SONOACE 6000/ ULTRAMARK 400

• K Number: K981510
• Device Name: SONOACE 6000/ ULTRAMARK 400
• Manufacturer: MEDISON AMERICA, INC.
• Date Cleared: 1998-05-08 ( 10 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 - Intraoperative (abdominal organs) - Small Organs (breast, thyroid, testicle) - Pediatric - Neonatal Cephalic - Trans-Vaginal - Trans-Rectal - Peripheral Vascular - Cardiac - Musculo-skeletal (conventional) - Musculo-skeletal (superficial) Includes imaging for guidance of biopsy.

Device Description

The SA6000/Ultramark 400 scanner is a multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based (OS:Windows NT) parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks. Eight 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. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer. The SA-6000/Ultramark 400 uses digital beamforming technology. SA-6000/Ultramark 400 supports a variety of Linear and Convex 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 3.5 MHz to 7.5 MHz. SA-6000/Ultramark 400 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of SA-6000/Ultramark 400 are B, B/B, B/M, and M. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.

Predicate Devices

K924432, K961459

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on conventional ultrasound technology, digital beamforming, and image processing techniques without mentioning AI or ML.

Therapeutic

No
The device is described as a diagnostic ultrasound imaging system, used for imaging and analysis, not for treatment.

Diagnostic

Yes.

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "cart-mounted console" containing an "ultrasound generator/receiver" and supports various "transducers" and "probes," which are all hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this is an ultrasound imaging system used for in vivo (within the living body) imaging and fluid flow analysis. It directly interacts with the patient's body using transducers.
• The device description focuses on imaging technology and applications within the body. It describes transducers, beamforming, image processing, and various anatomical sites for imaging.
• There is no mention of analyzing biological samples. The device does not process blood, urine, tissue samples, or any other specimen taken from the body.

Therefore, this device 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

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

• Fetal OB/GYN
• Abdominal
• Intraoperative (abdominal organs)
• Small Organs (breast, thyroid, testicle)
• Pediatric
• Neonatal Cephalic
• Trans-Vaginal
• Trans-Rectal
• Peripheral Vascular
• Cardiac
• Musculo-skeletal (conventional)
• Musculo-skeletal (superficial)

Typical examinations performed using the system are:

• General abdominal and pelvic studies including organ surveys, assessment, and retroperitoneal cavity studies.
• Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
• Pediatric scans of organs, superficial, and bony structures.
• Monitoring procedures for infertility studies (other than in vitro fertilization).
• First, second and third trimester pregnancy studies.
• Neonatal head studies.
• Podiatry scans of superficial structures including muscles, tendons and bones.
• General cardiac studies in adults.
• Prostate, bladder and rectum visualization.
• Intraoperative application including soft tissue structures.

Product codes

90-IYO, 90-ITX

Device Description

The SA6000/Ultramark 400 scanner is a multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based (OS:Windows NT) parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks.

Eight 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. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer.

The SA-6000/Ultramark 400 uses digital beamforming technology. SA-6000/Ultramark 400 supports a variety of Linear and Convex 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 3.5 MHz to 7.5 MHz. SA-6000/Ultramark 400 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of SA-6000/Ultramark 400 are B, B/B, B/M, and M. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device, Medison 1500 (K924432, Nov. 24, 1993).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

• Fetal
• Abdominal
• Intraoperative (abdominal organs)
• Small Organs (breast, thyroid, testicle)
• Pediatric
• Neonatal Cephalic
• Trans-Vaginal
• Trans-Rectal
• Peripheral Vascular
• Cardiac
• Musculo-skeletal (conventional)
• Musculo-skeletal (superficial)

Indicated Patient Age Range

Fetal, Pediatric, Neonatal, Adult

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)

K924432, K961459

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

510(k) Premarket Notification

8 1998 MAY

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) Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588 Bob Leiker Vice President, Regulatory and Quality Telephone: [phone]

Prepared April 15, 1998

Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

SonoAce 6000 Diagnostic Ultrasound System and Transducers. Also called Ultramark 400m Diagnostic Ultrasound System and Transducers.

Classification Names:

Ultrasound Pulsed Echo Imaging System Diagnostic Ultrasound Transducer

Identification of the predicate or legally marketed device: Medison America, Inc believes that SA 6000 Ultrasound system is substantially equivalent to the currently marketed Medison SA 1500, K924432 and ATL Level 10 HDI Ultrasound, K961459 diagnostic ultrasound systems.

510(k) Summary of Safety and Effectiveness

FR Number 892.1560

892.1570

Page 1

1

Device Description: 4)

Scanner SA6000//Ultramark 400:

The SA6000/Ultramark 400 scanner is a multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based (OS:Windows NT) parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks.

Eight 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. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer.

The SA-6000/Ultramark 400 uses digital beamforming technology. SA-6000/Ultramark 400 supports a variety of Linear and Convex 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 3.5 MHz to 7.5 MHz. SA-6000/Ultramark 400 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of SA-6000/Ultramark 400 are B, B/B, B/M, and M. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device, Medison 1500 (K924432, Nov. 24, 1993).

Intended Use:

ર)

• Fetal OB/GYN .
• . Abdominal
• Intraoperative (abdominal organs) .
• Small Organs (breast, thyroid, testicle) .
• Pediatric .

2

• Neonatal Cephalic .
• Trans-Vaginal .
• Trans-Rectal .
• Peripheral Vascular .
• Cardiac .
• Musculo-skeletal (conventional) .
• . Musculo-skeletal (superficial)

Typical examinations performed using the system are:

• General abdominal and pelvic studies including organ surveys, assessment, and . retroperitoneal cavity studies.
• Study of small parts and superficial structures including breasts, shoulders, thyroid, and the . abdominal wall.
• Pediatric scans of organs, superficial, and bony structures. .
• Monitoring procedures for infertility studies (other than in vitro fertilization). .
• First, second and third trimester pregnancy studies. .
• Neonatal head studies. .
• Podiatry scans of superficial structures including muscles, tendons and bones. .
• . General cardiac studies in adults.
• Prostate, bladder and rectum visualization. .
• Intraoperative application including soft tissue structures. .

Technological Characteristics: 0

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 images. Scanhead patient contact materials are biocompatible.

The device's acoustic output limits are:

All Applications:

	(Maximum Range)
ISPTA,3	94 mW/cm2
MI	1.9

The limits are the same as predicate Track 1 devices.

3

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 the department's symbol, which consists of a stylized human figure with three faces in profile, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medison America, Inc. C/O Carole Stamp TUV. Product Service 1775 Old Highway 8, Suite 104 New Brighton, MN 55112-1891

K981510 Re :

Trade Name: SonoAce 6000/Ultramark™ 400 Diagnostic Ultrasound System Regulatory Class: II Product Code: 90-IYO and 90-ITX Dated: April 27, 1998 Received: April 28, 1998

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 6000/Ultramark™ 400 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number 7.5 MHz/40mm Linear Array 7.5 MHz/60mm Linear Array 3.0 MHz/30R/60D Curved Linear Array 3.5 MHz/40R/89D Curved Linear Array 5.0 MHz/40R/60D Curved Linear Array 6.5 MHz/10R/140D (Endocavity) Curved Linear Array 6.5 MHz/10R/140D Curved Linear Array Inter-Operative 7.5 MHz/40mm 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 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) requlation (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 requlatory 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 requlations.

4

Page 2 - Ms. Corole Stamp

Please be advised that the determination above is based on the fact that no riease be advised that the decemmatir ass safe and effective for in vitro meanous actives nave been acksmabilical blood sampling, nor have any devices in been marketed for these uses in interstate commerce prior to May 28, 1976, or becil marketed for chere as an al 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 pleasantisas and 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 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 (characound) of ing 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 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".

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

Sincerely yours,

Stenis M. Sezenn

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

Enclosure (s)

5

510(k) Number:

SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name:

Indications for 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 | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | Note 3 |
| Abdominal | | N | N | | | | | | N | Note 1
Note 3 |
| Intra-Operative (Specify) | | N | N | | | | | | N | Note 4 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | Note 3 |
| Small Organ | | N | N | | | | | | N | Note 3
Note 2 |
| Neonatal Cephalic | | N | N | | | | | | N | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | N | N | | | | | | N | Note 3 |
| Trans-Vaginal | | N | N | | | | | | N | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Note 3 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Note 3 |
| Others (Specify) | | | | | | | | | | |

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

Note 1: Abdominal, Solid organs, aneurysms.

Note 2: Small Organ : breast, thyroid, testes.

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Segner

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

510(k) Number

6

510(k) Number:
Device Name:	SonoAce 6000/Ultramark™ 400 Ultrasound System
Transducer:	7.5 MHz/40mm Linear Array Probe

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | N | N | | | | | | N | Note 3
Note 2 |
| Neonatal Cephalic | | N | N | | | | | | N | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Note 3 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Note 3 |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

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

Note 2: Small Organ : breast, thyroid, testes. Note 3: Includes imaging for guidance of biopsy

David A. Seymann

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

7

510(k) Number:
Device Name:	SonoAce 6000/Ultramark™ 400 Ultrasound System
Transducer:	7.5 MHz/60mm Linear Array Probe

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | N | N | | | | | | N | Note 2
Note 3 |
| Neonatal Cephalic | | N | N | | | | | | N | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | N | | | | | | N | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

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

Note 2: Small Organ : breast, thyroid, testes. Note 3: Includes imaging for guidance of biopsy

David A. Soyarsm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number

8

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: Transducer: 3.0MHz/30R/60D Curved Linear Array Probe

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | Note 1 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

Mode of Operation

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

Note 1: Abdominal, Solid organs, aneurysms

Daniel A. Segner
(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number K981510

9

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: Transducer: 3.5MHz/40R/89D Curved Linear Array Probe

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

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | N | | Note 3 |
| Abdominal | | N | N | | | | | N | | Note 1
Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | N | | | | | N | | Note 3 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

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

Note 1: Abdominal, Solid organs, aneurysms. Note 3: Includes imaging for guidance of biopsy

David A. Syverson
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Devic

510(k) Number K981510

10

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: 5.0MHz/40R/60D Curved Linear Array Probe Transducer:

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

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (B - M)	Other (Specify)
Opthalmic
Fetal		N	N						N	Note 3
Abdominal		N	N						N	Note 1
Note 3
Intra-Operative (Specify)
Intra-Operative
Neurological
Pediatric
Small Organ		N	N						N	Note 2
Note 3
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral -Vascular
Laparascopic
Muscular-Skeletal
Conventional		N	N						N	Note 3
Muscular-Skeletal
Superficial		N	N						N	Note 3
Others (Specify)

Mode of Operation

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

Note I: Abdominal, Solid organs, aneurysms. Note 2: Small Organ : breast, thyroid, testes. Note 3: Includes imaging for guidance of biopsy . . . .

David A. Seymann
(Division Sign-Off)

Division of Reproductive, Abdominal, E. and Radiological Dev

510(k) Number K981570

11

Indications for Use -

Ultrasound Device Indications Statement

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: 6.5MHz/10R/140D (Endocavity) Curved Linear Array Probe Transducer:

Indications for 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 | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | N | N | N | | | | | | N | Note 3 |
| Trans-Vaginal | N | N | N | | | | | | N | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

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

Note 3: Includes imaging for guidance of biopsy

Daniel A. Slayton

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

510(k) Number K981570

12

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: 6.5MHz/10R/140D Curved Linear Array Probe Transducer:

Indications for 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 | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | N | N | N | | | | | | N | Note 2 |
| Neonatal Cephalic | N | N | N | | | | | | N | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | N | N | N | | | | | | N | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
Superficial | | | | | | | | | | |
| Others(Specify) | | | | | | | | | | |

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

Note 2: Small Organ : breast, thyroid, testes.

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Syreman

Reproductive, Abdominal, E

13

510(k) Number: SonoAce 6000/Ultramark™ 400 Ultrasound System Device Name: Intra-Operative7.5MHz/40mm Linear Array Probe Transducer: erative romand imaging or fluid flow analysis of the human Indications for Use: body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | N | N | | | | | | N | Note 4 |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral - Vascular | | N | N | | | | | | N | Note 3 |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | N | N | | | | | | N | Note 3 |
| Muscular-Skeletal
Superficial | | N | N | | | | | | N | Note 3 |
| Others(Specify) | | | | | | | | | | |

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

Note 3: Includes imaging for guidance of biopsy

Note 4: Intra-Abdominal Organs

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Seymann

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Division Sign Off

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

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