ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER

K042326 · Ultrasonix Medical Corporation · IYN · Sep 16, 2004 · Radiology

Device Facts

• Record ID: K042326
• Device Name: ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
• Applicant: Ultrasonix Medical Corporation
• Product Code: IYN · Radiology
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac 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), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

Device Story

Mobile, software-controlled diagnostic ultrasound system; generates 2D, M-mode, Pulsed/CW Doppler, Color Flow, and Amplitude Doppler images. Inputs: ultrasound signals from linear, convex, microconvex, or phased array transducers; ECG signals via 3-lead assembly. Processing: piezoelectric transducer converts reflected sound waves to electrical signals; programmable beam-forming architecture uses reconfigurable building blocks for imaging modes. Outputs: real-time images, biometric measurements, audio Doppler, cine review, and DICOM storage. Used in clinics/hospitals by physicians to aid diagnosis/evaluation of soft tissues; supports biopsy, labeling, and image storage. Benefits: provides non-invasive anatomical and physiological assessment, aiding clinical decision-making through real-time visualization and quantitative analysis.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-37, and AIUM acoustic output standards. Acoustic output limits (ISPTA 720mW/cm2, MI 1.9) are consistent with Track 3 predicate devices. No clinical data required for this clearance.

Technological Characteristics

Piezoelectric transducer technology; 2-15MHz frequency range. Modes: 2D, M-mode, PW/CW Doppler, Color Flow, Power Doppler. Programmable beam-forming architecture using reconfigurable hardware blocks. Connectivity: DICOM module. Safety: IEC 60601-1, IEC 60601-2-37, AIUM standards. Biocompatible patient contact materials.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in obstetrics, gynecology, radiology, and cardiology. Patient population includes adults and pediatrics. Applications: abdominal, small parts, peripheral vascular, musculoskeletal, cephalic, breast, thyroid, testicle, transvaginal, transrectal, fetal, cardiac, transcranial, and transesophageal.

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

• Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630)
• ATL HDI 5000 System (K002003)
• Acuson Sequoia (K973767)

Submission Summary (Full Text)

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# SEP 1 6 2004 510 (k) Summary for the Ultrasonix Ergosonix 500 Ultrasound

This summary of safety and effectiveness is provided as part of this Premarket Notification in rnio Gammery 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

### 1.1 Submitter

Ultrasonix Medical Corporation 310-3480 Gilmore Way Burnaby, British Columbia Canada V5G 4Y1 (t) 604-437-9500 (f) 604-437-9502

### 1.2 Contact

lulia Nuca, Quality Assurance (t) 604-437-9500 x 112 (f) 604-437-9502 (e) [e-mail]

### 1.3 Date Prepared

August, 2004

### 2.0 Device Name

### 2.1 Common Name

Ultrasound Imaging System

### 2.2 Proprietary Name

Ergosonix Ultrasound Scanner Modulo 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 |

{1}------------------------------------------------

### 2.4 Classification

Class Ila

#### 2.5 Predicate Device:

Ultrasonix Ergosonix 500 Ultrasound Scanner (K020630) ATL HDI 5000 System (K002003) Acuson Sequoia (K973767)

### 2.6 Reason for submission:

# Clearance request for new transducers, new applications and a new mode

| Transducers: | Applications: |
|--------------|----------------|
| PA4-2 | cardiac |
| PA3-2 | interventional |
| PA7-4 | intraoperative |
| L9-4 | transcranial |
| L12-5 | transesophagea |
| L12-5W | |
| C5-1 60 | |
| C5-1 40 | |
| ER7 | |
| EC9-5 | |
| MC7 | |
| C7-4 | |
| L15-8 | |
| T7-4 | |
| 3DEC9-5 | |
| 3DC5-1 | |
| CC5-1 | |
| IOT7-4 | |
| IOJ7-4 | |

lmaging mode:

CW Doppler

#### Name change request

"Ultrasonix Ergosonix 500 Ultrasound Scanner", changed to "Ergosonix Ultrasound Scanner"

### New product clearance

"MODULO Ultrasound Scanner"

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### 2.7 Device description

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

The Modulo Ultrasound Scanner is identical to the Ergosonix Ultrasound Scanner, except that it has a different, smaller, enclosure. The Modulo Ultrasound Scanner has the same software and hardware as the Ergosonix Ultrasound Scanner, except for logo displays.

These systems have an electrocardiography (ECG) display feature and support a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PA and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage

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

| Frequency Range | 2-15MHz |
|------------------|-------------------|
| Transducer types | Linear array |
| | Curved array |
| | Intracavity array |
| | Phased array |

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The Egosonix and Modulo Ultrasound Scanners are designed to comply with the following standards:

| EN 60601-1 | European Norm, Medical Electrical Equipment |
|----------------|--------------------------------------------------------------------------------------|
| UL 2601-1 | Underwriters Laboratories Standards, Medical<br>Electrical Equipment |
| C22-2 No 601-1 | Canadian Standards Association, Medical<br>Electrical Equipment |
| EM 60601-1-1-2 | European Norm, Collateral Standard,<br>Electromagnetic Compatibility |
| IEC 60601-2-37 | Particular requirements for the safety of<br>ultrasonic medical diagnostic equipment |
| AIUM | Acoustic Output Labeling Standard for Diagnostic<br>Ultrasound Equipment - Jan 1998 |
| AIUM | Standard for Real-Time Display of Thermal and<br>Mechanical Acoustic Output Indices |

### 3.0 Summary of Intended Uses

The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac 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), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

### 4.0 Comparison to Predicate Device

The Ergosonix and Modulo Ultrasound Scanners are substantially equivalent to the predicate devices with respect to intended use/indications for use, principles of operation and technological characteristics.

### 5.0 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 sounds 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 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 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.

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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.

#### 6.0 Safety considerations

As track 3 ultrasound devices, the Ergosonix and Modulo Ultrasound Scanners are 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 Ergosonix and Modulo Ultrasound Scanners comply with the guideline limits set in the September 30, 1997 revision of 510(k) Diagnostic Ultrasound Guidance.

With regard to general safety, the Ergosonix and Modulo Ultrasound Scanners are 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 devices' 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 - 700W/cm2 (Range) |

The limits are the same as predicate Track 3 devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms extending upwards, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### SEP 1 6 2004

Ms. Iulia Nuca Quality Assurance Ultrasonix Medical Corp. 310-3480 Gilmore Way Burnaby, BC, V5G 4YI . . CANADA

Re: K042326

Trade Name: Ergosonix / Modulo Ultrasound Scanners 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 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic trasducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: August 25, 2004 Received: August 27, 2004

Dear Ms. Nuca:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bour 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 I edelul I ood, Drog, and sions of the Act. The general controls provisions of the Act include the general connents provision, 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 Ergosonix / Modulo Ultrasound Scanners, as described in your premarket notification:

Transducer Model Number

C5-1 40 convex 1/5MHz 40mm radius transducer C5-1 60 convex 1/5MHz 60mm radius transducer

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L12-5 linear 5/12MHz 38mm transducer L12-5W linear 5/12MHz 50mm transducer L9-4 linear 4/9MHz 38mm transducer PA3-2 phased array 2/3MHz transducer PA4-2 phased array 2/4MHz transducer PA3-2 phased array 2/4MHz transducer . PA7-4 phased array 4/7MHz transducer ER7 biplane endocavity 5/9MHz transducer EC9-5microconvex endocavity 5/9MHz 10mm radius transducer MC7 microconvex 5/9MHz 10mm radius transducer L15-8 linear 8/15MHz 29mm transducer C7-4 convex 4/7MHz 40mm radius transducer CC5-1 microconvex 1/5MHz 15mm radius transducer T7-4 TEE phased 4/7MHz transducer 3DC5-1 motorized convex 1/5MHz 40mm radius transducer 3DEC9-5 motorized microconvex 5/9MHz 10mm radius transducer IOT7-4 convex 4/7MHz 40mm radius intraoperational transducer IOJ7-4 linear 4/7MHz 38mm radius intraoperational transducer

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 it may or below 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 or uny 1 vith 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 Or N Fat 80 77 tucemes (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:

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Page 3 - Ms. Nuca

Enclosure(s)

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 noutication. The I 27 Imaling of succion 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 rryou destre specific at [phone]. Additionally, for questions on the contact the Office of Compilanour device, please contact the Office of Compliance at (301) 594promonon and advertising or Joulation entitled, "Misbranding by reference to premarket 4059. Also, please now the regaral information on your responsibilities under the houthcation (21 Orient and overy) ion 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".

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

Sincerely yours,

David R. Segerson

Nancy C. Brogdon

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

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Prescription Use (Per 221 CFR 801.109)

# Ergosonix Ultrasound Scanner Diagnostic Ultrasound Indications for Use Form

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 | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Abdominal | | P | P | P | N | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative Neurological | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Pediatric | | P | P | P | N | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transrectal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transvaginal | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | P (*1) | P (*2) |
| MSK Conventional | | P | P | P | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | P | P | P | P (*1) | P (*2) |
| Other (specify) (*3) | | N | N | N | | N | N | N | N (*1) | N (*2) |

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

### Additional Comments:

- 'r B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFMCWD, B/CFMCWD, B/DPD/CWD
B/WD, B/C/WD, B/CFM/PWD, B/AD/PWD, B/CFMCND, B/CF/C/P/D/
- 1 BIM, BIPWD, B/OVD, B/OHD, B/O/ M/X WB, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF WEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# MODULO Ultrasound Scanner

# Diagnostic Ultrasound Indications for Use Form

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 | | P | P | P | | P | P | P | P (*1) | P (*2) | |
| Abdominal | | P | P | P | | N | P | P | P | P (*1) | P (*2) |
| Intraoperative (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Intraoperative Neurological | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Pediatric | | P | P | P | | N | P | P | P | P (*1) | P (*2) |
| Small Organ (specify) | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Neonatal Cephalic | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Adult Cephalic | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Cardiac | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Transesophageal | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Transrectal | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Transvaginal | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Leparoscopic | | | | | | | | | | | |
| MSK Conventional | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| MSK Superficial | | P | P | P | | | P | P | P | P (*1) | P (*2) |
| Other (specify) (*3) | | N | N | N | | | N | N | N | N (*1) | N (*2) |

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

#### Additional Comments:

- 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/D/PWD, B/DPD/PWD, B/CFM/CWD, B/D/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

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

Concurrence of CDRH, Office of Device Evaluation (Division of General

510(k) Nu

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# C5-1 40 convex 1/5MHz 40mm radius transducer Diagnostic Ultrasound Indications for Use Form

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 | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Other (specify) | | | | | | | | | | |

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

#### Additional Comments:

*1 BIM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ØDE)

ion (ODE)
David A. Seymour

vision Sian-Off Division of Reproduc and Radiological De

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| C5-1 60 convex 1/5MHz 60mm radius transducer |
|----------------------------------------------|
|----------------------------------------------|

Diagnostic Ultrasound Indications for Use Form

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 | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Leparoscopic | | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) | |
| Other (specify) | | | | | | | | | | | |

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

#### Additional Comments:

*1 BM, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalue

Evaluation (ODE)
Daniel A. Symm

and 1 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 /

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# L12-5 linear 5/12MHz 38mm transducer

# Diagnostic Ultrasound Indications for Use Form

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 | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Other (specify) | | | | | | | | | | |

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

#### Additional Comments:

"1 BM, B/PWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluati

uation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042326

{13}------------------------------------------------

# L12-5W linear 5/12MHz 50mm transducer

# Diagnostic Ultrasound Indications for Use Form

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 | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Other (specify) | | | | | | | | | | |

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

#### Additional Comments:

*1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evalua

David h. Seymm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042326
510(k) Number

{14}------------------------------------------------

## L9-4 linear 4/9MHz 38mm transducer

### Diagnostic Ultrasound Indications for Use Form

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 | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | N | N | N | | N | N | N | N (*1) | N (*2) |
| MSK Superficial | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Other (specify) | | | | | | | | | | |

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

#### Additional Comments:

B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD ﮩ

- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

ion(ODE)
David R. Syverson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K042326
510(k) Number

{15}------------------------------------------------

# PA3-2 phased array 2/3MHz transducer Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | N | N | N | N | N | N | N | N (*1) | N (*2) |

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

#### Additional Comments:

^1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

uation (ODE)
David A. Sypm
Division Sign Off

(Division Sign-O Division of Reproducti and Radiological Dev E 1 011-1 11,

{16}------------------------------------------------

# PA4-2 phased array 2/4MHz transducer

# Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | N | N | N | N | N | N | N | N (*1) | N (*2) |

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

#### Additional Comments:

- B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD, B/DPD/CWD 、
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

valuation (ODE)
David R. Segerson
(Division Sign-Off)

Division of Reproductive, and Radiological Devic

{17}------------------------------------------------

# PA3-2 phased array 2/4MHz transducer

## Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | N | N | N | | N | N | N | N (*1) | N (*2) |

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

#### Additional Comments:

- B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD で
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (

David R. Lysem

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

{18}------------------------------------------------

Prescription Use (Per 221 CFR 801.109)

# PA7-4 phased array 4/7MHz transducer Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Adult Cephalic | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Cardiac | | N | N | N | N | N | N | N | N (*1) | N (*2) |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | N | N | N | | N | N | N | N (*1) | N (*2) |

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

#### Additional Comments:

- 1 B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- *2 Freehand 3D imaging, Directional Power Doppler (DPD)
- *3 Transcranial Doppler

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation {

tion (QDE)

(Division Sign-Off)

(Division Sign-Off, Division of Reproductive, and Radiological Devices

{19}------------------------------------------------

# ER7 biplane endocavity 5/9MHz transducer Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transvaginal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Leparoscopic | | | | | | | | | | |
| MSK Conventional | | | | | | | | | | |
| MSK Superficial | | | | | | | | | | |
| Other (specify) (*3) | | | | | | | | | | |

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

#### Additional Comments:

*1 B/M, B/PWD, B/C/ND, B/CFM/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD

*2 Freehand 3D imaging, Directional Power Doppler (DPD)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lygass

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

inal

{20}------------------------------------------------

# EC9-5 microconvex endocavity 5/9MHz 10mm radius transducer Diagnostic Ultrasound Indications for Use Form

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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transvaginal | | N | N | N | | N | N | N | N (*1) | N (*2) |
| Transurethral | | | | | |…