT Stress Strain TP View
**Prescription Use**
(Per 21 CFR 801.109)
Avram M. White
(Division Sign-Off) Division of Reproductive, Abdominat and Radiological Devices 510(k) Number _
{7}------------------------------------------------
| Clinical Application | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|-------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| | B | M | PWD | CWD | Color.<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | | P | 6 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | | P | 6 |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | 4, 6, 8, 9 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial (including<br>Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
#### PA230
The PA230 probe was previously cleared
via K070903 (1)
(2) (3) কি (리 ાંદો [7] (8) lal
(10)
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD смм MVicw XView QIMT gress 8train TP View
> Prescription Use (Per 21 CFR 801.109)
Vorzu hith
(Division Bign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
.
6
{8}------------------------------------------------
### PA122
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined [3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|--------------|-----|----------------------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | 6 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | | P | 6 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | P | P | P | P | P | P | 4, 6, 8, 9 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
cleared via K070903
[피
(기
(3)
(ન)
터
ទ្រ
[기
(8)
lal
l 10/
. '
.
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CW + CFM + PD СМЫ MVlew XVicw : QINT Stress Strain TP View
(Division Sign-Off)
Prescription Use . (Per 21 CFR 801.109)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083882
L
{9}------------------------------------------------
### LA332
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>(Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|-----|-----------------------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5, 6, 10 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 4, 5, 6, 10 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5, 6, 7, 9, 10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4, 5, 6, 10 |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4, 5, 6, 10 |
| Other (Urological) | | | | | | | | | | |
The LA332 probe was previously cleared via K081794
(1) (2)
(3) [4]
(5)
ાં રા
ரி
(8)
(의
|10|
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM MVicw XView QIMT 84ess Strain TP View
***(Division Sign-Off)***
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 83882
Prescription Use (Per 21 CFR 801.109)
.
L
{10}------------------------------------------------
### LA523P
| Clinical Application | Mode of Operations | | | | | | | | | | Other (specify) |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|----------------|-----------------|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5, 6, 10 | |
| Small Organ [1] | P | P | P | | P | P | P | | P | 4, 5, 6, 10 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5, 6, 7, 9, 10 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4,5,6,10 | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4, 5, 6, 10 | |
| Other (Urological) | | | | | | | | | | | |
| [1] | Small Organs includes Breast, Thyroid and Testicles |
|------|-----------------------------------------------------|
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | XView |
| [7] | QIMT |
| [8] | Stress |
| [9] | Strain |
| [10] | TP View |
Amym M. Wha
**Prescription Use**
(Per 21 CFR 801.109)
L
・
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ 887
MyLabFive 510(k) December 2008
.
·
{11}------------------------------------------------
| Clinical Application | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | 5, 6, 7 |
| Abdominal | P | P | P | | P | P | P | | P | 5, 6 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5,6 |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 5, 6 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac (2) | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5, 6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
The CS-2 probe was ps evious
(1) (기 (ગ ામ ([[[] (6) [기 ાં જો ાં છે. 110)
.
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM MView . XView ਼ੀਆ
Streess
Strain
TP Vlew
Aoyu In Whang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083882 510(k) Number
**Prescription Use**
(Per 21 CFR 801.109)
{12}------------------------------------------------
### CA123
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5, 6 |
| Small Organ [1] | P | P | P | | P | P | P | | P | 4,5,6 |
| Neonatal Cephalic | P | P | P | | P | P | P | | P | 5, 6 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | P | P | P | | P | P | P | | P | 4, 5, 6 |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | 5,6, 9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4, 5, 6 |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4, 5, 6 |
| Other (Urological) | | | | | | | | | | |
The CA123 probe was
[1] 기 (3) ામ ાંગ િશ [기 (8) la) | 10|
XView
QIMT
Stress
Strain
TP View
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CW + CPM + PD смм MVicw
(a
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 085882 510(k) Number
Prescription Use (Per 21 CFR 801.109)
{13}------------------------------------------------
| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | 5,6,7 |
| Abdominal | P | P | P | | P | P | P | | P | 5,6 |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | 5,6 |
| Small Organ [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 | 5,6,9 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4,5,6 |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | P | P | P | | P | P | P | | P | 4,5,6 |
| Other (Urological) | P | P | P | | P | P | P | | P | 5,6 |
The CA631 probe was
cleared via K070903 previously
- [1] . (기 [3] િની (왕) ાંઠા (ग ામાં lal ( ol
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM NVicw
XView
QIMT
8tress
Strain
TP Vlew
Tony M. White
---
(Division Sign Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
### CA631
:
. .
{14}------------------------------------------------
| 2 CW |
|------|
| 0.00 |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined [3] | TVM | Tissue Enhancement Imaging (TEI) | Other (specify) |
|-------------------------------------------------------------|---|---|-----|-----|---------------|-------------------|--------------|-----|----------------------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | P | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | |
The 2Cw probe was p GAIDULTI
| [1] | Small Organs includ |
|------|----------------------|
| [2] | Cardiac is Adult and |
| [3] | Combined modes an |
| [4] | CMM |
| [5] | MView |
| [6] | XView |
| [7] | QIMT |
| [8] | Stress |
| [9] | Strain |
| [10] | TP View |
des Breast, Thyroid and Testicles d Pediatric re: B + M + PW + CW + CW + CPM + PD
Division Sign Org
(Division Sign-Off) V Division of Reproductive, Abdominal and Radiological Devices 083882 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
.
e.
{15}------------------------------------------------
| | Mode of Operations | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|---------------------|----------------------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>TVM (3) | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (1) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac [2] | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | | | P | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | |
| Other (Urological) | | | | | | | | | |
The SCW probe was previously
| cleared via K070903 | |
|---------------------|-----------------------------------------------------|
| [1] | Small Organs includes Breast, Thyroid and Testicles |
| [2] | Cardiac is Adult and Pediatric |
| [3] | Combined modes are: B + M + PW + CW + CFM + PD |
| [4] | CMM |
| [5] | MView |
| [6] | XView |
| [7] | QIMT |
| [8] | Stress |
| [9] | Strain |
| [10] | TP View |
Sonny Weaver
Prescription Use (Per 21 CFR 801.109)
1
(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K083882
.
{16}------------------------------------------------
#### EC1123
| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | 5,6,7 |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | 5,6 |
| Transvaginal | P | P | P | | P | P | P | | P | 5,6 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | P | P | P | | P | P | P | | P | 5,6 |
cleared via K081794
. (1) (2) [3] [ፈር (ട) (6)
। ਸ
(8)
ીકો
[10]
.
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric
Combined modes are: B + M + PW + CW + CFM + PD
CMM MView XVicw QIMT இருக்க Strain
TP View
Arra In Wha
Prescription Use (Per 21 CFR 801.109)
> . .
.
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 082882 510(k) Number
{17}------------------------------------------------
### TRT33
| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|-----------------|
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>[3] | TVM | Tissue<br>Enhancement<br>Imaging (TEI) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | | P | 5,6,10 |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional<br>(including Nerve Blocking) | | | | | | | | | | |
| Musculo-skeletal Superficial<br>(including Nerve Blocking) | | | | | | | | | | |
| Other (Urological) | P | P | P | P | P | P | P | | P | 5, 6, 10 |
The TRT33 probe was previously
cleared via K081794 [1]
(2)
િંગ્લ ાં ના
ાજી
ાંધા
11
ម្រៀ
(9)
(10)
.
Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD CMM MVlew XVicw QIMT Stress Strain TP View
Lorri M. Wertz
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083882 510(k) Number
{18}------------------------------------------------
#### TEE022
| | Mode of Operations | | | | | | | | | |
|-------------------------------------------------------------|--------------------|---|-----|-----|------------------|----------------------|-----------------|-----|----------------------------------------|…
