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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Esaote MyLabFive Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices (Esaote MyLab40 and MyLab30 Gold Cardiovascular) rather than presenting a standalone study with acceptance criteria and performance data for the MyLabFive itself.

Therefore, the requested information cannot be fully extracted as there isn't a dedicated "study that proves the device meets the acceptance criteria" in the format typically used for performance validation of new algorithms or diagnostic tests. Instead, the document asserts equivalence based on shared technical capabilities, software, safety standards, acoustic output, and measurement accuracy with previously cleared devices.

However, I can extract information related to the claimed performance and what would typically constitute acceptance criteria in such a submission:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" or "reported device performance" in terms of specific metrics like sensitivity, specificity, accuracy, or quantitative measurements that would be expected for a new diagnostic algorithm. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the MyLabFive performs as well as or is equivalent to the predicate devices for its intended uses and various operational modes.

The stated performance claim is:

"The MyLabFive, ESAOTE 7340 (MyLab30 Gold Cardiovascular) and the ESAOTE Europe MyLab40 provide a similar measurements and analysis package, with equal accuracy and precision."

This statement implies that the accuracy and precision of the MyLabFive are considered acceptable if they are equal to those of the predicate devices. However, no specific numerical values for accuracy or precision are provided for either the MyLabFive or its predicates in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document does not describe any specific clinical or technical test sets used to independently validate the MyLabFive's performance. The basis for equivalence is the shared design, software, and established performance of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As no specific test set is described, there is no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned. The MyLabFive is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or modifications to human reader performance. The document focuses on the imaging capabilities and operational modes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm is not discussed or presented. The device is an ultrasound system that produces images for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Since no specific performance study for the MyLabFive is detailed, the type of ground truth is not applicable. The basis for clearance is substantial equivalence, implying that the predicate devices' performance was considered adequate and that the MyLabFive performs similarly.

8. The sample size for the training set

This information is not provided. The MyLabFive is an imaging system, not an AI/ML device that would typically involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not provided for the reason stated in point 8.

Summary

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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 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)

{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(including Nerve Blocking)	N	N	N	N	N	N	N		N	4, 5, 6, 10
Musculo-skeletal Superficial(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.Doppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial (includingNerve 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

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

PA122

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined [3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

cleared via K070903

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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

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

LA332

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueEnhancement(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(including Nerve Blocking)	P	P	P	P	P	P	P	4, 5, 6, 10
Musculo-skeletal Superficial(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)

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

LA523P

Clinical Application	Mode of Operations
	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)	P	P	P		P	P	P		P	4,5,6,10
Musculo-skeletal Superficial(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)

・

(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	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial(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	ColorDoppler	AmplitudeDoppler	Combined[3]	TissueEnhancementImaging (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(including Nerve Blocking)	P	P	P	P	P	P	P	4, 5, 6
Musculo-skeletal Superficial(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

(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	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)	P	P	P		P	P	P		P	4,5,6
Musculo-skeletal Superficial(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(including Nerve Blocking)
Musculo-skeletal Superficial(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)

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

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CombinedTVM (3)	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial(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)

(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	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial(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	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (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(including Nerve Blocking)
Musculo-skeletal Superficial(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

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
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac (2)
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	4, 6, 8, 9
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

The TEEO22 probe was previously
cleared via K070903

(ப

(2)

ાંચા

(ના

(5)

[6]

[7]

(8)

(ત્રા

(10)

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CW + CFM + PD cmm MVièw XVicw QIMT 8tress Strain TP View

Lorna M. Wilson

Preseription Use _____________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

. V

{19}------------------------------------------------

TEE122

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)	P	P	P	P	P	P	P	P	P	4, 6, 8, 9
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

The TEE122 probe was previously
cleared via K070903

|||

(기

(3)

(4)

[의

[6]

្រប

[8]

lal

[1이

CMM MView XView QIMT

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD Stress Strain TP View

forne In Wha

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083882 510(k) Number _

{20}------------------------------------------------

IOE323

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(3)	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P	P	P	P	P	5, 6, 10
Intraoperative (Abdominal)	P	P	P	P	P	P	P	5, 6, 10
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, 9, 10
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)	P	P	P	P	P	P	P	4, 5, 6, 10
Musculo-skeletal Superficial(including Nerve Blocking)	P	P	P	P	P	P	P	4, 5, 6, 10
Other (Urological)

ﻨﺎ ﺍﻟﻤﺘﺎﺯ cleared via K070903

(1) [2| (३) (4| (SI િકા (7) (8) ાં છે (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 Stress Strain TP View

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Prescription Use _ . (Per 21 CFR 801.109)

・

{21}------------------------------------------------

LP323

	Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	5, 6, 10
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
Laparoscopic	P	P	P		P	P	P		P	5, 6, 10
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial(including Nerve Blocking)
Other (Urological)

The LP323 probe was previously
cleared via K051837 & K081794

(1) (외 (3) (4) (ខ) ાઠા [기 [8] al | 10|

Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD વખત MView XVicw QIMT

Stress

Straim

TP View

Arndt De Witte

Prescription Use
(Per 2.1 CFR 801.109)

ﺎ

. ﺮ ﺍﻟﻤﺮﺍﺟﻊ

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

{22}------------------------------------------------

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined[3]	TVM	TissueEnhancementImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	N	N	N	N	N	N	N		N	6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ [1]
Neonatal Cephalic
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)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional(including Nerve Blocking)
Musculo-skeletal Superficial (includingNerve Blocking)
Other (Urological)

he 1-5PA pro

submasion

(1) (2) (3) [4] (5) (6) (7) ម្រៀ છી || 이 Small Organs includes Breast, Thyroid and Testicles Cardiac is Adult and Pediatric Combined modes are: B + M + PW + CW + CFM + PD cmn MVicw .XView QIMT ' Stress Strain TP View

Roger M. Wern

Prescription Use J (Per 21 CFR 801.109)

(Division Sign-Off) 0 Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.