UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM

K132861 · Samsung Medison Co., Ltd. · IYN · Oct 4, 2013 · Radiology

Device Facts

• Record ID: K132861
• Device Name: UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Oct 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The UGEO H60 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-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via transducers; displays B-mode, M-mode, Color/Power Doppler (S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, and real-time 4D imaging. Operator (physician/technician) uses system to measure anatomical structures and perform analysis. Features include Quick Scan (Q Scan), Spatial Compound Imaging, Dynamic MR Plus (SMDR), Auto IMT, 3D/4D volume acquisition, and e-Motion Marker. System displays mechanical and thermal indices. Output aids clinicians in diagnosis and clinical decision-making; benefits include non-invasive visualization of internal structures and fluid flow.

Clinical Evidence

Bench testing only. No clinical studies required. Device evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety per standards including IEC 60601-1, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, and ISO 10993-1.

Technological Characteristics

Mobile ultrasound system; linear, curved, endocavity, phased array, and static probes (1.0-20.0 MHz). Patient contact materials tested to ISO 10993-1. Connectivity includes standard ultrasound display and analysis. Software-controlled; complies with IEC 60601-1, IEC 60601-2-37, and IEC 60601-1-2. Features include 3D/4D imaging, Doppler modes, and automated measurement tools (Auto IMT, VOCAL).

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 (conventional/superficial), cardiac (adult/pediatric), and peripheral vessel applications.

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

• UGEO G60 Diagnostic Ultrasound System (K122583)
• UGEO HM70A Diagnostic Ultrasound System (K130803)

Submission Summary (Full Text)

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K132861
Page 1 of 4

UGEO H60 Diagnostic Ultrasound Syste

510(k) Premarket Notification

## 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)

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

Contact Person: Kyeong-Mi, Park Regulatory Affairs Manager

82.2.2194.1373 Telephone: Facsimile: 82.2.556.3974

Data Prepared: July31, 2013

# 2. Name of the device:

| Common/Usual Name: | | |
|----------------------------------------------|-----------|--------------|
| Diagnostic Ultrasound System and Accessories | | |
| Proprietary Name: | | |
| UGEO H60 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:

- -UGEO G60 Diagnostic Ultrasound System(K122583)
- -UGEO HM70A Diagnostic Ultrasound System(K130803)
- * The proprietary name of predicate device (K122583) was changed to UGEO H60 Diagnostic Ultrasound System from UGEO G60 Diagnostic Ultrasound System.

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### 4. Device Description:

The UGEO H60 is a general 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(including Directional Power Doppler mode, S-Flow), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO H60 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 H60 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

#### 5. Intended Uses:

The UGEO H60 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-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

### 6. Technological Characteristics:

The UGEO H60is substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO H60 Diagnostic Ultrasound System (K122583) and UGEO HM70A Diagnostic Ultrasound System (K130803).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the Bodymarker of UGEO H60 (K122583) and UGEO HM70A (K130803) in regards to the device with e-Motion Marker. 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.

These are described in detail in the technological characteristics comparison table as below.

| Feature / Characteristics | The subject device<br>UGEO H60 | The predicate devices | |
|---------------------------|--------------------------------|-----------------------|-------------------------|
| | | UGEO H60<br>(K122583) | UGEO HM70A<br>(K130803) |
| Indication for Use | | | |
| - Fetal | ✓ | ✓ | ✓ |
| - Abdominal | ✓ | ✓ | ✓ |
| - Pediatric | ✓ | ✓ | ✓ |
| - Small Organ | ✓ | ✓ | ✓ |
| - Neonatal Cephalic | ✓ | ✓ | ✓ |
| - Adult Cephalic | ✓ | ✓ | ✓ |
| - Trans-rectal | ✓ | ✓ | ✓ |
| - Trans-vaginal | ✓ | ✓ | ✓ |

### <Technological Characteristics Comparison Table>

510(k) Summary / Statement Certification

#### ATTACHEMENT 1

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# UGEO H60 Diagnostic Ultrasound System

| Feature / Characteristics | The subject device<br>UGEO H60 | The predicate devices<br>UGEO H60<br>(K122583) | UGEO HM70A<br>(K130803) |
|------------------------------------------------|--------------------------------|------------------------------------------------|-------------------------|
| - Musculo-skeletal (Conventional) | √ | √ | √ |
| - Musculo-skeletal (Superficial) | √ | √ | √ |
| - Cardiac Adult | √ | | √ |
| - Cardiac Pediatric | √ | | √ |
| - Peripheral vessel | √ | √ | √ |
| Scanhead Types | | | |
| - Linear Array | √ | √ | √ |
| - Curved Linear Array | √ | √ | √ |
| - Endocavity | √ | √ | √ |
| - Phased Array | √ | | |
| - Static Probes | √ | | |
| Scanhead Frequency | | | |
| 1.0 - 20.0 MHz | √ | √ | √ |
| Modes of Operation | | | |
| - B-mode | √ | √ | √ |
| - M-mode | √ | √ | √ |
| - Pulsed wave (PW) Doppler | √ | √ | √ |
| - Continuous wave (CW) Doppler | √ | | √ |
| - Color Doppler | √ | √ | √ |
| - Power Amplitude Doppler | √ | | √ |
| - Tissue Harmonic Imaging | √ | √ | √ |
| - 3D/4D imaging mode | √ | √ | √ |
| - Combined modes | √ | √ | √ |
| Safety & EMC Compliance | | | |
| - IEC60601-1 | | | |
| - UL 60601-1 | √ | √ | √ |
| - CSA C22.2 No.601.1 | | | |
| - IEC 60601-2-37 | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ |
| Acoustic Output Display Standard | | | |
| Track 3 | √ | √ | √ |
| Patient Contact Materials | | | |
| Tested to ISO 10993-1 | √ | √ | √ |
| Functionality | | | |
| - Quick Scan (Q Scan) | √ | √ | √ |
| - Spatial Compound Imaging | √ | √ | √ |
| - SMDR (Dynamic MR Plus) | √ | √ | √ |
| - Auto IMT | √ | | √ |
| - 3D Imaging<br>(Volume Data Acquisition) | √ | | √ |
| - 3D Imaging presentation<br>(3D Cine/4D Cine) | √ | √ | √ |
| - 3D Rendering<br>MPR(Multi Planer Render) | √ | √ | √ |
| - 3D XI<br>MSV(Multi Slice View) | √ | √ | √ |
| Oblique View | | | |

510(k) Summary / Statement Certification

.

. . . .

·

ATTACHEMENT 1

.

・

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UGEO H60 Diagnostic Ultrasound System

| | The subject device | The predicate devices | |
|------------------------------|--------------------|-----------------------|-------------------------|
| Feature / Characteristics | UGEO I160 | UGEO H60<br>(K122583) | UGEO HM70A<br>(K130803) |
| - Volume Calculation (VOCAL) | √ | √ | √ |
| - Volume NT/IT | √ | √ | √ |
| - e-Motion Marker | √ | √1) | √1) |

l) BodyMarker

## 7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompaibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The UGEO H60 and its application comply with voluntary standards as below:

- 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
- ISO10993-1, Biocompatibility
- ISO14971, Application of risk management to medical devices

#### Summary of Clinical Tests:

Not applicable. The subject of this submission, UGEO H60, did not require clinical studies to support substantial equivalence.

## 8. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the UGEO H60to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

#### END of 510(K) Summary

510(k) Summary / Statement Certification

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping shapes, resembling a stylized caduceus or a symbol representing health and human services.

Public Health Service

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

October 4, 2013

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Service LLC. 1394 25th Street N W BUFFALO MN 55313

Re: K132861

Trade/Device Name: UGEO H60 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: September 11, 2013 Received: September 12, 2013

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 UGEO H60 Diagnostic Ultrasound System, as described in your premarket notification:

## Transducer Model Number

| CS1-4 | C2-8 | CF4-9 | ER4-9 | EVN4-9 |
|--------|-------|-------|-------|--------|
| L5-13 | 3D2-6 | VE4-8 | 3D4-9 | CF2-8 |
| LF5-13 | PE2-4 | SP3-8 | CW2.0 | CW4.0 |

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mark Job

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 (OS) 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/ycm 115809.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 Shing Chun Benny Lam, Ph.D. at [phone].

Sincerely yours,

Smh)

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

for

Enclosures

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UGEO H60 Diagnostic Ultrasound System

### INDICATIONS FOR USE

510(k) Number (if known): K132861

Device Name: UGEO H60 Diagnostic Ultrasound System

Indications for Use:

The UGEO H60 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 Pediatric and Peripheral vessel

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

> K132861 510(k)________________________________________________________________________________________________________________________________________________________________________

Indication for use

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#### 510(k) No.:

| Device Name:UGEO H60Diagnostic 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 (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8 |
| | Abdominal/(See Note 10) | P | P | P | N | P | Note 1 | Notes 2, 4, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | N | P | Note 1 | Note 2, 4, 5, 6, 7, 8, 9 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Note 2, 7, 8 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Notes 4, 7 |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4, 7 |
| | Cardiac Pediatric | N | N | N | N | N | Note 1 | Notes 4, 7 |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | N | P | Note 1 | Note 2, 5, 6, 7, 8, 9 |
| | Other (spec.) | | | | | | | |

N= new indication: P= previously cleared by FDA K122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Nate I: B+M, B+PW, B+CW, B+C, B+PD, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW,Dwl(Quad (B+C, B+PD,B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertifity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, serotum 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

Indication for use

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No .:

### Device Name: CS1-4 for use with UGEO H60

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 | Note 1 | Notes 2, 7, 8 |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 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 K122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note I. B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+C+PW, B+DPD+PW, B+C+M, B+C+CW, Dwl/Quod (B, B+C, B+PD, B+TD, B+DPD)

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)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

Concurrence of CDRH, Other of in I'uro Diagnostics and Radiological Health (OIR) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 3 of 17

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

### Device Name: C2-8 for use with UGEO H60

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 & 111) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 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 byFDA K122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Coll Dopper alleddes 1 over (1. mipmato) Bopper
Note 1: B+M, B+PW, B+CW, B+C, B+DPD, B+C+PW, B+D+PW, B+DPD+PW, B+C+CW, B+C+CW, Dusli(Qual (B, B+C, B+PD, B+TD, B+DPD)

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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

Indication for use

page 4 of ! 7

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

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No .:

## Device Name: CF4-9 for use with UGEO H60

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 ( <i>See Note 3</i> ) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Abdominal ( <i>See Note 10</i> ) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Small Organ ( <i>See Note 5</i> ) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| | 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 |
| | 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 I: B • M, B • PW, B • C, B • PD, B • DPD, 8 • C • PW, B • DPD • PW, B • DPD • PW, B • C • N, B • C • C • C • C • C • C • C • C • C • C • C • C • C • C • • • • • • • • • B+TD, B+DPD)

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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

Indication for use

page 5 of 17

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

# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

-.

# Device Name: ER4-9 for use with UGEO H60

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 (See Note 10) | | | | | | | |
| | 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 I | Notes 2, 8 |
| | Trans-vaginal | P | P | P | | P | Note I | Notes 2, 8 |
| | 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 Doppier includes Power (Amplitude) Doppler

Color Dopper neudes Poset (Anipitade) Doppel
Note I: B+M, B+C W, B+C, B+PD, B+C+PW, B+PD+PW, B+DPD+PW, B+DPD+PW, B+C+C+M, B+C+CW, DxulQuad (B, B+C, B+PD, B+TD, B+DPD)

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, scrolum and penis in adult, pediatric and neonalal patients

Note 6: Abdominal organs and peripheral vessel

Note 7. Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

Indication for use

page 6 of 17

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

510(k) No.:

Device Name: EVN4-9 for use with UGEO H60

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 Imaging<br>& Other | Fetal (See Note 3) | | | | | | | |
| | Abdominal (See Note 10) | | | | | | | |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 5) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 8 |
| | 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 by FDA K122583; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Doppen nicious I Gwy (Aniphiale) Dopper.
Note I: B+M, B+PW, B+C, B+C, B+C+PW, B+C+PW, B+C+PW, B+C+PW, B+C+C+M, B+C+CW, Dusl/Qued (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infectility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathytoid, 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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

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

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-13 for use with UGEO H60

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 (See Note 10) | | | | | | | |
| | 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 |
| | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 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 2, 5, 6, 7, 9 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 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 2, 5, 6, 7, 9 |
| | 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+CW, B+C, B+C, B+DPD, B+C+PW, B+PD+PW, B+DPD+PW, B+C+M, B+C+CW, B+C+CW, Dwl/Qws1(B, B+C, B+PD, B+TD, B+DPD)

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: Spatial Compound Imaging

Note 10: Includes Renal, Gynecology/Pelvis

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

Indication for use

page 8 of7 7

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

510(k) No.:

Device Name: 3D2-6 for use with UGEO H60 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

r

| 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 | Note 1 | Note 2, 7, 8 |
| | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | 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 | 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 I; B+M, B+PW, B+C, B+PD, B+C+PW, B+PD+W, B+PD+W, B-DPD+PW, B+C+M, B+C+M, B+C+CW, DwilQuad (B, B+C, B+PD, B+TD, B+DPD)

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: Spatial Compound Imaging

Note 10: Includes Renal. Gynecology/Pelvis

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

Indication for use

page 9 of 17

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

| General<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) |
|---------------------------|------------------------------|---|---|-----|-----|-------------------|----------------------|------------------|
| Ophthalmic | | | | | | | | |
| | Fetal (See Note 3) | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | 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.) | | | | | | | |

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+DPD, B+C+PW, B+DPD+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dusl(Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-modc

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: Spatial Compound Imaging

Note 10: Includes Renal. Gynecology/Pelvis

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

Indication for use

page 10 of17

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

510(k) No .:

Device Name: 3D4-9 for use with UGEO H60

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 Imaging<br>& Other | Fetal ( <i>See Note 3</i> ) | | | | | | | |
| | Abdominal ( <i>See Note 10</i> ) | | | | | | | |
| | Intra-operative ( <i>See Note 6</i> ) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ ( <i>See Note 5</i> ) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8 |
| | Trans-urethral |…