7250 ULTRASOUND IMAGING SYSTEM

• K Number: K982444
• Device Name: 7250 ULTRASOUND IMAGING SYSTEM
• Manufacturer: BIOSOUND ESAOTE, INC.
• Date Cleared: 1998-10-06 ( 84 days)
• Product Code: IYO
• Regulation Number: 892.1560

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.

Device Description

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping and Amplitude Doppler, The MOD.7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MOD. 7250 can drive annular array, phased, convex and linear array probes. In addition. Mod.7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simoson rule: specifically, it can be used to measure volumes of irregular structures since it does not reguire a geometrical assumption. The MOD.7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, MOD.7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.

Predicate Devices

K944287

Reference Devices

K953716

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound imaging modes, hardware features, and user interface, with no mention of AI or ML capabilities.

Therapeutic

No.
The intended use explicitly states "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" mentions that it is "used to perform non-invasive diagnostic general ultrasound studies."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical ultrasound system with hardware components such as probes, displays, keyboard, and storage drives, in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that performs imaging on the human body, not on samples taken from the human body.
• Device Description: The description details an ultrasound system that uses probes to interact with the body and generate images. This is consistent with in-vivo imaging, not in-vitro testing of samples.
• Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.

Therefore, this device is an in-vivo diagnostic imaging system, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical applications listed include: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast, Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.
Modes of Operation: B, M, PWD, CWD, Color Doppler CFM, Amplitude Doppler PD, Color Velocity Imaging.

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

90IYN, 90IYO

Device Description

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping and Amplitude Doppler, The MOD.7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.

The MOD. 7250 can drive annular array, phased, convex and linear array probes. In addition. Mod.7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simoson rule: specifically, it can be used to measure volumes of irregular structures since it does not reguire a geometrical assumption.

The MOD.7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, MOD.7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Cardiac (Transthoracic), Cardiac (Transesophageal), Vascular, Abdominal, Fetal, Adult Cephalic, Neonatal Cephalic/Small organ, Endovaginal, Endorectal. Small organs include Thyroid, Breast and Testicles.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s)

K944287

Reference Device(s)

K953716

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

0

K982444

892.1550

892.1560

OCT 6 1998

Safety and Effectiveness Summary 7250 Ultrasound Imaging System Biosound Esaote

Safety and Effectiveness 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

Colleen Hittle, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 [phone] Phone: [phone] Facsimile:

Colleen Hittle Contact Person:

Date: July 2, 1998

807.92(a)(2)

7250 Ultrasound Imaging System Trade Name: Ultrasound Imaging System Common Name: Classification Name(s): Ultrasonic pulsed doppler imaging system Ultrasonic pulsed echo imaging system

90IYN 90IYO

7050 (AU3)

Classification Number:

807.92(a)(3)

Predicate Device(s)

Esaote

K944287

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

1

Safety and Effectiveness Summary 7250 Ultrasound Imaging System Biosound Esaote

807.92(a)(4)

Device Description

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping and Amplitude Doppler, The MOD.7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.

The MOD. 7250 can drive annular array, phased, convex and linear array probes. In addition. Mod.7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simoson rule: specifically, it can be used to measure volumes of irregular structures since it does not reguire a geometrical assumption.

The MOD.7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, MOD.7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through

807.92(a)(5)

the keyboard.

Intended Use(s)

ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.

2

K982444 P3 of 3

Safety and Effectiveness Summary 7250 Ultrasound Imaging System Biosound Esaote

	Comparison Chart for Substantial Equivalence
	7250	7050
Electrical Safety	EN60601-1	EN60601-1
Ultrasound Safety	Track 3 (Acoustic Output Display)	Track 3 (Acoustic Output Display)
Intended Use
• Cardiac (Transthoracic)	YES	YES
• Cardiac (Transesophageal)	YES (Multiplane)	YES (Monoplane)
• Vascular	YES	YES
• Abdominal	YES	YES
• Fetal	YES	YES
• Adult Cephalic	YES	YES
• Neonatal Cephalic/Small organ	YES	YES
• Endovaginal	YES (Sagittal & Transverse Planes)	YES (Sagittal & Transverse Planes)
• Endorectal	YES (Sagittal & Transverse Planes	YES (Sagittal & Transverse Planes
Probe Technology
• Annual Array	YES	YES
• Electronical Array	YES	YES
• Bi-Scan Probes	YES	NO
• Doppler Probes	YES	YES
Modes of operation	2D, M-Mode, PW, CW, CFM, Amplitude Doppler	2D, M-Mode, PW, CW, CFM, Amplitude Doppler
Imaging Frequencies	2.5, 3.5, 5.0, 7.5, 10 MHz	2.5, 3.5, 5.0, 7.5, 10 MHz
CFM/Doppler Frequencies	2.0, 2.5, 3.3, 5.0, 6.6 MHz	2.0, 2.5, 3.3, 5.0, 6.6 MHz
Biopsy Guidance	YES	YES
• ABS11 & ABS13 use	General Purpose	General Purpose
• ABS12 use	Transrectal/transvaginal	Transrectal/transvaginal
• Biopsy Line Depth marker	1 cm	1 cm
• Needle guide angle	ABS11: 25-45°
ABS12: fixed
ABS13: 30-50°	ABS11: 25-45°
ABS12: fixed
ABS13: 30-50°
Display Type	SVGA	RGB
Digital Archival Capabilities	YES	YES
VCR/Page Printer	YES	YES
M&A Capabilities	Cardiac, Vascular, Fetal and general purpose measurements	Cardiac, Vascular, Fetal and general purpose measurements

3

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three wing-like shapes. The bird is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

OCT ୧ 1098

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Colleen Hittle Official Correspondent Biosound Esaote 8000 Castleway Drive Indianapolis, IN 46250

Re: K982444 7250 Ultrasound Imaging System Regulatory Class: II Product Code: 90 IYO/21 CFR 892.1560 Dated: July 2, 1998 Received: July 14, 1998

Dear Ms. Hittle:

We have reviewed your Section 510(k) 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 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 Mod. 7250, as described in your premarket notification:

Transducer Model Number

PA020 CA11 7510 AA-C LA13 BLA023 5 MHz TEE TRT12

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

4

Page 2 - Colleen Hittle

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. position on this use.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and 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 The FDA finding of substantial equivalence of your ... . premarket notification. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

5

Page 3 - Colleen Hittle

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at [phone].

Sincerely yours,

David A. Szymon
for Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

6

Mod.7250

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler
CFM	Amplitude
Doppler
PD	Color
Velocity
Imaging	Combined
(specify)	Other (specify)
Ophthalmic
Fetal		N	N	N		N	N		See
comments
Abdominal		N	N	N		N	N		See
comments
Intraoperative (specify)
Intraoperative Neurological
Pediatric		N	N	N	N	N	N		See
comments
Small Organ (specify) [1]		N	N	N	N	N	N		See
comments
Neonatal Cephalic		N	N	N	N	N	N		See
comments
Adult Cephalic		N	N	N	N	N	N		See
comments
Cardiac		N	N	N	N	N	N		See
comments
Transesophageal		N	N	N	N	N	N		See
comments
Transrectal		N	N	N		N	N		See
comments
Transvaqinal		N	N	N		N	N		See
comments
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		See
comments	N[2]
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)
		Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler
CFM	Amplitude
Doppler
PD	Color
Velocity
Imaging	Combined
(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		N	N	N	N	N	N		See
comments
Cardiac		N	N	N	N	N			See
comments
Transesophageal
Transrectal
Transvaginal
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: [1] Small organs include Thyroid, Breast and Testicles. [2] This unit manages Bi-scan

probes for volumetric acquisitions from which any 2D tomographic image can be displayed.

Applicable combined modes: B+M+PW+CW+CFM+PD

Daniel A. Segarra
(Division Sign-Off)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF sion of Reproductive, Abdominal, ENT, concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

510(k) Number

11

7

Transducer: PA020

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body or follows:

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

Additional Comments: / Applicable combined modes: B+M+PW+CW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS JINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K982444

8

K982444

Transducer: CA11

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler
CFM | Amplitude
Doppler
PD | Color
Velocity
Imaging | Combined
(specify) | Other (specify) |
|-----------------------------|---|---|---|-----|-----|-------------------------|----------------------------|------------------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | See
comments | | |
| Abdominal | P | P | P | P | | P | P | See
comments | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify)
: | | | | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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

Additional Comments: This transducer has been previously cleared by FDA with the AU3 unit (K944287) for uses indicated as "P". Applicable combined modes: B+M+PW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Sijim

---

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT. and Radiological Devices

510(k) Number K482444

9

K982494

Diagnostic Ultrasound Indications for Use Form

Transducer: 7510 AA-C

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler
CFM | Amplitude
Doppler
PD | Color
Velocity
Imaging | Combined
(specify) | Other (specify) |
|-----------------------------|---|---|---|-----|-----|-------------------------|----------------------------|------------------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | N | N | N | N | N | N | | | See
comments | |
| Small Organ (specify) [1] | P | P | P | P | P | P | | | See
comments | |
| Neonatal Cephalic | P | P | P | P | P | P | | | See
comments | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | N | N | N | N | N | N | | | See
comments | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | | | See
comments | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| 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. This transducer has been previously cleared by FDA with the AU3 unit (K944287). Applicable combined modes: B+M+PW+CFM

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982444.

Warr

10

Transducer: LA13

	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	Color
Doppler
CFM	Amplitude
Doppler
PD	Color
Velocity
Imaging	Combined
(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify) [1]	N	N	N	N		N	N		See
comments
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		See
comments
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as for

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

Additional Comments: [1] Small organs include Thyroid, Breast and Testicles. This transducer has been previously

cleared by FDA with the AU3 unit (K944287). Applicable combined modes: B+M+PW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lopson

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

11

Transducer: BLA023

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler
CFM	Amplitude
Doppler
PD	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
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		See
comments	N [1]
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

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

Additional Comments: [1]: This probe can be used to acquire volumetric datasets from which any 2D tomographic

plane can be then visualized. Applicable combined modes: B+M+PW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Severson

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

12

Transducer: 5 MHz TEE

Clinical Application		Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler
CFM	Amplitude
Doppler
PD	Color
Velocity
Imaging	Combined
(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		N	N	N	N	N			See
comments
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

: 1 ต

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

Additional Comments: / Applicable combined modes: B+M+PW+CW+CFM

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Legerson

(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

13

Transducer: TRT12

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler
CFM | Amplitude
Doppler
PD | Color
Velocity
Imaging | Combined
(specify) | Other (specify) |
|-----------------------------|---|---|---|-----|-----|-------------------------|----------------------------|------------------------------|-----------------------|-----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | See
comments | |
| Transvaginal | | P | P | P | | P | P | | See
comments | |
| 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: This transducer has been previously cleared by FDA with the AU3 unit (K953716).

Applicable combined modes: B+M+PW+CFM+PD

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leggett

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K982444