SA6000II DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K012887
• Device Name: SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: MEDISON AMERICA, INC.
• Date Cleared: 2001-09-12 ( 15 days)
• Product Code: IYO
• Regulation Number: 892.1560

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle) Neonatal Cephalic Adult Cephalic Cardiac Trans-Rectal Trans-Vaginal Peripheral-Vascular Muscular-Skeletal (Conventional, Superficial) Typical examinations performed using the system are: 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. Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. Cardiac studies in adults and children. Biopsy guidance for tissue or fluid sampling. Conventional podiatry scans.

Device Description

The SA600011 scanner 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, or as a combination of these modes. SA600011 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. Five different models of transducers are available and any two 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. More detailed explanations of these functions and controls are included in the Operator's manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials are the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185). The SA6000II uses digital beamforming technology. The SA6000II supports a variety of Linear and Curved Linear Array probes for 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 MHz. These probes can be applied to a variety of fields such as fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA5500 Ultrasound System (K992761) and SA9900 Ultrasound System (K002185). SA6000II provides high quality images and various measuring functions. It can 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), APD (anteroposterior abdominal diameter), TTD (transverse trunk diameter), GS (gestational sac), etc. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The operating Modes of SA6000II are B, M, or as a combination of these modes. M-mode uses the sweep display method that has its images flow from the left to the right on the monitor. The SA6000II supports the Cine function (capable of storing up to 64 frames) and real-time zoom function to the region-of-interest. Management of patient history is possible by an image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

Predicate Devices

K992761, K002185

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound imaging technology and image processing techniques, but there is no mention of AI or ML.

Therapeutic

No.
The device is described as a "diagnostic ultrasound imaging" system used to acquire and display ultrasound data for diagnosis, not for therapeutic purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". Furthermore, the "Device Description" states "The SA600011 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system." and that it provides "analysis packages that provide information that is 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 the use of "transducers" and "probes," which are hardware components essential for acquiring ultrasound data. While it is software-controlled, it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states the device is a "diagnostic ultrasound system." Its function is to acquire ultrasound data and display it as images (B-mode, M-mode). It uses sound waves to create images of internal structures of the body.
• Intended Use: The intended uses listed are all related to imaging the human body directly, not analyzing samples taken from the body.
• No Mention of Specimen Analysis: There is no mention of analyzing biological specimens or using reagents, which are characteristic of IVD devices.

The device is a medical imaging device that provides information to healthcare professionals for diagnosis, but it does so by imaging the body directly, not by performing tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SA6000II intended uses as defined FDA guidance documents are:

• Fetal OB/GYN (
• ( Abdominal
• ( Pediatric
• Small Organ (breast, thyroid, testicle) (
• Neonatal Cephalic {
• ( Adult Cephalic
• Cardiac (
• { Trans-Rectal
• { Trans-Vaginal
• ( Peripheral-Vascular
• Muscular-Skeletal (Conventional, Superficial) {

Typical examinations performed using the system are:

• 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.
• Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. (
• Cardiac studies in adults and children. (
• ( Biopsy guidance for tissue or fluid sampling.
• ( Conventional podiatry scans.

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

For the SA6000II Ultrasound System with all transducers:
Clinical Application: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral -Vascular, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Includes imaging for guidance of biopsy, Intra-Abdominal Organs, 3D Imaging, Harmonic Imaging.

For the L5-9EC (Linear Array 7.5MHz/40mm/128elements) Transducer:
Clinical Application: Abdominal, Intra-Operative, Pediatric, Small Organ, Peripheral -Vascular, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Includes imaging for guidance of biopsy, Intra-Abdominal Organs, 3D Imaging.

For the L5-9ER (Linear Array 7.5MHz/50mm/128elements) Transducer:
Clinical Application: Abdominal, Intra-Operative, Pediatric, Small Organ, Peripheral -Vascular, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Includes imaging for guidance of biopsy, Intra-Abdominal Organs, 3D Imaging.

For the C2-4ES (Curved Linear Array 3.0MHz/20R/128elements) Transducer:
Clinical Application: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral -Vascular.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Intra-Abdominal Organs, 3D Imaging.

For the C3-7ED (Curved Linear Array 4.5MHz/50R/128elements) Transducer:
Clinical Application: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Includes imaging for guidance of biopsy, Intra-Abdominal Organs, 3D Imaging, Harmonic Imaging.

For the EC4-9ES (Curved Linear Array 6.5MlHz/10R/128elements) Transducer:
Clinical Application: Fetal, Abdominal, Intra-Operative, Pediatric, Small Organ, Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Peripheral -Vascular, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial.
Modes of Operation: B, M, and Combined (B-M).
Other Indications or Modes: Abdominal, Solid organs, aneurysms, For example: thyroid, breast, testes, Includes imaging for guidance of biopsy, Intra-Abdominal Organs, 3D Imaging.

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

90-IYO, 90-ITX

Device Description

The SA600011 scanner 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, or as a combination of these modes. SA600011 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.

Five different models of transducers are available and any two 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. More detailed explanations of these functions and controls are included in the Operator's manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials are the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185).

The SA6000II uses digital beamforming technology. The SA6000II supports a variety of Linear and Curved Linear Array probes for 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 MHz. These probes can be applied to a variety of fields such as fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA5500 Ultrasound System (K992761) and SA9900 Ultrasound System (K002185).

SA6000II provides high quality images and various measuring functions. It can 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), APD (anteroposterior abdominal diameter), TTD (transverse trunk diameter), GS (gestational sac), etc.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The operating Modes of SA6000II are B, M, or as a combination of these modes. M-mode uses the sweep display method that has its images flow from the left to the right on the monitor. The SA6000II supports the Cine function (capable of storing up to 64 frames) and real-time zoom function to the region-of-interest. Management of patient history is possible by an image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The SA6000II 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 く
• 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 60601-1-2,) European Norm, Collateral Standard: Electromagnetic ( Compatibility
• Compliant with the European Medical Device Directive Certificate issued by TUV. (

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-Rectal, Trans-Vaginal, Peripheral-Vascular, Muscular-Skeletal (Conventional, Superficial). Also mentioned are general abdominal and pelvic, organs, retro-peritoneal cavity, breasts, shoulders, thyroid, abdominal wall, carotid arteries, legs, arms, feet, penile artery, prostate, rectal wall, middle cerebral arteries, internal carotid artery, vertebral arteries, and tissue/fluid samples.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

Intended User / Care Setting

Competent health care professionals. Care setting can be inferred to be clinical environments where diagnostic ultrasound systems are used.

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.

K992761, K002185

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

§ 892.1560 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

SEP 1 2 2001

K0/2887

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: 1)

Gary J. Allsebrook, Consultant Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Telephone: [phone] Facsimile: 510-276-3559 Email: regman l @home.com

Prepared July 6, 2001

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:

SA600011 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

Identification of the predicate or legally marketed device: 3)

Medison America, Inc. believes that SA6000II Ultrasound System is substantially equivalent to the currently marketed SA5500 System (K992761) and SA9900 System (K002185)

Device Description: 4)

The SA600011 scanner 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, or as a combination of these modes. SA600011 also gives the operator the ability to measure

1

anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals.

Five different models of transducers are available and any two 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. More detailed explanations of these functions and controls are included in the Operator's manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials are the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185).

The SA6000II uses digital beamforming technology. The SA6000II supports a variety of Linear and Curved Linear Array probes for 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 MHz. These probes can be applied to a variety of fields such as fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA5500 Ultrasound System (K992761) and SA9900 Ultrasound System (K002185).

SA6000II provides high quality images and various measuring functions. It can 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), APD (anteroposterior abdominal diameter), TTD (transverse trunk diameter), GS (gestational sac), etc.

Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The operating Modes of SA6000II are B, M, or as a combination of these modes. M-mode uses the sweep display method that has its images flow from the left to the right on the monitor. The SA6000II supports the Cine function (capable of storing up to 64 frames) and real-time zoom function to the region-of-interest. Management of patient history is possible by an image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

The SA6000II 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 く
• CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the ( declaration of the acoustic output of medical diagnostic ultrasonic equipment

2

• EN 60601-1-2 (IEC 60601-1-2,) European Norm, Collateral Standard: Electromagnetic ( Compatibility
• Compliant with the European Medical Device Directive Certificate issued by TUV. (

5) Intended Use:

SA6000II intended uses as defined FDA guidance documents are:

• Fetal OB/GYN (
• ( Abdominal
• ( Pediatric
• Small Organ (breast, thyroid, testicle) (
• Neonatal Cephalic {
• ( Adult Cephalic
• Cardiac (
• { Trans-Rectal
• { Trans-Vaginal
• ( Peripheral-Vascular
• Muscular-Skeletal (Conventional, Superficial) {

Typical examinations performed using the system are:

• 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.
• Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries. (
• Cardiac studies in adults and children. (
• ( Biopsy guidance for tissue or fluid sampling.
• ( Conventional podiatry scans.

3

.

Technological Characteristics: 6)

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 disnayed as 2D and M-mode, Spectral Doppler, Color Doppler, Power Doppler, 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 I devices.

4

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2001

Medison America, Inc. % Mr. Mark Job Program Manager TUV Product Service, Inc. 1775 Old Highway 8 NW. Suite 104 NEW BRIGHTON MN 55112-1891

Re: K012887

Trade Name: SonoAce SA-6000II Diagnostic Ultrasound System Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: August 24, 2001 Received: August 28, 2001

Dear Mr. Job:

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 SA-6000II Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

L5-9EC/7.5MHz/Linear Array L5-9ER/7.5MHz/Linear Array C2-4ES/3.0MHz/Curved Linear Array C3-7ED/4.5MHz/Curved Linear Array EC4-9ES/6.5MHz/Curved Linear Array

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

5

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.

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 premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [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, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

6

Page 3 – Mr. Job

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy Brogdon

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

Enclosure(s)

7

01288 510(k) Number: / Device Name: SA600011 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 | | P | P | | | | | | P | Notes 3, 5, 6 |
| Abdominal (See Note 1) | | P | P | | | | | | P | Notes 3, 5, 6 |
| Intra-Operative
(See Note 4) | | P | P | | | | | | P | Note 5, 6 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | P | P | | | | | | P | Notes 3, 5, 6 |
| Small Organ
(See Note 2) | | P | P | | | | | | P | Notes 3, 5, 6 |
| Neonatal Cephalic | | P | P | | | | | | P | Note 5 |
| Adult Cephalic | | P1 | P1 | | | | | | P1 | Note 5 |
| Cardiac | | P | P | | | | | | P | Note 5 |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Vaginal | | P | P | | | | | | P | Notes 3, 5 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | P | | | | | | P | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P | P | | | | | | P | Notes 3, 5, 6 |
| Muscular-Skeletal
Superficial | | P1 | P1 | | | | | | P1 | Notes 3, 5, 6 |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K992761, SA5500 Uttrasound System, P1 = previously cleared in K002185, SA9900 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms(P)

Note 2: For example: thyroid, breast, testes (P)

Note 3: Includes imaging for guidance of biopsy (P, P1)

Note 4: Intra-Abdominal Organs(P)

Note 5: 3D Imaging (P, P1)

Note 6: Harmonic Imaging (P1)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy brogdon

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01288

ection 4.3, Page 1

1107

Indications for Use

8

510(k) Number:

Device Name: SA6000II Ultrasound System L5-9EC (Linear Array 7.5MHz/40mm/128elements) 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)		N	N						N	Notes 3, 5
Intra-Operative (See Note 4)		N	N						N	Notes 5
Intra-Operative Neurological
Pediatric		N	N						N	Notes 3, 5
Small Organ (See Note 2)		N	N						N	Notes 3, 5
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular		N	N						N	Note 5
Laparoscopic
Muscular-Skeletal Conventional		N	N						N	Notes 3, 5
Muscular-Skeletal Superficial		N	N						N	Notes 3, 5
Others(Specify)

Mode of Operation

N = new indication; P = previously cleared in K992761, SonoAce 5500 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy Langdon

(Divisi Divis and Ra 510(k) Nu

Prescription Use (Per 21 CFR 801.109)

Indications for Use

ection 4.3, Page 2

9

510(k) Number:

Device Name: SAS000Il Ultrasound System

L5-9ER (Linear Array 7.5MHz/50mm/128elements) 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) | | N | N | | | | | | N | Notes 3, 5 |
| Intra-Operative
(See Note 4) | | N | N | | | | | | N | Notes 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Notes 3, 5 |
| Small Organ
(See Note 2) | | N | N | | | | | | N | Notes 3, 5 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K992761, SonoAce 5500 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy Hodgson

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, minal.
and Radiological Devices
510(k) Number
KO 1288

Section 4.3, Page 3

10

510{k) Number:

Device Name: SA6000Il Ultrasound System

C2-4ES (Curved Linear Array 3.0MHz/20R/128elements) 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 | Note 5 |
| Abdominal (See Note 1) | | N | N | | | | | | N | Note 5 |
| Intra-Operative
(See Note 4) | | N | N | | | | | | N | Note 5 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Note 5 |
| Small Organ
(See Note 2) | | N | N | | | | | | N | Note 5 |
| Neonatal Cephalic | | N | N | | | | | | N | Note 5 |
| Adult Cephalic | | N | N | | | | | | N | Note 5 |
| Cardiac | | N | N | | | | | | N | Note 5 |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | Note 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K992761, SonoAce 5500 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Nancy bradsha
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproduct and Radiological Device 510(k) Number

Indications for Use

Section 4.3, Page 4

11

510(k) Number:

Device Name: SA600011 Ultrasound System C3-7ED (Curved Linear Array 4.5MHz/50R/128elements) 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, 6 |
| Abdominal (See Note 1) | | N | N | | | | | | N | Notes 3, 5, 6 |
| Intra-Operative
(See Note 4) | | N | N | | | | | | N | Notes 5, 6 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Notes 3, 5, 6 |
| Small Organ
(See Note 2) | | N | N | | | | | | N | Notes 3, 5, 6 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Notes 3, 5, 6 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Notes 3, 5, 6 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K992761, SonoAce 5500 Ultrasound System ; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Naveen C. Beoydore
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

Section 4.3, Page 5

Indications for Use

12

510(k) Number:

Device Name: SA60001! Ultrasound System EC4-9ES (Curved Linear Array 6.5MlHz/10R/128elements) 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) | | N | N | | | | | | N | Notes 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 | Notes 5 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| 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 | Notes 3, 5 |
| Laparoscopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Notes 3, 5 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Notes 3, 5 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

N = new indication; P = previously cleared in K992761, SonoAce 5500 Ultrasound System; E = added under Appendix E

Other Indications or Modes

Note 1: Abdominal, Solid organs, aneurysms

Note 2: For example: thyroid, breast, testes

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Note 5: 3D Imaging

Note 6: Harmonic Imaging

Concurrence of CDRH, Office of Device Evaluation(ODE)

Yarriyl Shroader
(Division Sign-Off)

Division of Reproductive and Radiological Device 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Indications for Use

Section 4.3, Page 6