UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM

K130803 · Samsung Medison Co., Ltd. · IYN · Apr 12, 2013 · Radiology

Device Facts

• Record ID: K130803
• Device Name: UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Apr 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The UGEO H70c 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 Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Story

UGEO H70c is a software-controlled, hand-held diagnostic ultrasound system. It acquires ultrasound data via transducers and displays images in B-mode, M-mode, Color/Power Doppler (S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. Operated by healthcare professionals in clinical settings. The system provides real-time acoustic output display (mechanical and thermal indices). Operators use the system to measure anatomical structures and perform analysis to assist in clinical diagnosis. Benefits include non-invasive visualization of internal structures and fluid flow, aiding in diagnostic decision-making and biopsy guidance.

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, and ISO 10993-1 for biocompatibility. No clinical data was required for this 510(k) submission.

Technological Characteristics

General purpose ultrasound system; supports multiple transducer types (e.g., SC1-6, L4-7, P3-8). Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Elastoscan. Safety compliance: IEC 60601-2-37, NEMA UD-2, NEMA UD-3. Biocompatibility: ISO 10993-1. Software-controlled architecture.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Used for patients of all ages, including neonates, pediatric, and adults.

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 A30 Diagnostic Ultrasound System (K112339)
• UGEO G60 Diagnostic Ultrasound System (K122583)
• MySono U6 Diagnostic Ultrasound System (K113381)

Submission Summary (Full Text)

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K/30803
Page 1 of 2

1 2 2013

510(k) Premarket Notification UGEO H70c 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)

SAMSUNGMEDISON CO., LTD. 42. Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person: Kyeong-Mi, Park Regulatory Affairs Manager

| Telephone: | 82.2.2194.1373 |
|------------|----------------|
| Facsimile: | 82.2.554.7567 |

## Data Prepared: November 15, 2012

### 2. Name of the device:

| Common/Usual Name: | | |
|----------------------------------------------|-----------|--------------|
| Diagnostic Ultrasound System and Accessories | | |
| Proprietary Name: | | |
| UGEO H70c 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:

- ACCUVIX A30 Diagnostic Ultrasound System(K112339) .
- UGEO G60 Diagnostic Ultrasound System (K122583) -
- MySono U6 Diagnostic Ultrasound System(K113381) .

### ATTACHEMENT I

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K130803
Page 2 of 2

UGEO H70c Diagnostic Ultrasound System 510(k) Premarket Notification

### 4. Device Description:

The UGEO H70c is a general purpose, hand-held, software controlled, diagnostic uitrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging. Power Doppler imaging(including Directional Power Doppler mode: S-Flow), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The UGEO H70c 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 UGEO H70c has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.

The UGEO H70chas 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

### 5. Intended Uses:

The UGEO H70c 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 Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

### 6. Technological Characteristics:

The UGEO H70cis substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX A30 Diagnostic Ultrasound System (K112339), UGEO G60 Diagnostic Ultrasound System (K122583) and MySono U6 Diagnostic Ultrasound System (K113381).

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

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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 representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

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

## April 12, 2013

SAMSUNG MEDISON CO., LTD % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K130803

Trade/Device Name: UGEO H70c Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 20, 2013 Received: April 2, 2013

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 UGEO H70c Diagnostic Ultrasound System, as described in your premarket notification:

### Transducer Model Number

| SC1-6 | L4-7 | P3-8 |
|--------|-------|-------|
| C2-6 | L5-13 | VN4-8 |
| CF4-9 | L7-16 | CW2.0 |
| EVN4-9 | PE2-4 | CW4.0 |

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

Page 2 - Mr. Job

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.


for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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UGEO H70c Diagnostic Ultrasound System

510(k) Premarket Notification

## SECTION 1.3 INDICATIONS FOR USE

510(k) Number (if known): _

Device Name: UGEO H70c Diagnostic Ultrasound System

Indications for Use:

The UGEO H70c 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 Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Pediatric, 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 Diagnostics and Radiological Health (OIR)

Indications for Use

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510(k) No.:

| Device Name:UGEO H70cDiagnostic 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<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) | N | N | N | | N | Note 1 | Notes 2, 7, 8, 9 |
| | Abdominal | N | N | N | N | N | Note 1 | Notes 2, 4, 7, 8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 10, 11 |
| | Neonatal Cephalic | N | N | N | | N | Note 1 | Note 2, 7, 8, 9 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-rectal | N | N | N | | N | Note 1 | Note 2, 7, 8, 9, 10, 11 |
| | Trans-vaginal | N | N | N | | N | Note 1 | Note 2, 7, 8, 9, 10, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppler includes Power (Amplitude) Doppler
Note 1: B+M, B+PW, B+C, B+PD,B+CW, B+C+PW, B+PD+PW,B+C+M, 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, pediatic and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note10: ElastoScan

Notel 1: Spatial Compound Imaging

#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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#### 510(k) No.:

.

Device Name: SC1-6for use with UGEO H70c 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) | N | N | N | N | N | Note 1 | Notes4, 7, 8, 9 |
| | Abdominal | N | N | N | | N | Note 1 | Notes7, 8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Notes 7, 8, 9 |
| | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, 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)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: ElastoScan

Note ! 1: Spatial Compound Imaging

### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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510(k) No.:

Device Name: C2-6 for use with UGEO H70c

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 2, 4, 7, 8, 9 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9 |
| | 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<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared byFDA K112339; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: ElastoScan

Note11: Spatial Compound Imaging

### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

#### Device Name: CF4-9 for use with UGEO H70c

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 1 only) | Specific<br>(Tracks 1 & 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 2, 7, 8, 9 |
| | Abdominal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 |
| | Small Organ (See Note 5) | P | P | P | P | P | Note I | Notes 2, 7, 8, 9 |
| | Neonatal Cephalic | P | P | P | P | P | Note I | Notes 2, 7, 8, 9 |
| | 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<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 |
| | Other (spec. ) | | | | | | | |

N= new indication; P= previously cleared byFDA K122583; E= added under Appendix E

Additional Comments:

Color Doppier includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, 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)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: ElastoScan

Note 11: Spatial Compound Imaging

### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

#### 510(k) Premarket Notification

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

### 510(k) No.: Device Name: EVN4-9for use with UGEO H70c 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 1 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 | | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | |
| | 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 by FDA K122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 8: 3D imaging

Note 9: Panoramic imaging

Note10: ElastoScan

Notell: Spatial Compound Imaging

### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

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

#### 510(k) Premarket Notification

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

## Device Name: L4-7 for use with UGEO H70c 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 | Note 1 | Note 2, 5, 6, 7, 9, 11 | | |
| | Intra-operative (See Note 6) | | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | |
| | 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 2, 5, 6, 7, 9, 11 | | |
| | Other (spec.) | | | | | | | | | |

N= new indication: P= previously cleared by FDA K112339; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 8: 3D imaging

Note 9: Panoramic imaging

Note10: ElastoScan

Notel I : Spatial Compound Imaging

#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

#### Indications for Use

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

510(k) No.:

### Device Name: L5-13 for use with UGEO H70c 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 | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 10, 11 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| Peripheral<br>Vessel | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K 122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note10: ElastoScan

Notell: Spatial Compound Imaging

### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

#### Device Name: L7-16 for use with UGEO H70c

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 1 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 2, 5, 6, 7, 9, 11 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 |
| | 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 2, 5, 6, 7, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDA K112339; E= added under Appendix E

#### Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, 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)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: ElastoScan

Note11: Spatial Compound Imaging

#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

#### Indications for Use

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

510(k) No .:

Device Name: PE2-4 for use with UGEO H70c

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 1 only) | Specific<br>(Tracks 1 & 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 by FDA K 12339; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+PW, B+PD+PW, B+C+M, 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, scroturn and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Panoramic imaging Note 10: ElastoScan

Note11: Spatial Compound Imaging

Note 11: Spatial Compound Imaging

#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

#### Device Name: P3-8 for use with UGEO H70c

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 1 & 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 by FDA K 103397; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1; B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual B, 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)

Note 8: 3D imaging

Note 9: Panoramic imaging

Note 10: ElastoScan

Notel 1: Spatial Compound Imaging

#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801.109)

Indications for Use

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

510(k) No.:

Device Name: VN4-8for use with UGEO H70c

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 1 & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | N | N | N | N | N | Note 1 | Note 2, 7, 8 |
| | Abdominal | N | N | N | N | N | Note I | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | N | N | Note 1 | Note 2, 7, 8 |
| | 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<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+M, B+PW, B+C, B+PD, B+C+PW, B+C+PW, B+PD+PW, B+C+M, 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)

Note 8: 3D imaging

Note 9: Panoramic imaging Note | 0: ElastoScan

Note11: Spatial Compound Imaging

Concurrence of CDRH…