Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and features.

Therapeutic

No
The device is described as an ultrasound system for diagnostic studies, not for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that the device is an ultrasound system intended to be used by a physician to perform "general diagnostic ultrasound studies".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact console ultrasound system," which is a hardware device. The description also details various imaging modes and probes, further indicating a hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the system is used by a physician to perform general diagnostic ultrasound studies. These studies involve imaging the internal structures of the body.
Device Description: The description details an ultrasound system with various imaging modes (B-Mode, M-Mode, Doppler, etc.) and the ability to produce 2D, 3D, and 4D images. This is consistent with an imaging device used for diagnosis based on visual interpretation of anatomical structures.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. The provided information does not mention any analysis of specimens or any in vitro procedures.

Therefore, the Esaote MyLab15/MyLab20 is a medical imaging device used for in vivo (within the body) diagnostic purposes, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

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

90IYO, 90IYN, ITX

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small organ (Thyroid, Breast, Testicles), Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K014168, K043588, K043455, K040060

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

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 Correspondent
7992 Castleway Drive
Indianapolis, IN 46250

Phone:	(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 892.1560
Ultrasonic pulsed Doppler imaging system 832.1550
Classification Number:	90IYO
90IYN

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)

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

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

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).

2

| General
Characteristics | 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 and
superficial) | Yes | Yes | Yes |

Comparison Chart for Substantial Equivalence

3

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

Pie Medical

Pie Medical
General
Characteristics	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
• Mechanically
Driven 3D Convex
Array	• Endocavity probe
• Mechanically
Driven 3D
Convex Array
• CW Doppler
Probe	• Endocavity probe
• Mechanically
Driven 3D
Convex Array
• Laparoscopic
CW Doppler
Probe
	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" CRT
monitor
• 15" LCD	15" Color VGA
CRT Monitor	15" CRT monitor
ECG	Optional	Optional	Optional
Digital archival
capabilities	Yes	Yes	Yes
VCR & Video
printers	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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional		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 ---

14

8

Transducer: LA424

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional		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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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

17

11

Transducer: CA621

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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

Na

(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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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

$\checkmark$

Nancy C. Hogdon

(Division Sign ાની Division of Reporductive, Abdomin and Radinlogica: Devices
510(k) Number _______________________________________________________________________________________________________________________________________