RS80A DIAGNOSTIC ULTRASOUND SYSTEM

K141620 · Samsung Medison Co., Ltd. · IYN · Jul 2, 2014 · Radiology

Device Facts

• Record ID: K141620
• Device Name: RS80A DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Samsung Medison Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Story

RS80A is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via transducers and displays it in various modes: B-mode, Color/Power Doppler (including S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D imaging, and Elastoscan. 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 visualize structures and fluid flow, aiding in diagnosis and biopsy guidance. Benefits include non-invasive diagnostic imaging and improved clinical decision-making through advanced visualization and measurement tools.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. The device was evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable standards including IEC 60601-1, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Mobile diagnostic ultrasound system; supports linear, curved, endocavity, and phased array transducers (1.0-20.0 MHz). Modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Elastoscan. Patient contact materials tested to ISO 10993-1. Safety compliance: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2. Features include Quick Scan, Spatial Compounding, Auto IMT+, and 3D rendering. Software-controlled.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in fetal/obstetrics, abdominal, gynecological, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urological, cardiac, and peripheral vessel applications. Prescription use only.

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 WS80A Diagnostic Ultrasound System (K133329)
• UGEO HM70A Diagnostic Ultrasound System (K130803)
• ACCUVIX A30 Diagnostic Ultrasound System (K112339)
• ACCUVIX XG Diagnostic Ultrasound System (K103397)
• LOGIQ E9 Diagnostic Ultrasound System (K123564)
• B-CAD (K050846)

Submission Summary (Full Text)

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K141620
page 1 of 5

RS80ADiagnostic 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: | 82.2.556.3974 |

Data Prepared: March 24, 2013

2. Name of the device:

Common/Usual Name:

. Diagnostic Ultrasound System and Accessories

Proprietary Name:

RS80A 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 WS80A Diagnostic Ultrasound System (K133329) 1

UGEO HM70A Diagnostic Ultrasound System (K130803)

ACCUVIX A30 Diagnostic Ultrasound Svstem(K112339) -

ACCUVIX XG Diagnostic Ultrasound System (K 103397) -

LOGIQ E9Diagnostic Ultrasound System (K123564) -

-B-CAD (K050846)

The proprietary name of predicate device (K130803)was changedto UGEO HM70A Diagnostic ※ Ultrasound System from UGEO H70c Diagnostic Ultrasound System on FDADatabases.

510(k) Summary / Statement Certification

ATTACHEMENT I

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#### 4. Device Description:

The RS80A 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode.Harmonic imaging. Tissue Doppler imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A 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 RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

#### 6. Technological Characteristics:

The RS80Ais substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO WS80A Diagnostic Ultrasound System (K133329), UGEO HM70A Diagnostic Ultrasound System (K130803), ACCUVIX A30 Diagnostic Ultrasound System (K112339)and ACCUVIX XG Diagnostic Ultrasound System (K103397).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the Volume Navigation™(Needle Tracking) of GE's LOGIQ E9 (K123564) in regards to the device with Clear Track. It is substantially equivalent with respect to safety, effectiveness, and functionality to theMadipattern's B-CAD30System (K050846) in regards to the device with S-Detect.

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.

510(k) Summary / Statement Certification

ATTACHEMENT 1

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#### RS80ADiagnostic Ultrasound System

| Feature /<br>Characteristics | The subject<br>device<br>RS80A | The predicate devices<br>UGEO<br>WS80A<br>(K133329) | ACCUVIX<br>A30<br>(K112339) | UGEO<br>HM70A<br>(K130803) | ACCUVIX<br>XG<br>(K103397) | LOGIQ E9<br>(K123564) | B-CAD<br>(K050846) |
|--------------------------------------|--------------------------------|-----------------------------------------------------|-----------------------------|----------------------------|----------------------------|-----------------------|--------------------|
| Indication for Use | | | | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ | - |
| - Abdominal | √ | √ | √ | √ | √ | √ | - |
| - Gynecology | √ | √ | √ | √ | √ | √ | - |
| - Pediatric | √ | √ | √ | √ | √ | √ | - |
| - Small Organ | √ | √ | √ | √ | √ | √ | - |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ | - |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ | - |
| - Trans-rectal | √ | √ | √ | √ | √ | √ | - |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ | - |
| - Musculo-skeletal<br>(Conventional) | √ | √ | √ | √ | √ | √ | - |
| - Musculo-skeletal<br>(Superficial) | √ | √ | √ | √ | √ | √ | - |
| - Urology | √ | √ | √ | √ | √ | √ | - |
| - 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)<br>Doppler | √ | √ | √ | √ | √ | √ | - |
| - Continuous wave<br>(CW) Doppler | √ | √ | √ | √ | √ | √ | - |
| - Color Doppler | √ | √ | √ | √ | √ | √ | - |
| - Power Amplitude<br>Doppler | √ | √ | √ | √ | √ | √ | - |
| - Tissue Harmonic<br>Imaging | √ | √ | √ | √ | √ | √ | - |
| - 3D/4D imaging mode | √ | √ | √ | √ | √ | √ | - |
| - Combined modes | √ | √ | √ | √ | √ | √ | - |
| Safety & EMC<br>Compliance | | | | | | | |
| - IEC 60601-1 | √ | √ | √ | √ | √ | √ | - |
| - UL 60601-1 | | | | | | | |

# <Technological Characteristics Comparison Table>

510(k) Summary / Statement Certification

ATTACHEMENT I

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## RS80ADiagnostic Ultrasound System

| Feature /<br>Characteristics | The subject<br>device<br>RS80A | The predicate devices | | | | | |
|-----------------------------------------------|--------------------------------|----------------------------|-----------------------------|----------------------------|----------------------------|-----------------------|--------------------|
| | | UGEO<br>WS80A<br>(K133329) | ACCUVIX<br>A30<br>(K112339) | UGEO<br>HM70A<br>(K130803) | ACCUVIX<br>XG<br>(K103397) | LOGIQ E9<br>(K123564) | B-CAD<br>(K050846) |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | - |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ | √ | - |
| Acoustic Output Display<br>Standard | | | | | | | |
| Track 3 | √ | √ | √ | √ | √ | √ | - |
| Patient Contact<br>Materials | | | | | | | |
| Tested to ISO 10993-1 | √ | √ | √ | √ | √ | √ | - |
| Functionality | | | | | | | |
| - Quick Scan (Q Scan) | √ | √ | √ | √ | √ | - | - |
| - Spatial Compound<br>Imaging | √ | √ | √ | √ | √ | - | - |
| - SMDR (SMDR evo) | (1) | √ | √ | √ | √ | - | - |
| - Auto IMT+<br>(Auto IMT) | √ | √ | √ | √ | √ | - | - |
| - Elastoscan | √ | √ | √ | √ | √ | - | - |
| - Panoramic | √ | √ | √ | √ | √ | - | - |
| - 3D Imaging<br>(Volume Data<br>Acquisition) | √ | √ | √ | √ | √ | - | - |
| - 3D Imaging<br>presentation | | | | | | - | - |
| 3D Cine/4D Cine | √ | √ | √ | √ | √ | - | - |
| - 3D Rendering<br>MPR(Multi Planer<br>Render) | √ | √ | √ | √ | √ | - | - |
| - 3D XI | | | | | | | |
| MSV(Multi Slice<br>View)<br>Oblique View | √ | √ | √ | √ | √ | - | - |
| - 3D MXI | | | | | | | |
| Volume Slice, Mirror<br>View | √ | √ | √ | √ | √ | - | - |
| - Volume CT | √ | √ | √ | √ | √ | - | - |
| - 3D MagiCut | √ | √ | √ | √ | √ | - | - |
| - Volume Calculation<br>(VOCAL, XI<br>VOCAL) | √ | √ | √ | √ | √ | - | - |
| - XI STIC | √ | √ | √ | √ | √ | - | - |
| - HDVI | √ | √ | √ | √ | √ | - | - |
| - FRV | (2) | √ | √ | | | | |
| - ADVR | √ | √ | √ | √ | √ | - | - |
| - Clear Track | √ | | | | | √(3) | |
| - S-Detect | √ | | | | | | √(4) |

l ) The name of the feature is changed to ClearVision.

2) The name of the feature is changed to Realistic Vue.

3) Volume Navigation (Needle Tracking)

4) B-CAD

510(k) Summary / Statement Certification

ATTACHEMENT 1

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RS80ADiagnostic Ultrasound System

- 7. A brief discussion of the bench and non-clinical tests conducted on the subject device The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal,
electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The RS80A 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. RS80A, 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 RS80Ato 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/5/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three curved lines that resemble a stylized human figure.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Flealth Service

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

July 2, 2014

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

Re: K141620

Trade/Device Name: RS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX Dated: June 16, 2014 Received: June 17, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the Rs80a Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number

| CA<br>1<br>A<br>. /<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ﻟ<br>7-1<br>6-4 - | V5-9 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 1999<br>-<br>100 | t<br>i<br>ﺗ<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 14<br>1<br>J<br>----- |
| 144 | 1.42-9A | ~W6.6<br>A & AND LEASE COLLECT |
| r of<br>t<br>:<br>-<br>---- | DE7<br>.<br>4 - 4 Hourd | |
| 1<br>1<br>l<br>AS measure | DM<br>' -{}/ | |

If your device is classified (see above) into cither class 11 (Special Controls) or class 111 (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.

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

Page 2-Mr. 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); 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K141620

Device Name

RS80A Diagnostic Ultrasound System

Indications for Use (Describe)

The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obsterics, Abdominal. Gynecology, Pediatric, Small Organ, Neonatal Cephalic. Adult Cephalic. Trans-rectal, Trans-vaginal. Muscular-Skeletal (Conventional. Superficial), Urology. Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. O'Hara

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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#### 510(k) No.:

Device Name: RS80ADiagnostic 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/Obstetrics (See Note 3) | N | N | N | | N | Note 1 | Notes 2, 4, 7, 8, 9, 11, 14 |
| | Abdominal (See Note 10) | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | N | N | N | | N | Note 1 | Notes 8, 9, 11 |
| | Small Organ (See Note 5) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12. 14 |
| | Neonatal Cephalic | N | N | N | | N | Note 1 | Notes 8, 9 |
| | Adult Cephalic | N | N | N | N | N | Note 1 | Notes 7 |
| | Trans-rectal | N | N | N | | N | Note 1 | Notes 2,7, 8, 9, 11, 12 |
| | Trans-vaginal | N | N | N | | N | Note 1 | Notes 2, 7, 8, 9, 11, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 2, 5, 6. 7, 8. 9, 11, 14 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | N | N | N | | N | Note 1 | Notes 2,7, 8, 9, 12 |
| | Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4, 7 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Notes 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, 14 |
| | Other (spec.) | | | | | | | |

N= new indication. P= previously cleared by FDA. F= added under Appendix F.

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Coldr Dopper includes Power (Amplinder) Dopper
Nate 1: B+M, B+PW, B+C, B+PD, B+DPD, B+TD, B+C+PW, B+PL+PW, B+PD+PW, B+C+M,Dusl/Quad, B+C+CW, B+PD+CW, B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3; Includes infersility monitoring of follicle development

Note 4 Color M-mode

Note 5 : For example: thyroid, breast, scrowm and penis in adult, pediatic and nennalal palients

- 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

Note | 1: Panoramic imaging

Note 11: Panoramic
Note 12: Chauffeur

Note 12: FlastoScan

Note 13: Includes Urology/Prostate

Note 14: Cicar Track

#### Concurrence of Center for Devices und Radiological Heulth (CDRH) Prescription Use (Por 21 CFR 801 109)

Indication for use

page 2 of 15

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510(k) No.:

#### Device Name: CA !-7A for use with RS80A

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/Obstetrics (See Note 3) | N | N | N | | N | Note 1 | Notes 2,4,7,8,9,11,14 |
| | Abdominal (See Note 10) | N | N | N | | N | Note 1 | Notes 2,6,7,8,9,11,14 |
| | 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 | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | |
| Vessel | Other (spec.) | | | | | | | |

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

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

ittonal Comments:
Colar Doppler includes Power (Anuplinde) Dopler
Nove : B+M, B+PW, B+C, B+DD, B+DPD, B+C'+PW, B+C+PW, B+C+PD+PW, B+PD+PW, B+C+M,I>xlV,Nxl/Qhad, B+C+CW, B+PD+CW. B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3. Includes inferiility monitoring of fullicle development

Nose 4: Calor M-mode

Note 4: Color M-hiode

Note 6 Abdominal organs and peripheral vessel
Note 7: Tissue Hamionic Imaging (THI)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9. Spanal Compound Imaging

Note 10 Includes Renal, Gynecology/Pelvis

Note i 1 Panoramic imaging

Note | 2: ElastoScan

Note 13: Includes Urology/Prostate Note 14: Clenr Track

> Concurrence of Center for Devices and Radiological Health (CDRH) Preseription Use (Per 21 CFR 801 109)

> > Indication for use

page 3 of 15

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

510(k) No.:

#### Device Name: C2-6 for use with RS80A

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/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 2,6, 7, 8, 9, 11 |
| | 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 | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | 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 K 130803. I = added under Appendix Li

Additional Comments:

thouar Connineludes Power (Amplitude) Doppler

Color Dopper Includes Powel (Angliade) Dripler
Note 1: B+M, B+PW, B+C, B+PD, B+DY!), B+I'D, B+C+PW, B+PI>+PW, B+PID+PW, B+C+M.Iball(Xiad, B+C+CW, B+PD+CW. B+F. B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infectibity monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrown and penis in adult, pediative and nevealal patients

Note 6: Abdominal organs and peripheral vessel
Note 7: Tissue Harmonic Imaging (THI)

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis

Nolc 11: Ponoramic imaging

Nolc 12: FlastoScan

Note 13: Includes Urology/Prostate

Note 14: Clear Track

#### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 4 of 15

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

510(k) No.:

#### Device Name: CF4-9for use with RS80A

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/Obstetrics (See Note 3) | | | | | | | | |
| | Abdominal(See Note 10) | P | P | P | | P | Note 1 | Notes 8, 9, 11 | |
| | Intra-operative (See Note 6) | | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | | P | Note 1 | Notes 8, 9, 11 | |
| | Small Organ (See Note 5) | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 8, 9, 11 | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (See Note 13) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | | |
| | Other (spec.) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 8, 9, 11 | |
| | Other (spec.) | | | | | | | | |

N= new indication; P= previously cleared by FDA K I 30803; L= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper includes Power (Ampliude) Doper
Note I: B+M, B+PW, B+C, B+PD, B+DPD, B+C+PW, B+PD+PW, B+PD+PW, B+TD+PW, B+C+M,Izual/Quad, B+C+CW. B+PD+CW, B+E., B+B/C

Note 2: Includes imaging for guidance of biopsy

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 neonalal patients

Note 6: Abdominal organs and peripheral vesse!

Note 7: Tissue Harmonic Imaging {THI)

- Nole 8: 3D imaging
Note 9: Spanial Compound Imaging
Note 10: Includes Renal, Gynecolugy/Pelvis

Note 10: Includes Renal, Gynecology/Pelvis

- Note I I Panoranic unaging
- Note 12. FlastoScan

Note 13. Includes Urology/Prostate

Note 14 Clear Track

Concurrence of Center for Devices and Radiological Health {CDRH} Prescription Use (Per 21 CFR 801.109)

Indication for use

page 5 of 15

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

510(k) No.:

Device Name: E3-12Afor use with RS80A

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/Obstetrics (See Note 3) | P | P | P | | P | Note I | Notes 2, 7, 8, 9 |
| | Abdominal(See Note 10) | P | P | P | | P | Note I | Notes 2, 7, 8, 9, 12 |
| | Intra-operative (See Note 6) | | | | | | | |
| | Intra-operative (Neuro.) | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (See Note 3) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | Note I | Notes 2, 7, 8, 9, 12 |
| | Trans-vaginal | P | P | P | | P | Note I | Notes 2, 7, 8, 9, 12 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Cardiac) | | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | P | P | P | | P | Note I | Notes 2, 7, 8, 9, 12 |
| | 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 K133329; E= added under Appendix E

Additional Comments:

Colar Doppler includes Power (Amplitude) Doppler

Cold Llopper Includes Power (Amplude) Lopper
Note I: B+M, B+PW, B+C, B+PD, B+DPI), B+TD, B+C'W, B+C+PW, B+PD+PW, B+TIX+PW, B+C+M,Dual/Quad. B+C+CW, B+PD+CW, B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2: Includes interior for guidance of biopsy
Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathytoid, breast, scroum and penis in adult, pediatic and necessar patiens

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Hannonic Imaging (THI)

- Note 8: 3D imaging
Note 9: Spatial Compound Imaging

Note 10: Includes Renal. Ginecology/Pelvis

- Note II. Panoramic imaging
- Note 12: ElastoScan

Note 13. Includes Urology:140state Note 14 Clear Track

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

page 6 of 15

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

510(k) No.:

#### Device Name: L3-12A for use with RS80A

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/Obstetrics (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) | P | P | P | | P | Note I | Note 2, 5, 6, 7, 8, 9, 11, 12,14 |
| | 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, 8, 9, 11, 14 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note I | Note 2, 5, 6, 7, 8, 9, 11, 14 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esophageal (Cardiac) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | Note I | Note 2, 5, 6. 7, 8, 9, 11. 14 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by:FDA K133329; L=added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Colar Dopper includes Power (Amplinde) Dopper B+PD+CW. B+E, B+B/C

Note 2: Includes imaging for guidance of biopsy

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertitity montoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, parathyroid, breast, scrolum and penis in adult, pediativ and neonalal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

- Note 8: 3D imaging
Note 9: Spatial Compound linaging

Note 10: Includes Renal, Gynecology/Pelvis

- Note II: Panoranic imaging
Note 12: ElastoScan

Note 13. Includes Urology/Prostate Note 14: Clear Track

#### Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801 109)

Indication for use

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

510(k) No .:

## Device Name: L5-13 for use with RS80A

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/Obstetrics (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) | P | P | P | | P | Note 1 | Note 2, 5, 6, 8, 7, 9, 11, 12 |
| | 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, 8, 9, 11 |
| | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 |
| | Intra-luminal | | | | | | | |
| | Other (See Note 13) | | | | | | | |
| | 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, 8, 9, 11 |
| | Other (spec.) | | | | | | | |

N= new indication; P= previously cleared by FDAK 130803; L= added under Appendix L

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Color Dopper includes Power (Amphide) Dopper
Note I: B+M, B+PW, B+C, B+DPD, B+ID, B+C+PW, B+C+PW, B+PD+PW, B+DM)>+PW, B+C+M,Inal/Qhad, B+C+CW, B+PD+CW, B+E. B+B/C

Note 2: Includes imaging for guidance of biopsy.

Note 2: Includes imaging for guidance of biopsy
Note 3: Includes infertility…