ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER

K020630 · Ultrasonix Medical Corporation · IYN · Jun 13, 2002 · Radiology

Device Facts

• Record ID: K020630
• Device Name: ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
• Applicant: Ultrasonix Medical Corporation
• Product Code: IYN · Radiology
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), transvaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).

Device Story

The Ultrasonix Ergosonix 500 is a mobile, software-controlled diagnostic ultrasound system. It utilizes piezoelectric transducers to transmit ultrasound waves into the body and receive reflected echoes. The system processes these signals to generate 2D B-mode, M-mode, Pulsed Doppler, Color Flow, and Amplitude Doppler images. It supports real-time compound and harmonic imaging. Operated by physicians in clinical settings, the device aids in the diagnosis and evaluation of soft tissues. Output is displayed on the system monitor, allowing clinicians to perform biometric studies and assess anatomy and blood flow, facilitating clinical decision-making for various diagnostic applications.

Clinical Evidence

Bench testing only. The device complies with recognized safety and performance standards, including EN 60601-1, UL 2601-1, and AIUM acoustic output labeling standards. Acoustic output measurements (ISPTA, TIS/TIB/TIC, MI, ISPPA) were verified to be within the limits established for Track 3 ultrasound devices.

Technological Characteristics

Mobile ultrasound system with 2-15MHz frequency range. Supports linear, convex, and microconvex arrays. Piezoelectric sensing principle. Software-controlled beam forming architecture using two reconfigurable building blocks. Complies with IEC 60601-1, IEC 60601-2-37, and NEMA UD-3. Biocompatible patient-contact materials. Connectivity and specific software architecture details are not provided beyond general software-controlled operation.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including abdominal, small parts (thyroid, breast, testicle), peripheral vascular, musculoskeletal, cephalic, transvaginal, transrectal, pediatric, fetal, and cardiac applications. For use by qualified physicians.

Regulatory Classification

Identification

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

Predicate Devices

• ATL HDI 5000 System (K002003)
• Acuson Sequoia (K973767)

Submission Summary (Full Text)

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KO20630

# 510(k) Summary for the Ultrasonix Ergosonix 500 Ultrasound Scanner

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) Summary.

#### 1.0 Submitter Information

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

JUN 1 3 2002

#### 1.1 Submitter:

Ultrasonix Medical Corporation 535 - 2660 Oak Street Vancouver, British Columbia Canada. V6H 3Z1

#### Contact: 1.2

Ken Seto Quality Assurance / Regulatory Engineer [e-mail] (604) 875 — 4985

# Other Contact:

Laurent Pelissier Chief Technical Officer [e-mail] (604) 875 — 5295

#### 1.3 Date prepared:

February 20 2002

#### 2.0 Device Name

#### 2.1 Common Name:

Ultrasound Imaging System

#### 2.2 Proprietary name:

Ultrasonix Ergosonix 500 Ultrasound Scanner

#### 2.3 Classification Name:

| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

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#### Classification: 2.4

Class II

#### Predicate Device: 2.5

ATL HDI 5000 System (K002003) Acuson Sequoia (K973767)

#### 2.6 Reason for submission:

New product

#### 3.0 Device Description

The Ultrasonix Ergosonix 500 Ultrasound Diagnostic Scanner is highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images.

The system is designed for use in linear and convex scanning modes, and supports linear, convex, and microconvex probes.

| Frequency Range | 2-15MHz |
|------------------|-----------------------------------------------------|
| Transducer types | Linear array<br>Curved array<br>Intracavitary array |

The Ultrasonix Ergosonix 500 is designed to comply to the following standards:

·EN 60601-1: 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 ·EN 60601-1-2 : European Norm, Collateral Standard, Electromagnetic Compatibility • EC 60601-2-37: Particular requirements for the safety of ultrasonic medical diagnostic equipment ·AIUM "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment" Jan 1998 •AIUM "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices"

#### Summary of Intended Uses 4.0

The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), transvaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).

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#### Comparison to Predicate Device 5.0

The Ultrasonix Ergosonix 500 diagnostic ultrasound scanner is substantially equivalent to the predicate devices with respect to intended use / indications for use, principles of operation and technological characteristics.

#### 6.0 Technological Characteristics

The technological characteristics are substantially similar to that of the predicates. The device operates identically 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 2D or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler) are the same as a the predicate devices identified in item 2.5. Transducer patient contact materials are biocompatible.

The beam forming architecture is very similar to that of the predicate devices. The receiving and processing hardware is similar but more innovative in that it is a programmable system made of 2 building blocks, which can be reconfigured to operate the system in any imaging mode.

The parameters used to adjust image quality are the same as that seen in the predicates. This includes the use of TGC gain sliders, depth control, base control and angling, among others.

#### 7.0 Safety Considerations

As a track 3 ultrasound device, the Ultrasonix 500 Ultrasound Diagnostic Scanner is designed to comply with the 'Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD -3.

With respect to limits on acoustic outputs, the Ultrasonix 500 Ultrasound diagnostic scanner complies with the guideline limits set in the September 30, 1997, Revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Ultrasonix Ergosonix 500 Ultrasound diagnostic scanner is designed to comply with IEC 601-1(1988) Medical Electrical Equipment, Part 1: General Requirements for Safety, and IEC 60601 - 2-37: Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.

The device's acoustic output limits are:

| ISPTA (d) | 720mW/cm2 |
|-----------------------|---------------------|
| TIS/TIB/TIC | 0.1 - 4.0 (Range) |
| Mechanical Index (MI) | 1.9 (Maximum) |
| ISPPA (d) | 0-700 W/cm2 (Range) |

The limits are the same as predicate Track 3 devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

Mr. Ken Seto Ouality Assurance / Regulatory Engineer Ultrasonix Medical Corp. Jack Bell Research Centre 535 - 2660 Oak St. VANCOUVER BC CANADA V6H 3Z6

Re: K020630

Trade Name: Ultrasonix Ergosonix 500 Ultrasound Scanner Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: May 3, 2002 Received: May 10, 2002

Dear Mr. Seto:

We have reviewed your Section 510(k) premarket 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 Ultrasonix 500 Ultrasound Scanner, as described in your premarket notification:

Transducer Model Number

4C1 Transducer L7 Transducer EC6.5 / 128 Transducer

Image /page/3/Picture/12 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird with three human profiles incorporated into the design.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Part 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".

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Page 3 - Mr. Seto

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

Sincerely yours,

Daniel A. Dyson

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

Enclosure(s)

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The Ergosonix 500 System

### Diagnostic Ultrasound Indications for Use Form

### Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Application | A | B | િય | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify)<br>* |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | ﺗﻤﻜﻴﺔ ﺗﺴﻤﻴﺔ | | | ma are | | ﻟﻤﺤﺘﻮﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﻲ ﺍﻟﻤﺴﺘﻘﻠﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ | |
| Abdominal | | | | ﺗﺤﻘﻴﻘﺎ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | | | | | Support Fridge States Company Company Company Company Company Company Company Company Company Company Company Company Company Comments Comments Comments of Children Comments | ﻣﺴﺘﻌﻤﻞ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatnc | | | ﺗﻘﺮﻳﺒﺎ ﺗﻘﺮﻳﺒﺎ ﺗ | مڪندڙ آهن. | | | | | | |
| Small Organ (specify) | | | | ميٽرمٽ ميٽرمٽ | | ﻟﻤﻜﺘﺐ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | | ﻣﺘﻌﺪﺩ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | - 3 - 2 | |
| Neonatal Cephalic | | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | | مستمبر آهي. منتشمر آهي ته ا | | ممكنية تسمير المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى ا | | 1500 | Support September 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 19 | |
| Adult Cephalic | | | | 13 | | مقارم محمد معتقد معتقد معاشرة من المقارمة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المس | | ﻛﺮ ﻛﺮﺓ ﻛﺮ | The property | and the province of the proposition of the program and the program and the program and the production of the first and the first and the first and the first and the first and |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | سمحمد بلادة مستخدم من المستخدم المستخدم المستخدم المستخدم المستخدم المستخدم المستخدم المشاهدة المستخدم المستخدم المستخدم المستخدم المشاهدة المستخدم المستخدم المستخدم المستخدم | | | مستور آهي. وقترار آهي | | 13 | | 1 - 1 - 1 |
| Transvaginal | | | ﺗﺤﻤﻴﺮ ﺗﻜﺴﻜﺮﻳﻢ | | | ﻛﺘﻴﺮ ﺑﺎﺳﻢ ﺍﻟﻤﺴﺘﻮﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | | مجمعة من جميع المحمول المحمول المحمول المحمول المحمول المحمول المستمر المنتخب المحمول المستقل المستقل المحمول المستقل المحمول المستقل المحمول المستقل المحمول المستقل المحمول | | ్లాల్లో ప్రభావాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీలాల్లో విశ్రీల |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | 1 | ﮐﺴﺮ ﭘﺎﮐﺴﺘﺎ | سمحمد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع | | ್ಕೆ ಸ್ಟ್ರಾನ್ಸ್ ಸ್ಟ್ರೀಕ್ಷಿಸಿದ್ದ | ﻛﺘﻮﺑﺮ ﺃﻣﺮﻳﻜﺎ ﻓﻲ ﻣﺴﺘﻮﻯ ﺍﻟﺴﻴﺎﺭﺍﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ | مستقبرة ا | تحميرة ست | Separate " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | ﺷﻬﺪ ﻗﺮﻳﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | 1 | 135 | | ﻟﻘﺎﺑﺔ ﺍﻟﻤﺴﺘﻌﻤﻠﻬﺎ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ | Franch | ﺗﻘﺮﻳﺒﺔ ﻣﻦ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | "",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""",""" | |
| Musculo-skeletal Superficial | | - 335 | ﻳﺘﺮ ﺇﻟﻰ | ﺑﻜﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ | | تم سمي آهي. م | تحتيم په سان | Spany Super | Spanish | ﻣﻌﺘﻘﺪ ﺗﻢ ﺗﻌ |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

Small parts: thyroid, breast, testicles, etc ... I

*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD

*2: Compound Imaging (BX), Tissue harmonic imaging

Tissue Harmonic is an option in B mode, not an actual scanning mode.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Daniel A. Harper

(Division Sign-Off) Division of Reproductive, A and Radiological Device E-3 510(k) Numbe

{7}------------------------------------------------

# Ergosonix 500 and 4C1 Transducer

### Diagnostic Ultrasound Indications for Use Form

### Fill out one form for each ultrasound system and each 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | متمير آهي. متحدث ت | ﻟﻜﻤﻴﻨﻴﻮﻧﻴﺔ ﺍﻟﻤﺴﺘﻮﻳﺘﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | | ﻣﺘﻨﻴﺮ ﺗﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | Status Carana | Transal | April 2017 - 12:40 PM IST - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 1 | Transport |
| Abdominal | | ﺗﻜﺴﻬﺮ ﺗﻢ ﺗﻜﺮﻳﻢ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | محمدر الممثلات الممثلة الممثلة المستوى المستوى المستوى المستوى المستوى الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق | September 1998 | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | متعدد المتعدد المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى | مستقليم تحقيق تش | مڪمرٽ سم | | محمد محمد منهم الحمير من المحمد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال | ممتعدد المشكرية المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستو | مختلف المقتلم المقتلبة المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستو | 125555565688888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 | Article Property |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

*1: B&M, B&PWD, B&CD&PWD, B&CD, B&AD, B&AD&PWD

*2: Compound Imaging (BX), Tissue harmonic imaging

Tissue Harmonic imaging is an option in B mode, not an actual scanning mode.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Severson

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

F-3

{8}------------------------------------------------

# Ergosonix 500 and L7 Transducer

# Diagnostic Ultrasound Indications for Use Form

# Fill out one form for each ultrasound system and each transducer.

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

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----…