Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, A bdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).

Device Description

The MyLab15/20 is a compact console ultrasound system used to perform general The WYLao is a coulies. Its primary modes of operation are: B-Mode, M-Mode, PW Glaghoone and Color Flow Mapping and Tissue Enhancement Imaging (TEI). Dopper and Color 110 mages and time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images

AI/ML Overview

The provided 510(k) summary for the MyLab15/20 Just3D/4D Ultrasound System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study with specific metrics.

Therefore, the document does not contain the acceptance criteria and the results of a study designed to prove the device meets those criteria.

Here's why the requested information cannot be extracted from the provided text:

No Acceptance Criteria Defined: The document does not explicitly state any numerical or qualitative "acceptance criteria" against which the device's performance is measured. Instead, it relies on comparison to predicate devices to establish substantial equivalence.
No Performance Study Reported: There is no description of a dedicated study (clinical or analytical) designed to evaluate the device's performance against specific metrics. The tables provided are for "Comparison Chart for Substantial Equivalence" and "Indications for Use," which list features and approved applications, not performance results.
Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not ordinarily require a separate, hypothesis-driven performance study with pre-defined acceptance criteria.

Therefore, the bulk of the requested information (points 1-9) cannot be answered from the given text.

I can provide the information that is present in the document which touches upon aspects of equivalence:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated. The implicit acceptance criterion is "substantial equivalence" to the listed predicate devices in terms of intended use and technological characteristics, as determined by the FDA.
Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, resolution) are reported in the document. The performance is implied to be equivalent to the predicate devices.

Feature / Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (MyLab15/20 Just3D/4D)
General Characteristics	Substantially equivalent to predicate devices (K014168, K043588, K043455, K040060)
Fetal Application	Yes	Yes
Abdominal Application	Yes	Yes
Pediatric Application	Yes	Yes
Small Organ Application	Yes	Yes
Neonatal Cephalic Application	Yes	Yes
Cardiac Application	Yes	Yes
Transrectal Application	Yes	Yes
Transvaginal Application	Yes	Yes
Peripheral Vascular Application	Yes	Yes
Musculo-skeletal Application	Yes	Yes
Transducer Type
Linear	Yes	Yes
Convex	Yes	Yes
Phased array	No	No (Unlike some predicates which have it)
2D Freq MHz	Comparable range	2.7 - 15 (Predicates range 1-20 MHz)
Multifrequency	Yes	Yes
Special Probes	Similar functionality	Endocavity, Mechanically Driven 3D Convex Array
Biopsy attachments: Convex	Yes	Yes
Biopsy attachments: Linear	Yes	Yes
Imaging Modes
Real Time 2D	Yes	Yes
M-mode	Yes	Yes
PW Doppler	Yes	Yes
CW Doppler	No	No (Unlike some predicates which have it)
CFM Doppler	Yes	Yes
Amplitude Doppler	Yes	Yes
Triplex	Yes	Yes
3D/4D	Yes	Yes (includes Just3D and Just4D)
Monitor size (inches)	Comparable	15" CRT / 15" LCD
ECG	Optional	Optional
Digital archival capabilities	Yes	Yes
VCR & Video printers	Yes	Yes
M&A capabilities	Yes	Yes
Safety
Electrical safety	EN60601-1	EN60601-1

Regarding the study aspects:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. This document does not describe a performance study with a test set.
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): Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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: Not mentioned. This device is an ultrasound system with 3D/4D imaging, not specifically an AI-powered diagnostic tool in the sense of current AI submissions (which would typically involve MRMC studies).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an imaging system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Additional relevant information from the document:

Device Name: MyLab15/20 - Just3D and Just 4D Ultrasound System
Manufacturer: Pie Medical (represented by Carri Graham, Official Correspondent)
Date of Submission: November 10, 2005 (Received: November 15, 2005)
FDA Clearance Date: December 16, 2005
Predicate Devices:
- K014168 - Technos Esaote, S.p.A.
- K043588 - MyLab15/20 Ultrasound System Pie Medical (This appears to be an earlier version of the same system, indicating an upgrade or new features)
- K043455 - 8000Live Medison
- K040060 - G50 Siemens
Intended Uses (MyLab15/MyLab20): Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
New Indications (N): The submission introduces new indications for various transducers and applications. For example, the BC432P transducer supports new indications (N) for Fetal, Abdominal, and Pediatric applications across B, M, PW, Color Doppler, Amplitude Doppler, and combined modes, including N[2] for Tissue Enhancement Imaging (TEI), N[3] for 3D Imaging, and N[4] for 4D Imaging. This is how the 3D/4D capability is being introduced and cleared.

Acoustic Output Post-Clearance: The FDA letter (page 5) requires a post-clearance special report detailing acoustic output measurements based on production units. This is a common requirement for ultrasonic systems to ensure safety, but it's not a pre-market performance study for diagnostic accuracy.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for an ultrasound system, not a report on a performance study against specific acceptance criteria.

Summary

{0}------------------------------------------------

510(k) Summary MyLab15/20 Just3D/4D Pie Medical

DEC 1 6 2005

Ko53/54

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent7992 Castleway DriveIndianapolis, IN 46250Phone:	(317) 849-1916
Facsimile:	(317) 577-9070
Contact Person:	Carri Graham
Date:	November 10, 2005

807.92(a)(2)

Trade Name:	MyLab15/20 - Just3D and Just 4D Ultrasound System
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulsed echo imaging system 892.1560Ultrasonic pulsed Doppler imaging system 832.1550
Classification Number:	90IYO90IYN

807.92(a)(3)

Predicate Device(s)

K014168	Technos Esaote, S.p.A.
K043588	MyLab15/20 Ultrasound System Pie Medical
K043455	8000Live Medison
K040060	G50 Siemens

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

{1}------------------------------------------------

510(k) Summary MyLab15/20 Just3D/4D Pie Medical

Device Description 807.92(a)(4)

Intended Use(s) 807.92(a)(5)

{2}------------------------------------------------

GeneralCharacteristics	Esaote MyLab15/20	Medison 8000Live(K043455)	Siemens G50(K040060)
	Applications
Fetal	Yes	Yes	Yes
Abdominal	Yes	Yes	Yes
Pediatric	Yes	Yes	Yes
Small Organ	Yes	Yes	Yes
Neonatal Cephalic	Yes	Yes	Yes
Cardiac	Yes	Yes	Yes
Transrectal	Yes	Yes	Yes
Transvaginal	Yes	Yes	Yes
Peripheral Vascular	Yes	Yes	Yes
Musculo-skeletal(Conventional andsuperficial)	Yes	Yes	Yes

Comparison Chart for Substantial Equivalence

{3}------------------------------------------------

510(k) Summary MyLab15/20 Just3D/4D

Pie Medical

Pie Medical
GeneralCharacteristics	Esaote MyLab15/20	Medison 8000Live(K043455)	Siemens G50(K040060)
	Transducer Type
Linear	Yes	Yes	Yes
Convex	Yes	Yes	Yes
Phased array	No	Yes	Yes
2D Freq MHz	2.7 - 15	1 - 20	2 - 12
Multifrequency	Yes	Yes	Yes
Special probes	• Endocavity probe• MechanicallyDriven 3D ConvexArray	• Endocavity probe• MechanicallyDriven 3DConvex Array• CW DopplerProbe	• Endocavity probe• MechanicallyDriven 3DConvex Array• LaparoscopicCW DopplerProbe
	Biopsy attachments
Convex	Yes	Yes	Yes
Linear	Yes	Yes	Yes
	Imaging modes
Real Time 2D	Yes	Yes	Yes
M-mode	Yes	Yes	Yes
PW Doppler	Yes	Yes	Yes
CW Doppler	No	Yes	Yes
CFM Doppler	Yes	Yes	Yes
Amplitude Doppler	Yes	Yes	Yes
Triplex	Yes	Yes	Yes
3D/4D	Yes	Yes	Yes
Monitor size (inches)	• 15" CRTmonitor• 15" LCD	15" Color VGACRT Monitor	15" CRT monitor
ECG	Optional	Optional	Optional
Digital archivalcapabilities	Yes	Yes	Yes
VCR & Videoprinters	Yes	Yes	Yes
M&A capabilities	Yes	Yes	Yes
	Safety
Electrical safety	EN60601-1	EN60601-1	EN60601-1

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the logo.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pie Medical % Carri Graham The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

K053154 Re:

K033154
Trade Name: MyLab15/MyLab20 Ultrasound Imaging System (with 3D/4D Imaging Option) Regulation Number: 21 CFR 892.1550/1560/1570 Regulation Number: 21 CTN 072.1556.1556.1578.15 157.11.1 Ultrasonic pulsed echo
Regulation Name: Ultrasonic pulsed Doppler imaging provinstransducer imaging system; Diagnostic ultrasonic transducer. Regulatory Class: Il Product Code: IYN; IYO; ITX

Dated: November 10, 2005 Received: November 15, 2005

Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above We have reviewed your Section 510(x) premixally equivalens for use stated in the enclosure)
and we have determined the device is substantially equivalens for use stated in th and we have determined the devices marketed in interstate conneces prior to May 28, 1976, the enactment date to legally marketed predicate devices that have been recessified in accordance with the provisions
of the Medical Device Amendments, or to devices that have been receive syst of the Medical Device Amendments, or to devices that hard of the device, subject to the of the Federal Food, Drug, and Costlette Act (rec). general controls provisions of the Act. "The general connect processes, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the This determination of substantal equivalor upprise to as ed ed ed to be premarket notification:

Transducer Model Numbers

LA523; LA424; CA421P; CA421; CA621; BC432P; EC123; E8-5 R10

If your device is classified (see above) into either class III (PMA). III (PMA), it may be subject in the Code of Federal If your device is classified (see adove) natio cities in (course can be found in the Code of Federal to such additional controls. Existing major regulations an ouncements concerning your device in the Federal Register.

device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence of the Art or any Federal statures and Please be advised that FDA s Issualitar equirements of the Act of the Act or any Federal statutes and made a determination that your device comples with all the Act at 's requirements, including, including, including, including, regulations administered by other Federal agencies: You Multing (21 CFR Part 801); good manufacturing
but not limited to: registration and listing (21 CFR Part 807); and if but not limited to: registration and nismig (C.) C.F. Part 80); and I CFR Part 820); and If applicable, the
practice requirements as set forth in the quality of the A.S.A. A. practice requirements as sectorin in the quality of the Act); 21 CFR 1000-1050.
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-105

{5}------------------------------------------------

Page 2 - Ms. Graham

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, This determination of substantial equivalence is gamed on the information, including acoustic you submit a postclearance special report. "Ins report is G, (enclosed) of the Center's output measurements based on production this doviets, requested in 1 playessite Ultrasound September 30, 1997 " Information for wanting announg unaceptable values (e.g., acoustic Systems and Transducers. III the special report is meomplete or contaction units which as a output grouter considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently The special report should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarke in a elessification. This letter will allow you to begil marketing your device us cosenoed any an possible 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 If you desire specific advice for your device the regulation entitled, "Misbranding by reference to Office of Compliance at (240) 270-0120. You may obtain other general information on your responsibilities premarket notification" (21CPK Patt 807.97) - Tou may Count of Consumer Assistance at its toll-free under (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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

4.3 Indications for Use

							Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P [2]	P[3], N[4],N[5]
Abdominal		P	P	P		P	P		P [2]	P[3], N[4],N[5]
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		P [2]	P[3], N[4],N[5]
Small Organ (specify) [1]		P	P	P		P	P		P [2]	P[3], N[4]
Neonatal Cephalic		P	P	P		P	P		P [2]	P[3], N[4]
Adult Cephalic
Cardiac		P	P	P		P	P		P [2]	P[3]
Transesophageal
Transrectal		P	P	P		P	P		P [2]	P[3], N[4]
Transvaginal		P	P	P		P	P		P [2]	P[3], N[4]
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		P [2]	P[3], N[4]
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		P [2]	P[3]. N[4]
Musculo-skeletal Superficial		P	P	P		P	P		P [2]	P[3]. N[4]
Other (specify)

The following table provides the intended clinical use for the MyLab15/20:

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[1] Smart organs modes: B+M+PW+ CFM+Amplitude Doppler

[3] Tissue Enhancement Imaging (TEI)
[4] 3D Imaging

[5] 4D Imaging

Nancy C Gordon

(Division Sign (Off) Division il Reproductive, Abdominal, and R. . . . . cical Devices 510(x) Number .

Prescription Use

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

The following tables provide the intended clinical use for the MyLab15/20 probes in
ternation of the bounters: The forlowings
combination with the system:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P[2]	P[3], N[4]
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		P[2]	P[3], N[4]
Small Organ (specify) [1]		P	P	P		P	P		P[2]	P[3], N[4]
Neonatal Cephalic		P	P	P		P	P		P[2]	P[3], N[4]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		P[2]	P[3], N[4]
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		P[2]	P[3], N[4]
Musculo-skeletal Superficial		P	P	P		P	P		P[2]	P[3], N[4]

Transducer: LA523

Other (specify) other (specify)_______________________________________________________________________________________________________________________________________________________________

Additional Comments:

nal Comments:
[1] Small organs include Thyroid, Breast and Testicles.
[1] Small organs include Thyroid, Breast and Testicles.

[1] Small organs include Thyrold, Breast and Testeres:
[2] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler
[2] Applicable combined movies: (TED

[2] Applicable comotios Imaging (TEI)
[3] Tissue Enhancement Imaging (TEI)

[4] 3D Imaging

Frescription Use

Narryl Brogdon

(Division Sign Off) (Division Sign-Olf)
Division of Reproductive, Abdominal, Division in Janu Most Devices 510(k, mumber ---

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

Transducer: LA424

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N[2]	N[3], N[4]
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N		N	N		N[2]	N[3], N[4]
Small Organ (specify) [1]		N	N	N		N	N		N[2]	N[3], N[4]
Neonatal Cephalic		N	N	N		N	N		N[2]	N[3], N[4]
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N[2]	N[3], N[4]
Laparoscopic
Musculo-skeletalConventional		N	N	N		N	N		N[2]	N[3], N[4]
Musculo-skeletal Superficial		N	N	N		N	N		N[2]	N[3], N[4]
Other (specify)

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[ [ ] Small organs melude Thyton, Breast and Testation
[2] Applicable combined modes: B+M+PW+CW+CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+CW+CFM+Amplitude D

[2] Tissue Enhancement Imaging (TEI)

[4] 3D Imaging

ear [171

Nancy Hogdon

(Division Sign-Off) Sonon of Reproductive, Abdominal, : Deyings

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

Transducer: CA421P

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic										P[2], N[3]
Fetal		P	P	P		P	P		P[1]
Abdominal		P	P	P		P	P		P[1]	P[2], N[3]
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		P[1]	P[2], N[3]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

oner (speny)
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

onal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined Instaina (TEU

[1] Applicable enhancement Imaging (TEI)
(3) 3D Imaging

Nancy C. Hodgson

(Division Sigo-Off) Division of Reproductive, Abdominal, and Radiological Devices ち (((x) Number _

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

Transducer: CA421

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P[1]	P[2], N[3]
Abdominal		P	P	P		P	P		P[1]	P[2], N[3]
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P	P		P	P		P[1]	P[2], N[3]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

outer(spen);
N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

nal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: «TEV

[1] AppliceShancement Imaging (TEI)

[3] 3D Imaging

Nency C. hoodon
(Division Sign-Off)

Division of Reproductive, Abdominal, read Nogatur Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________ 315 5

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

Transducer: CA621

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal	N	N	N			N	N		N[1]	N[2], N[3]
Abdominal	N	N	N			N	N		N[1]	N[2], N[3]
Intraoperative (specify)
Intraoperative Neurological
Pediatric	N	N	N			N	N		N[1]	N[2], N[3]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

nal Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.

[2] Tissue Enhancement Imaging (TEI)
[3] 3D Imaging

Nancyc Brogdon

(Division Size (Nif) (Division Siznation of Sopen ructive, Abdominal,
Division of Sopen ructive, Alodominal, Division of the Status and Radiological Devices and Radiological Devices S and hatiloog
510(k) Number ---------------------------------------------------------------------------------------------------------------------------------------------------

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

Transducer: BC432P

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal	N	N	N	N		N	N		N[1]	N[2], N[3],N[4]
Abdominal	N	N	N	N		N	N		N[1]	N[2], N[3],N[4]
Intraoperative (specify)
Intraoperative Neurological
Pediatric	N	N	N	N		N	N		N[1]	N[2], N[3],N[4]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

Other (speny)
N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

onal Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler. [

[1] Appheable comment Imaging (TEI)
[3] 3D Imaging
(4) 4D Imaging

(Digitalia: ியுள்ள an: 1 .. 15 - 11 - 11 - 11 -

ff)
reproductive, Abdominal,
al Devices
K053154

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

Transducer: EC123

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		P[1]	P[2], N[3]
Transvaginal		P	P	P		P	P		P[1]	P[2], N[3]
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

Additional Comments:
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.

[2] Tissue Enhancement Imaging (TEI)

[3] 3D Imaging

Nancy C. Brogdon

(Division Sign L)" ifive, Abdominal. Division of Reer and Radiological - levices 510(k) Number ____

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

Transducer: E8-5 R10

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		P	P	P		P	P		P[1]	P[2], N[3]
Transvaginal		P	P	P		P	P		P[1]	P[2], N[3]
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

N=new indication; P=previously cleared by FDA; E= added under Appendix E

Additional Comments:

Additional Contined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: (TED

[2] Tissue Enhancement Imaging (TEI)

[3] 3D Imaging

R 100

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Nancy C. Hogdon

(Division Sign ાની Division of Reporductive, Abdomin and Radinlogica: 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.