EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM

K101455 · Medison Co., Ltd. · IYN · Jul 19, 2010 · Radiology

Device Facts

• Record ID: K101455
• Device Name: EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

Device Story

EKO 7 is a mobile, software-controlled diagnostic ultrasound system for cardiac and general imaging. It acquires ultrasound data via transducers and displays it in B-mode, M-mode, color/power Doppler, harmonic imaging, and PW/CW spectral Doppler. The system allows operators to perform anatomical measurements and analysis. It features real-time acoustic output display (mechanical and thermal indices). Used by healthcare professionals in clinical settings to assist in diagnosis through visualization of structures and fluid flow. Output is viewed on-screen to inform clinical decision-making and patient management.

Clinical Evidence

Bench testing only. The device complies with safety standards including UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, IEC 61157, and ISO 10993-1. No clinical data was required for this 510(k) submission.

Technological Characteristics

Mobile ultrasound system; supports B, M, PW/CW Doppler, Color/Power Doppler, and Harmonic imaging. Biocompatible materials per ISO 10993-1. Connectivity includes real-time acoustic output display. Software-controlled. Complies with NEMA UD-2/UD-3 for acoustic output and IEC 60601-2-37 for diagnostic ultrasound safety.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-esophageal, musculoskeletal, cardiac, and peripheral vessel applications. Used in adult, pediatric, and neonatal populations.

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

• ACCUVIX V20 Diagnostic Ultrasound System (K092159)
• ACCUVIX V10 Diagnostic Ultrasound System (K093849)
• GE Vivid 3 Expert/Pro Diagnostic Ultrasound System (K020789)

Submission Summary (Full Text)

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

K101455

510(k) Premarket Notification

### 19 2010

EKO 7 Diagnostic Ultrasound System

### 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.

#### 1. Submitter's Information: 21 CFR 807.92(a)(1)

MEDISON CO., LTD. 1003, Daechi-dong, Gangnam-gu, Seoul 135-280, Korea

Contact Person: Mr. Kyung-Am, Shim Regulatory Affairs Manager

| Telephone: | 82.2.2194.1381 |
|------------|--------------------|
| Facsimile: | 82.2.2194.1399 |
| Email: | [e-mail] |

Data Prepared: March 25, 2010

#### 2. Name of the device:

Common/Usual Name:

Diagnostic Ultrasound System and Accessories

Proprietary Name:

EKO 7 Diagnostic Ultrasound System

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

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

K092159, ACCUVIX V20 Diagnostic Ultrasound System K093849, ACCUVIX V10 Diagnostic Ultrasound System K020789, GE Vivid 3 Expert/Pro Diagnostic Ultrasound System

510(k) Summary / Statement Certification

ATTACHMENT 1

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

#### 4. Device Description:

The EKO 7 is a dedicated cardiac purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, color Doppler imaging, power Doppler imaging, Harmonic imaging, PW spectral Doppler mode, CW spectral Doppler mode or as a combination of these modes. The EKO 7 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The EKO 7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The EKO 7 has been designed to meet the following product safety standards:

- UL 60601-1, Safety requirements for Medical Equipment
- CSA C22.2 No. 601.1, Safety requirements for Medical Equipment
- IEC60601-2-37, Diagnostic Ultrasound Safety Standards
- EN/IEC60601-1, Safety requirements for Medical Equipment
- EN/IEC60601-1-2, EMC requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 61157, Declaration of the acoustic output
- ISO10993-1, Biocompatibility

#### છે. Intended Uses:

The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional. superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

#### Technological Characteristics: 6.

The EKO 7 is substantially equivalent to the ACCUVIX V20 Diagnostic Ultrasound System, cleared via K092159, and the ACCUVIX V10 Diagnostic Ultrasound System, cleared via K094623. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

#### END of 510(K) Summary

510(k) Summary / Statement Certification

ATTACHMENT 1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the left. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## JUL 1 9 2010

Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K101455

Trade/Device Name: EKO 7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 23, 2010 Received: June 24, 2010

Dear Mr. Job:

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 EKO 7 Diagnostic Ultrasound System, as described in your premarket notification:

#### Transducer Model Number

| C1-4EC | P2-4BA |
|---------|--------|
| C2-6IC | P3-8CA |
| L3-8 | P4-12 |
| L5-13IS | CW2.0 |
| MPT3-7 | CW4.0 |

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de 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. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely vours, -

Mahal D.O.K. Kim

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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## Indications for Use

510(k) Number (if known):

Device Name: EKO 7 Diagnostic Ultrasound System

Indications for Use:

The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric and Peripheral-vessel.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR .

· Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Michael P. O'Keefe

Page 1 of 12

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101455

Indications For Use

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#### 510(k) No.:

## Device Name: EKO 7 Diagnostic Ultrasound System

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|--------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| (Track I only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | N | N | Note 1 | Notes 4, 7 |
| | Abdominal | N | N | N | N | N | Note 1 | Notes 4, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4,7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 1 | Note 7 |
| | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4,7 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4,7 |
| | Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 | Note 7 |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 5,6,7,9 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

510K

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety.

16-1545

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Section 1.3, Page 3

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

#### 510(k) No.:

Device Name: C1-4EC for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | P | P | P | P | P | Note 1 | Notes 7 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 7 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K060087; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

510F

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Nihil D'K
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

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

#### 510(k) No.:

# Device Name: C2-6IC for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | P | P | P | P | P | Note 1 | Notes 7 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | |
| &<br>Other | Pediatric | P | P | P | | P | Note 1 | Notes 7 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

ation and Safety


(Division Sign-Off)

Indications For Use

Office of In Vitro Diagnostic Device Evaluation and Sa
510K K101455

Division of Radiological Devices

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

#### 510(k) No.:

### Device Name: L3-8 for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Note 5, 6, 7, 9 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 5, 6, 7, 9 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 5, 6, 7, 9 |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 5, 6, 7, 9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | Note 1 | Note 5, 6, 7, 9 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Indications For Use

Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K101455

Division of Radiological Devices

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

#### 510(k) No.:

## Device Name: L5-13IS for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 5, 6, 7, 9 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 5, 6, 7, 9 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 5, 6, 7, 9 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 5, 6, 7, 9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 5, 6, 7, 9 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices

Indications For Use

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K101455

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

#### 510(k) No.:

# Device Name: MPT3-7 for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|----------------------|------------------------------|---------------------------------------------------|----|-----|-----|----------|-----------|---------|--|
| General | Specific | B | M | PWD | CWD | Color | Combined* | Other | |
| (Track I only) | (Tracks I & III) | | | | | Doppler* | (Spec.) | (Spec.) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging | Laparoscopic | | | | | | | | |
| &<br>Other | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | N | N | N | | N | Note 1 | Note 7 | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | ﻤﺴ | | | | | | |
| | Cardiac Adult | | 1 | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | N | N | N | | N | Note 1 | Note 7 | |
| | Other (spec.) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (spec.) | | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

*(Division Sign-Off)*

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Indications For Use

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

#### 510(k) No.:

# Device Name: P2-4BA for use with EKO 7

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

| Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------|--|
| 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 (See Note 3) | | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

510k

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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

#### 510(k) No.:

## Device Name: P3-8CA for use with EKO 7

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

| | Clinical Application | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | | | | | | | |
| | Abdominal | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging & Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

510k

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

Michael D. Kirk

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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

510(k) No.:

Device Name: P4-12 for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|
| 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 (See Note 3) | | | | | | | |
| | Abdominal | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Indications For Use

510K K101455

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

510(k) No.:

# Device Name: CW2.0 for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|---------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| 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 (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | P | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | | |
| | Cardiac Pediatric | | | | P | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices

Indications For Use

Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101455

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

Section 1.3, Page 12

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

## Device Name: CW4.0 for use with EKO 7

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

| Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |
|-----------------------------|------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------|--|
| 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>&<br>Other | Fetal (See Note 3) | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | P | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared under K092159; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+C+PW, B+PD+PW, B+C+CW, B+PD+CW, B+C+M, Dual B, Dual B+C, Dual B+PD

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI) / Pulse Inversion Harmonic Imaging

Note 8: 3D imaging

Note 9: Panoramic imaging

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)

***(Division Sign-Off)***

Indications For Use

Division of Radiological Devices tion and Safety Office of Ir