SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM

K994096 · Sonosite,Inc. · IYN · Dec 20, 1999 · Radiology

Device Facts

• Record ID: K994096
• Device Name: SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYN · Radiology
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Small Organs (breast, thyroid, testicle), Musculo-skeletal (conventional), Abdominal, Neonatal Cephalic, Cardiac (adult and pediatric), Intraoperative (abdominal organs and vascular), Trans-Rectal, Peripheral Vessel, Pediatric, Trans-vaginal.

Device Story

SonoHeart is a portable, software-controlled diagnostic ultrasound system. It uses piezoelectric transducers to transmit ultrasound energy into the body and receive reflected signals. The system processes these signals to generate 2D, Color Power Doppler, and PowerMap™ Directional Color Power Doppler images. It is operated by clinicians in various clinical settings to visualize anatomical structures, assess blood flow, and perform measurements for diagnostic purposes. The system provides on-screen thermal and mechanical acoustic output indices to assist users in adhering to ALARA principles. Output is displayed on an integrated monitor, aiding in clinical decision-making for disease assessment, procedural guidance (e.g., pericardiocentesis), and fetal monitoring. The device benefits patients by providing real-time, point-of-care diagnostic imaging.

Clinical Evidence

Bench testing only. The device complies with recognized standards including EN 60601-1, IEC 61000 series, ISO 10993 (biocompatibility), and AIUM/NEMA acoustic output standards. No clinical trial data was required for this 510(k) clearance.

Technological Characteristics

Piezoelectric transducer technology; 2.0-7.0 MHz frequency range; linear and curved array transducers. Modes: 2D, Color Power Doppler, PowerMap™ Directional Color Power Doppler. Compliance: EN 60601-1, IEC 61000-4, ISO 10993, AIUM/NEMA UD2-1998. Acoustic output: MI 1.9 max, ISPTA 720 mW/cm² max. Software-controlled image processing.

Indications for Use

Indicated for adult and pediatric patients for diagnostic ultrasound imaging and fluid flow analysis of the abdomen, small parts (breast, thyroid, testicle, abdominal wall), pediatric organs/superficial structures/hips, cardiac structures, female reproductive system, obstetrics (including high-risk pregnancies), and prostate. Used for disease assessment, injury evaluation, monitoring, and procedural guidance.

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

• Toshiba PowerVision 6000 (K991710)
• General Electric LOGIQ 500 MD (K991611)
• SonoSite 180 Hand-Carried Ultrasound System (K990806)
• SonoSite 180 Hand-Carried Ultrasound System (K981505)

Submission Summary (Full Text)

{0}------------------------------------------------

# DEC 2 0 1999

# 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)

Michael A. Hoffman Director - Regulatory Affairs and Quality Systems SonoSite, Inc. 19807 North Creek Parkway, Suite 200 Bothell, WA 98011-8214 (425) 951 - 1297 E-mail: [e-mail]

Date prepared: November 3, 1999

### Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:

Common/ Usual Name

Diagnostic Ultrasound System with Accessories

## Proprietary Name

SonoHeart™ Hand-Carried Echocardiography System (subject to change)

## Classification Names

| | 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 |

#### Identification of the predicate or legally marketed device: 3)

SonoSite, Inc. believes that SonoHeart™ Hand-Carried Echocardiography System is substantially equivalent to the currently

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

marketed Toshiba PowerVision 6000 (K991710), and the General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K990806 and K981505).

#### Device Description: 4)

The SonoHeart™ Hand-Carried Echocardiography System is a general purpose, highly portable, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, Color Power Doppler, and 2D PowerMap™ Directional Color Power Doppler or in a combination of modes. The SonoHeart™ Hand-Carried Echocardiography System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.

The SonoHeart™ Hand-Carried Echocardiography System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

| Frequency Range: | 2.0 - 7.0 MHz |
|-------------------|---------------------|
| Transducer Types: | Linear array |
| | Curved linear array |

The SonoHeart™ Hand-Carried Echocardiography System is designed to comply with the standards listed below.

| EN 60601-1:1997 | IEC 61000-4-4:1995 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| CAN/CSA C22.2, No. 601.1:1998 | IEC 61000-4-5:1999 |
| UL 2601-1:1999 | CISPR11:97 |
| EN 60601-1-2:1998 | ISO 10993 |
| CEI/IEC 61157:1992 | 21 CFR 820 |
| IEC 61000-4-2:1999 | ISO 9002 |
| IEC 61000-4-3:1997 | EN 46002 |
| Standard for Real-Time Display of<br>Thermal and Mechanical Acoustic Output<br>Indices on Diagnostic Ultrasound<br>Equipment, American Institute of<br>Ultrasound in Medicine, 1998 | Acoustic Output Measurement and<br>Labeling Standard for Diagnostic<br>Ultrasound Equipment, American<br>Institute of Ultrasound in Medicine,<br>1993 |
| Acoustic Output Measurement Standard<br>for Diagnostic Ultrasound Equipment,<br>NEMA UD2-1998 | European Active Medical Device<br>Directive (93/42/EEC)<br>Japanese National Standard, JIS-T-<br>100x series |

{2}------------------------------------------------

#### 5) Intended Use:

The SonoHeart™ Hand-Carried Echocardiography System intended uses as defined FDA quidance documents are:

| Fetal - OB/GYN | Small Organs (breast,<br>thyroid, testicle) | Musculo-skeletal<br>(conventional) |
|------------------------------------------------------|---------------------------------------------|------------------------------------|
| Abdominal | Neonatal Cephalic | Cardiac (adult and<br>pediatric) |
| Intraoperative<br>(abdominal organs and<br>vascular) | Trans-Rectal | Peripheral Vessel |
| Pediatric | Trans-vaginal | |

Typical examinations performed using SonoHeart™ Hand-Carried Echocardiography System are:

Abdomen: This system transmits ultrasound energy into the upper and lower quadrants of the abdomen of an adult or pediatric patient to obtain 2D or Color Power Doppler images, or PowerMap™ Directional Color Power Doppler which can be used to assess the presence and extent of disease and injury.

Study of small parts and superficial structures including breasts, shoulders. thvroid, and the abdominal wall: This system transmits ultrasound energy into the superficial soft tissue structures of body to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of normal structure and pathology of the breast, thyroid abdominal wall, shoulders, wrist, ankle and knee.

Pediatric scans of organs, superficial structures, and bony structures: This system transmits ultrasound energy into the abdomen, pelvis and superficial structures of pediatric patients to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the abdominal organs, great vessels, pelvic structures and pediatric hips.

General cardiac studies in adults and pediatrics: This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the heart, great vessels, and jusxtaposed anatomic and pathologic structures. This can be used to assess overall cardiac performance and size, determine the presence and size of fluid around the heart and lungs, and as an aid in certain procedures (namely pericardialcentesis, and pleuralcentesis).

GYN/Infertility: This system transmits ultrasound energy into the lower abdomen or vagina of a female patient to obtain 2D or Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the reproductive system. which can be used to assess the presence and

{3}------------------------------------------------

extent of disease in the female pelvic organs, monitor ovarian follicle size, and as an aid in CVS procedures.

Obstetrics: This system transmits ultrasound energy into the abdomen or vagina of a pregnant woman to obtain 2D images of a fetus, which can be used to estimate gestational age, number and weight, and assess the presence and extent of disease and confirm viability. Color Power Doppler or PowerMap™ Directional Color Power Doppler imaging is intended for high-risk pregnant women. High risk pregnancy indications include, but are not limited to multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.

Prostate: This system transmits ultrasound energy through the prostate of an adult patient to obtain 2D or Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of structures, which can be used to assess the presence and extent of disease or injury.

#### 6) Technological Characteristics:

This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, Color Power Doppler, and PowerMap™ Directional Color Power Doppler) are the same as predicate devices identified in item 3. Transducer patient contact materials are biocompatible.

This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1998) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

720 mW/cm² (Maximum) ISPTAd TIS/TIB/TIC 0.1 - 4.0 (Range) Mechanical Index (MI) 1.9 (Maximum)

All Applications:

{4}------------------------------------------------

| ISPPAd | 0 - 700 W/cm2 (Range) |
|--------|-----------------------|
|--------|-----------------------|

The limits are same as predicate Track 3 devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem consisting of three stylized human profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

SonoSite, Inc. c/o Carole Stamp TUV Product Services, Inc. 175 Old Highway 8 NW New Brighton, MN 55112

K994096 Re: Trade Name: SonoHeart™ Hand-Carried Echocardiography System Requlatory Class: II Product Code: 90 IYN and 90 IYO 21 CFR 892.1550 and 1560 Dated: December 2, 1999 December 3, 1999 Received:

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 SonoHeart™ Hand-Carried Echocardiography System, as described in your premarket notification:

> Transducer Model Number ICT/7-4 7-4 MHz Intercavitary Transducer L7-4 MHz Linear Array C60/5-2 5-2 MHz Curved Array C15/402 MHz MCX Convex 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. H substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, the Food and Drug Administration (FDA) may requlatory action. publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{6}------------------------------------------------

Page 2 - Ms. Carole Stamp

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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). 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 Rod Perez at [phone].

Sincerely yours,

David A. Stegem

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

Enclosure (s)

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

K994096

# System: SonoHeart™ Hand-Carried Echocardiography System

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

| Clinical Application | | | | | | Mode of Operation | | | | |
|---------------------------|----------------------------------------------------|---|---|-----|-----|-------------------|---------------------|------------------|--|--|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | | | | B+M | Note 1 | | |
| | Abdominal | P | P | | | | B+M | Note 1 | | |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note 1 | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | | | | B+M | Note 1 | | |
| | Small Organ (breast,<br>thyroid, testicles.) | P | P | | | | B+M | Note 1 | | |
| | Neonatal Cephalic | P | P | | | | B+M | Note 1 | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | P | P | | | | B+M | Note 2 | | |
| | Trans-vaginal | P | P | | | | B+M | Note 1 | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | | | | B+M | Note 1 | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | | | | B+M | Note 1 | | |
| | Cardiac Pediatric | P | P | | | | B+M | Note 2 | | |
| | Trans-esophageal (card.) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | | | B+M | Note 1 | | |
| | Other (spec.) | | | | | | | | | |

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.

Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Prescription Use (Per 21 CFR 801.109)

Daniel A. Seymann

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

510(k) Number K944016

Indications For Use

Section 4.3, page 10

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

#### SonoHeart™ Hand-Carried Echocardiography System Svstem: Transducer: ICT/7-4 7-4 MHz Intracavitary Transducer

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | | | | B+M | Note 1 |
| | Abdominal | | | | | | | |
| | Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | | | | B+M | Note 2 |
| | Trans-vaginal | P | P | | | | B+M | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

### Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic lmaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.

Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Prescription Use (Per 21 CFR 801,109)

David k. Seym

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

510(k) Number K944096

{9}------------------------------------------------

### SonoHeart™ Hand-Carried Echocardiography System System: Transducer: L7-4 MHz Linear Array

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | | | | B+M | Note 1 |
| | Abdominal | P | P | | | | B+M | Note 1 |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note 1 |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | | | | B+M | Note 1 |
| | Small Organ (breast,<br>thyroid, testicles.) | P | P | | | | B+M | Note 1 |
| | Neonatal Cephalic | P | P | | | | B+M | Note 1 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | | | | B+M | Note 1 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | P | P | | | | B+M | Note 2 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | | | | B+M | Note 1 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.

Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Prescription Use (Per 21 CFR 801.109)

Vaind a. Seymm

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

510(k) Number K944096

{10}------------------------------------------------

#### SonoHeart™ Hand-Carried Echocardiography System System: Transducer: C60/5-2 5-2 MHz Curved Array

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

| Clinical Application | | Mode of Operation | | | | | | | | |
|--------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|--|--|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | |
| (Track I only) | (Tracks I & III) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | | | | B+M | Note 1 | | |
| | Abdominal | P | P | | | | B+M | Note 1 | | |
| | Intra-operative (Abdominal<br>organs and vascular) | P | P | | | | B+M | Note 1 | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | | | | B+M | Note 1 | | |
| | Small Organ (breast,<br>thyroid, testicles.) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | | |
| | Intra-luminal | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | | | | B+M | Note 1 | | |
| | Cardiac Pediatric | P | P | | | | B+M | Note 2 | | |
| | Trans-esophageal (card.) | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (spec.) | | | | | | | | | |

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

Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler. combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.

Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Jmaging, Harmonic Imaging, and imaging for guidance of biopsy.

Prescription Use (Per 21 CFR 801.109)

Ehrich A. Sezem

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

510(k) Number

{11}------------------------------------------------

### SonoHeart™ Hand-Carried Echocardiography System System: System: - Contract Convex Array

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

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|----------------------------------------------------|-------------------|---|-----|-----|------------------|---------------------|------------------|
| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | | | | B+M | Note 1 |
| | Abdominal | N | N | | | | B+M | Note 1 |
| | Intra-operative (Abdominal<br>organs and vascular) | N | N | | | | B+M | Note 1 |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | B+M | Note 1 |
| | Pediatric | N | N | | | | B+M | Note 1 |
| | Small Organ (breast,<br>thyroid, testicles.) | N | N | | | | B+M | Note 1 |
| | Neonatal Cephalic | N | N | | | | B+M | Note 1 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | | | | B+M | Note 1 |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | | | | B+M | Note 2 |
| | Cardiac Pediatric | N | N | | | | B+M | Note 2 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | | | | B+M | Note 1 |
| | Other (spec.) | | | | | | | |

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

### Additional Comments:

Additional Sommoner
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, Note 1: Other Includes Color Power Doppler, J-D Imaging, Harmonic combined B and PowelMap - Directional Octor Power Power Power Portuge of S10(k) K981505.

imaging, and Imaging Torgan Doppler, combined B and Color Power Doppler, Note 2. Other includes Oolor Fower Doppler, 3-D Imaging, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.

Prescription Use (Per 21 CFR 801.109)

David M. Symm
(Division Sign-Off)

(Division Sign-C (Division Sign-Ont)
Division of Reproductive, Abdominal, ENT, and Radiological 510(k) Number

Indications For Use

Section 4.3, page 14