Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound technology, image processing, and measurement functions without mentioning AI or ML.

Therapeutic

No.
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is for "Diagnostic ultrasound imaging or fluid flow analysis" and is a "diagnostic ultrasound system". It is designed to acquire and display data for diagnosis, not to provide therapy or treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and the "Device Description" section begins by calling it "a general purpose, mobile, software controlled, diagnostic ultrasound system." It also mentions being used to "make a diagnosis by competent health care professionals."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components like "transducers," "probes," and a "system control panel." It also describes acquiring ultrasound data, which requires hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is a diagnostic ultrasound system. Ultrasound imaging uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use describes imaging and analysis of various parts of the human body in vivo (within the living body).

Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoAce 5500 is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body for the following clinical applications: Fetal, Abdominal, Intra-Operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, and Muscular-Skeletal (conventional, superficial). It also includes imaging for guidance of biopsy and 3D imaging.

Transducer HL5-9 (7.5MHz/40mm Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Small Organ (thyroid, breast, testes), Neonatal Cephalic, Peripheral-Vascular, Muscular-Skeletal Conventional, and Muscular-Skeletal Superficial. Includes imaging for guidance of biopsy and 3D imaging.

Transducer L5-9/60mm (7.5MHz/60mm Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Small Organ (thyroid, breast, testes), Neonatal Cephalic, and Peripheral-Vascular. Includes imaging for guidance of biopsy and 3D imaging.

Transducer LT5-9 (Intraoperative 7.5MHz/40mm Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Intra-Operative (intra-abdominal organs), Peripheral-Vascular, Muscular-Skeletal Conventional, and Muscular-Skeletal Superficial. Includes imaging for guidance of biopsy and 3D imaging.

Transducer C2-4/30R (3.0MHz/30R/60D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Fetal, Abdominal (solid organs, aneurysms), and Cardiac. Includes 3D imaging.

Transducer HC2-5 (3.5MHz/40R/89D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Fetal, Abdominal (solid organs, aneurysms), and Pediatric. Includes imaging for guidance of biopsy and 3D imaging.

Transducer HC3-6 (3.5MHz/60R/60D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Fetal, Abdominal (solid organs, aneurysms), and Pediatric. Includes imaging for guidance of biopsy and 3D imaging.

Transducer C4-7 (5.0MHz/40R/60D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Fetal, Abdominal (solid organs, aneurysms), Small Organ (thyroid, breast, testes), Muscular-Skeletal Conventional, and Muscular-Skeletal Superficial. Includes imaging for guidance of biopsy and 3D imaging.

Transducer C4-9/10R (6.5MHz/10R/140D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Small Organ (thyroid, breast, testes), Neonatal Cephalic, and Peripheral-Vascular. Includes 3D imaging.

Transducer EC4-9/10R (Endocavity 6.5MHz/10R/140D, Curved Linear Array Probe)
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Trans-Rectal and Trans-Vaginal. Includes imaging for guidance of biopsy and 3D imaging.

Transducer ERW7/10AKP (Mechanical Sector Probe), 7.5 10 MHz
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Trans-Rectal. Includes imaging for guidance of biopsy and 3D imaging.

Transducer EW5/7KP (Mechanical Sector Probe), 5 & 7.5 MHz
Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Trans-Vaginal. Includes imaging for guidance of biopsy and 3D imaging.

Product codes

90-IYO, 90-ITX

Device Description

The SA 5500 System is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, 3D or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The SA 5500 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Eleven different models of transducers are available and any two array probes along with 1 mechanical sector probe may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate devices.

The SA 5500 uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 10.0 MHz.

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The SA 5500 supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-of-interest. The system provides the ability to perform remote viewing of images, without compression. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

Mentions image processing

Yes, "image enhancement processing" and "High-resolution images are provided by utilizing a technology called digital dynamic receive focusing."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal (includes infertility monitoring of follicle development, solid organs, aneurysms, intra-abdominal organs), Intra-operative (abdominal organs and peripheral vessel, neurological), Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (conventional, superficial).

Indicated Patient Age Range

Not Found (Implied: Fetal, Pediatric, Neonatal, Adult)

Intended User / Care Setting

Competent health care professionals (Implied: Clinical setting, e.g., hospital, clinic)

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)

K990970, K974813

Reference Device(s)

Not Found

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

992761 SA 6000C/UM 400C Ultrasound System

SEP 一 1988 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

Submitter's name, address, telephone number, contact person: Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588 M. T. Kwon President Telephone: 925.463.1830

Prepared June 11, 1999

Name of the device, including the trade or proprietary name if applicable, the common or 2) usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories

Proprietary Name: SonoAce 5500 Diagnostic Ultrasound System and Transducers.

Classification Names:	FR Number	Product Code
Ultrasound Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

1. Identification of the predicate or legally marketed device:
  Medison America, Inc. believes that SA 5500 Ultrasound System is substantially equivalent to the currently marketed SonoAce 6000C/UM 400 systems (K990970) and Voluson 530D (K974813).

4) Device Description:

The SA 5500 System is a general purpose, mobile, software controlled, diagnostic ultrasound

1

system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, 3D or in a combination of these modes. M-mode uses the sweep display method which has its images flow from the left to the right on the monitor The SA 5500 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The system has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Eleven different models of transducers are available and any two array probes along with 1 mechanical sector probe may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials are the same as those previously cleared in the predicate devices.

The SA 5500 uses digital beamforming technology, and supports a variety of Linear and Convex probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 2.0 MHz to 10.0 MHz.

The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis and Vascular Analysis.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The SA 5500 supports the Cine function (capable of storing up to 64 sequential images) and real-time zoom function to the region-ofinterest. The system provides the ability to perform remote viewing of images, without compression. Management of patient history is possible by image-filing function. Highresolution images are provided by utilizing a technology called digital dynamic receive focusing.

2

The SA 5500 has been designed to meet the following electromechanical safety standards:

EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical Equipment (
UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment (
C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment (
CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the ( declaration of the acoustic output of medical diagnostic ultrasonic equipment
EN 60601-1-2 (IEC 601-1-2,) European Norm, Collateral Standard: Electromagnetic ( Compatibility
Compliant with the European Medical Device Directive Certificate issued by TUV. (

Intended Use: ર)

SonoAce 5500 intended uses as defined FDA guidance documents are:

Fetal (includes infertility monitoring of follicle development) {
Abdominal {
( Intra-operative (abdominal organs and peripheral vessel, neurological)
{ Pediatric
{ Small Organ
{ Neonatal Cephalic
{ Adult Cephalic
( Cardiac
( Trans-Rectal
( Trans-Vaginal
( Peripheral-Vascular
( Muscular-Skeletal (conventional, superficial)

3

Typical examinations performed using the system are:

く General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall. (
( Pediatric scans of organs and bony structures.
( Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
( Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies. (
Prostate, prostate biopsy guidance, and rectal wall studies. (
( Neonatal head studies.
( Cardiac studies in adults and children.
く Biopsy guidance for tissue or fluid sampling.
( Conventional podiatry scans.
Intraoperative application including soft tissue structures. (

Technological Characteristics: ()

This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode, or 3D images. Transducer patient contact materials are biocompatible.

The device's acoustic output limits are:

All Applications:

	(Maximum Range)
ISPTA	720 mW/cm2
MI	1.9

The limits are the same as predicate Track 3 devices.

4

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1999

Medison America, Inc. C/o Carole Stamp TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

K992761 Re: SonoAce 5500 Diagnostic Ultrasound System Regulatory Class: II (two) Product Code: 90-IYO and 90-ITX Dated: August 16, 1999 Received: August 17, 1999

Dear Ms. Stamp:

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 SonoAce 5500 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

HL5-9 7.5MHz/40mm Linear Array L5-9/60mm 7.5MHz/60mm Linear Array LT5-9 Interoperative 7.5MHz/40mm Linear Array C2-4/3OR 3.0MHz/30R/60D Curved Linear Array HC2-5 3.5MHz/40R/89D Curved Linear Array HC3-6 3.5MHz/60R/60D Curved Linear Array C4-7 5.0MHz/40R/60D Curved Linear Array C4-9/10R 6.5MHz/10R/140D Curved Linear Array EC4-9/10R Endocavity 6.5MHz/l0R/140D Curved Linear Array ERW7/10AKP Mechanical Sector Probe 7.5 10MHz ERW5/7KP Mechanical Sector Probe 5 & 7.5 MHz

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

5

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.

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 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, " Misbranding by reference to premarket notification" (21 CFR Other qeneral information on your responsibilities under the Act may 807.97) . . be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address " http://www.fda.gov/cdrh/dsmamain.html" .

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at (301) 594-1212.

Sincerely yours,

David A. Leipman

for

CAPT. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

510(k) Number: Device Name: SonoAce 5500 Ultrasound System

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | Notes 3, 5 |
| Abdominal (See Note 1) | | N | N | | | | | | N | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | N | N | | | | | | N | Note 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Notes 3, 5 |
| Small Organ
(See Note 2) | | N | N | | | | | | N | Notes 3, 5 |
| Neonatal Cephalic | | N | N | | | | | | N | Note 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | Note 5 |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | N | N | | | | | | N | Notes 3, 5 |
| Trans-Vaginal | | N | N | | | | | | N | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E Other Indications or Modes

Other malrotation of Modocs
Note 1: Abdominal Solid organ

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs Note 5: 3D Imaging

Note 3. 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David G. Seymore

Division of Reproductive, Abdominal, EN and Radiological

510(k) Number K942761

7

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System HL5-9 (7.5MHz/40mm, Linear Array Probe) Transducer:

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*	Power
(Amp)
Doppler	Color
Velocity
Imaging	Combined
(B-M)	Other
(Specify)
Ophthalmic
Fetal
Abdominal (See Note 1)
Intra-Operative
(See Note 4)
Intra-Operative
Neurological
Pediatric
Small Organ
(See Note 2)		P	P				P	Notes 3, 5
Neonatal Cephalic		P	P				P	Note 5
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular		P	P				P	Note 5
Laparoscopic
Muscular-Skeletal
Conventional		P	P				P	Notes 3, 5
Muscular-Skeletal
Superficial		P	P				P	Notes 3, 5
Others(Specify)

Mode of Oneration

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs
Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Yaind A. Sesson

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

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109)

Indications for Use

Section 4.3, Page 2

8

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System L5-9/60mm (7.5MHz/60mm, Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | | | | | | P | Notes 2, 3, 5 |
| Neonatal Cephalic | | P | P | | | | | | P | Note 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | | | | | | P | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Oneration

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E Other Indications or Modes Note 1: Abdominal, Solid organs, aneurysms Note 2: For example: thyroid, breast, testes Notes 3, 5: Includes imaging for guidance of biopsy Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David G. Bertram

Division of Reproductive, Abdominal, EN and Radiological Devic

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Diagnostic Ultrasound Indications for Use Form

9

510(k) Number: Device Name: SonoAce 5500 Ultrasound System LT5-9 (Intraoperative 7.5MHz/40mm, Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
-(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|--------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative
(See Note 4) | | P | P | | | | | | P | Note 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | | | | | | P | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P | P | | | | | | P | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | P | P | | | | | | P | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Oneration

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms Note 2: For example: thyroid, breast, testes Notes 3, 5: Includes imaging for guidance of biopsy Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Seppam
Division Sign Off

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

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109)

Indications for Use

10

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System Transducer: C2-4/30R (3.0MHz/30R/60D, Curved Linear Array Probe)

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | Note 5 |
| Abdominal (See Note 1) | | P | P | | | | | | P | Note 5 |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | | | | | | P | Note 5 |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs
Note 5: 3D Imaging

Concurrence of CDRH, Office of Dey

David C. Grayson

Division of Reproductive, Abdominal, EN and Radiological Device

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109)

,

11

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System HC2-5 (3.5MHz/40R/89D, Curved Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | Notes 3, 5 |
| Abdominal (See Note 1) | | P | P | | | | | | P | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | P | Notes 3, 5 |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Deyice Evaluation(ODE)

David A. Symon

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

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109)

バ

12

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System HC3-6 (3.5MHz/60R/60D, Curved Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | Notes 3, 5 |
| Abdominal (See Note 1) | | N | N | | | | | | N | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Notes 3, 5 |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Deviçe Evaluation(ODE)

David C. Chapman

Reproductive, Abdominal, EN

510(k) Number K992761

13

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System Transducer: C4-7 (5.0MHz/40R/60D, Curved Linear Array Probe)

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | | | | | | P | Notes 3, 5 |
| Abdominal (See Note 1) | | P | P | | | | | | P | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | P | P | | | | | | P | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P | P | | | | | | P | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | P | P | | | | | | P | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs
Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

David M. Dymm

Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K992761

14

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System C4-9/10R (6.5MHz/10R/140D, Curved Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | | | | | | P | Note 5 |
| (See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | P | P | | | | | | P | Note 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | | | | | | P | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E Other Indications or Modes Note 1: Abdominal. Solid organs, aneurysms Note 2: For example: thyroid, breast, testes Notes 3, 5: Includes imaging for guidance of biopsy Note 4: Intra-Abdominal Organs Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel A. Hegman

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

510(k) Numb

Prescription Use (Per 21 CFR 801.109)

Indications for Use

Section 4.3, Page 9

15

510(k) Number:

Device Name: SonoAce 5500 Ultrasound System EC4-9/10R (Endocavity 6.5MHz/10R/140D, Curved Linear Array Probe) Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | |
| (See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Vaginal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K990970, SonoAce 6000C/ Ultramark 400C Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Edward C. Boykin

ve. Abdominal, ENT, Division c and Ra

510(k) Number K992761

16

510(k) Number: Device Name: SonoAce 5500 Ultrasound System ERW7/10AKP (Mechanical Sector Probe), 7.5 10 MHz Transducer:

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared by "VRW 77 AK" in K940942, , COMBISON 530 Ultrasound System ; E = added under Appendix E Other Indications or Modes Note 1: Abdominal, Solid organs, aneurysms Note 2: For example: thyroid, breast, testes Notes 3, 5: Includes imaging for guidance of biopsy Note 4: Intra-Abdominal Organs Note 5: 3D Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Ehrich A. Stegnan

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109)

Indications for Use

ﺴ

Section 4.3, Page 11

17

510(k) Number: Device Name: SonoAce 5500 Ultrasound System Transducer: EW5/7KP (Mechanical Sector Probe), 5 & 7.5 MHz

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler* | Power
(Amp)
Doppler | Color
Velocity
Imaging | Combined
(B-M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|-------------------|---------------------------|------------------------------|-------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal (See Note 1) | | | | | | | | | | |
| Intra-Operative
(See Note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(See Note 2) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared by "EW 5/7 K" in K940942, , COMBISON 530 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Notes 3, 5: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Concurrence of CDRH, Office of Device

Devices Evaluation (SDE)

David Ci. Glynn

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi

510(k) Number K992761

Prescription Use (Per 21 CFR 801.109

ー