ULTRASOUND IMAGING SYSTEM, MODEL 7300

K040596 · Esaote, S.p.A. · IYN · Mar 31, 2004 · Radiology

Device Facts

• Record ID: K040596
• Device Name: ULTRASOUND IMAGING SYSTEM, MODEL 7300
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Mar 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's Model 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

Device Story

The 7300 is a compact, portable ultrasound system for diagnostic general imaging. It processes ultrasonic pulse-echo and Doppler signals from phased, convex, and linear array probes. Modes include B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). The system features an LCD color display, alphanumeric keyboard for patient data/annotations, and digital archival via CD-RW or LAN. Operated by clinicians in clinical settings, the device provides real-time images and measurements (cardiac, vascular, OB) to assist in diagnostic decision-making. Optional accessories include video recorders, printers, and a mobile trolley. The device benefits patients by providing non-invasive diagnostic visualization of internal structures and blood flow.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison, electrical safety testing (IEC60601-1), and acoustic output compliance (Track 3).

Technological Characteristics

Portable ultrasound system (10 kg). Probes: Phased, convex, linear arrays. Imaging modes: 2D, M-Mode, PW/CW Doppler, Color Flow, Amplitude Doppler, TEI. Frequencies: 2.0-10 MHz. Connectivity: LAN, CD-RW. Display: SVGA LCD. Safety: IEC60601-1, Track 3 acoustic output. Biopsy guidance supported.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small organ (Thyroid, Breast, Testicles), Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, and Pediatric examinations.

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

• Esaote 7250 Ultrasound Imaging System (K982444)
• Esaote 7250 Ultrasound Imaging System (K004360)
• Esaote 7250 Ultrasound Imaging System (K994369)
• Esaote Technos Ultrasound Imaging System (K014168)
• Philips Medical Systems M2540 Ultrasound System (K014199)

Submission Summary (Full Text)

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

KD.4 D596

510(k) Summary 7300 Ultrasound Imaging System Esaote, S.p.A.

# MAR 3 1 2004

# 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

#### 807.92(a)(1)

#### Submitter Information

Colleen Densmore, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: [phone] Facsimile: [phone]

| Contact Person: | Carri Graham | |
|-------------------------|----------------------------------------------------------------------------------------------------|---------|
| Date: | February 20, 2004 | |
| 807.92(a)(2) | | |
| Trade Name: | 7300 Ultrasound Imaging System | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 | |
| Classification Number: | 90IYN; 90IYO | |
| 807.92(a)(3) | Predicate Device(s) | |
| Esaote, S.p.A. | 7250 Ultrasound Imaging<br>System | K982444 |
| Esaote, S.p.A. | 7250 Ultrasound Imaging<br>System | K004360 |

| Esaote, S.p.A. | 7250 Ultrasound Imaging<br>System | K994369 |
|-------------------------|--------------------------------------|---------|
| Esaote, S.p.A. | Technos Ultrasound<br>Imaging System | K014168 |
| Philips Medical Systems | M2540 Ultrasound System | K014199 |

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

510(k) Summary 7300 Ultrasound Imaging System Esaole, S.p.A.

### 807.92 (a)(4)

## Device Description

The 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissuc Enhancement Imaging (TEI). The 7300 is equipped with an LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7300 can drive phased (PA), convex (CA) and linear array (1.A) probes. The 7300 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7300 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an isolation transformer.

#### 807.92(a)(5)

### Intended Use(s)

Esaote's Model 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.

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

510(k) Summary 7300 Ultrasound Imaging System
Esaote, S.p.A. 807.92(a)(6)

## Technological Characteristics

| | Technological Characteristics<br>7300 (This submission) | Megas (K982444 & 994369) |
|---------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|
| Electrical Safety | IEC60601-1 | IEC60601-1 |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Indication for Use | | |
| • Cardiac | YES | YES |
| • Transesophageal | YES | YES |
| • Peripheral Vascular | YES | YES |
| • Neonatal Cephalic | YES | YES |
| • Adult Cephalic | YES | YES |
| • Small organ | YES | YES |
| • Musculoskeletal (conventional<br>& superficial) | YES | NO |
| • Abdominal | YES | YES |
| • OB/Fetal | YES | YES |
| • Transvaginal | YES | YES |
| • Transrectal | YES | YES |
| • Pediatric | YES | YES |
| Probe Technology | | |
| • Annular Array | NO | YES |
| • Phased Array | YES | YES |
| • Linear array | YES | YES |
| • Convex Array | YES | YES |
| Modes of operation | 2D, M-Mode, PW, CW, CFM,<br>Amplitude Doppler, TEI | 2D, M-Mode, PW, CW, CFM,<br>Amplitude Doppler, TEI |
| Imaging Frequencies | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz | 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0 MHz | 2.0, 2.5, 3.3, 5.0 MHz |
| Tissue Velocity Mapping feature | YES | NO |
| Biopsy Guidance | YES | YES |
| • Biopsy Intended Uses | General Purpose, Transrectal,<br>Transvaginal | General Purpose, Transrectal,<br>Transvaginal |
| • Biopsy Line Depth marker | 1 cm | 1 cm |
| Needle Guide Angle | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8° | ABS421: 20° 30°<br>ABS523: 45°<br>ABS123: 3.8° |
| Display Type | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES |
| DICOM Classes: | YES | YES |
| Media Storage, Storage SCU | | |
| VCR / Page Printer | YES | YES |
| M&A Capabilities | Cardiac, Vascular, OB and general<br>purpose measurements | Cardiac, Vascular, OB and general<br>purpose measurements |
| Weight | 10 kg | 25 kg |
| Dimensions | portable position:<br>35.5 (w) x 14 (h) x 49 (d) cm<br>use position: | portable position:<br>46 (w) x 23.5 (h) x 55 (d) cm<br>use position: |
| | 35.5 (w) x 41 (h) x 49 (d) cm | 46 (w) x 23.5 (h) x 68 (d) cm |

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2004

Esaote, S.p.A. % Ms. Carri Graham The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K040596

Trade Name: 7300 Ultrasound Imaging System 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 transducer Regulatory Class: II Product Code: 90 IYN, IYO. and ITX Dated: March 5, 2004 Received: March 8, 2004

#### Dear Ms. Graham:

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 7300 Ultrasound Imaging System, as described in your premarket notification:

#### Transducer Model Number

| PA230E |
|--------|
| PA122E |
| LA523 |
| CA421 |

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

## EC123 TE022

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".

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

Page 3 – Ms. Graham

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

Sincerely yours,

David A. Lygum

for

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

Enclosures

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

#### Mod.7300

## 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 (specify)<br>TEI (3) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N [2] | N |
| Abdominal | | N | N | N | | N | N | | N [2] | N |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | N [2] | N |
| Small Organ (specify) [1] | | N | N | N | N | N | N | | N [2] | |
| Neonatal Cephalic | | N | N | N | N | N | N | | N [2] | |
| Adult Cephalic | | N | N | N | N | N | N | | N [2] | |
| Cardiac | | N | N | N | N | N | N | | N [2] | N |
| Transesophageal | | N | N | N | N | N | | | N [2] | |
| Transrectal | | N | N | N | | N | N | | N [2] | |
| Transvaginal | | N | N | N | | N | N | | N [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | N | N | N | | N [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | N | N | N | | N [2] | |
| Musculo-skeletal Superficial | | N | N | N | N | N | N | | N [2] | |
| Other (specify) | | | | | | | | | | |

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

[1] Small organs include Thyroid, Breast and Testicles.

- [2] Applicable combined modes: B+M+PW+CW+CFM+PD
- [3] Tissue Enhancement Imaging (TEI)

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lymm

510k)

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

#### Transducer: PA230E

| 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 (specify)<br>TEI (2) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | N | N | N | N | | N[1] | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | | N[1] | |
| Cardiac | N | N | N | N | N | N | N | | N[1] | N |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

[1] Applicable combined modes: B+M+PW+CW+CFM+PD

[2] Tissue Enhancement Imaging (TEI)

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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

#### Transducer: PA122E

| 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 (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | N | N | N | | N[1] | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | N | N | N | N | N | | N[1] | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | N[1] | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | N | N | N | | N[1] | |
| 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] Applicable combined modes: B+M+PW+CW+CFM+PD

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

concurrence of CDRH. Office of Device Evaluation (ODE)

David Oh. Lyman

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

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

#### Transducer: LA523

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

| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N[2] | |
| Small Organ (specify) [1] | | N | N | N | | N | N | | N[2] | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N[2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | | N | N | | N[2] | |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N[2] | |
| Other (specify) | | | | | | | | | | |

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

[1] Small organs include Thyroid, Breast and Testicles.

{2} Applicable combined modes: B+M+PW+CW+CFM+PD

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Byrom

---

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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

### Transducer: CA421

| | | 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 (specify)<br>TEI (2) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N[1] | N |
| Abdominal | | N | N | N | | N | N | | N[1] | N |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N[1] | N |
| 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) | | | | | | | | | | |

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

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

[1] Applicable combined modes: B+M+PW+CFM+PD.

[2] Tissue Enhancement Imaging (TEI)

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David bh. Sezman

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

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

#### Transducer: EC123

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 (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[1] | |
| Transvaginal | | N | N | N | | N | N | | N[1] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

[1] Applicable combined modes: B+M+PW+CFM+PD.

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

(Division S gn-Off) Division of Reproductive, Abdominal. and Radiological Dev

510(k) Number K040596

{12}------------------------------------------------

#### Transducer: TE022

| | 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 (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | N | N | N | N | | | N[1] | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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

{ l ] Applicable combined modes: B+M+PW++CW+CFM+PD

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

concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lawson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.