iuStar300 Medical Ultrasound Diagnostic System

K141720 · United Imaging Systems (Beijing) Co., Ltd. · IYN · Jul 23, 2015 · Radiology

Device Facts

• Record ID: K141720
• Device Name: iuStar300 Medical Ultrasound Diagnostic System
• Applicant: United Imaging Systems (Beijing) Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

Device Story

Mobile, software-controlled diagnostic ultrasound system; utilizes ultrasound transducers (convex, linear, micro-convex, phased array, volume) to acquire internal organ images. Operates via B-mode, M-mode, Pulse/Continuous Wave Spectral Doppler, Color Doppler, and Power Doppler. Transforms acoustic signals into visual diagnostic data for display. Used in clinical settings by physicians or sonographers for diagnostic imaging and fluid flow analysis. Includes measurement, reporting, and annotation tools. Benefits patients through non-invasive visualization of anatomy and pathology to support clinical diagnosis.

Clinical Evidence

Bench testing only. Performance validated against IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004, and ISO 10993 standards for electrical safety, acoustic output, and biocompatibility. Software validation performed.

Technological Characteristics

Mobile ultrasound system; supports 2D, M, PW/CW Doppler, Color/Power Doppler, 3D/4D imaging. Features: Uniview (adaptive speckle reduction), UniCT (spatial compounding), digital broadband beamforming. Transducer frequencies: 2MHz-14MHz. Compliance: IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004, ISO 10993.

Indications for Use

Indicated for visualization of internal organs for diagnostic purposes in patients requiring General, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal, and Cardiology ultrasound exams. Must be operated by qualified physicians or sonographers.

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

• ACUSON DIAGNOSTIC ULTRASOUND SYSTEM (K061946)
• S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K110510)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine.

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

July 23, 2015

United Imaging Systems (Beijing) Co., Ltd. % Mr. Jun Peng Principal Consultant P&L Scientific, Inc. 6840 SW 45th Lane, Unit 5 MIAMI FL 33155

Re: K141720

Trade/Device Name: iuStar300 Medical Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 6, 2015 Received: July 15, 2015

Dear Mr. Peng:

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.

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.

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

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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

# 510(k) Number (if known): K141720

Device Name: iuStar300 Medical Ultrasound Diagnostic System

## Indications for Use:

The iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

## (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)

Prescription Use: (Per 21 CFR 801.109) OR

Over-the Counter Use:

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

System: iuStar300 Medical Ultrasound Diagnostic System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | Note 1 | |
| | Abdominal | N | N | N | N | N | N | Note 1 | |
| | Intra-operative<br>(Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | |
| | Small Organ (Specify) | N | N | N | N | N | N | Note 1 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | |
| | Intravascular | | | | | | | | |
| | Other (Urology) | N | N | N | N | N | N | Note 1 | |
| | Other (OB/GYN) | N | N | N | N | N | N | Note 1 | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: ✓ __ | OR | Over-the Counter Use: __ |
|------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Per 21 CFR 807) |

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: L10-5, Linear Array

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------|------------------------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | N | N | N | N | | N | Note 1 | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | N | N | N | N | | N | Note 1 |
| | | Musculo-skeletal<br>(Superficial) | N | N | N | N | | N | Note 1 |
| | | Intravascular | | | | | | | |
| | | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | | N | Note 1 | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: <span style="text-decoration: overline;">✓</span> <span style="text-decoration: overline;"> </span> <span style="text-decoration: overline;"> </span> OR <span style="text-decoration: overline;"> </span> | Over-the Counter Use: <span style="text-decoration: overline;"> </span> <span style="text-decoration: overline;"> </span> | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------|
| (Per 21 CFR 801.109) | | (Per 21 CFR 807) |

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: C5-2, Convex

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | Note 1 | |
| | Abdominal | N | N | N | N | N | N | Note 1 | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | Note 1 | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/GYN) | N | N | N | N | N | N | Note 1 | |
| | Other (Urology) | N | N | N | N | N | N | Note 1 | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: _<br>(Per 21 CFR 801.109) | OR | Over-the Counter Use: _<br>(Per 21 CFR 807) |
|---------------------------------------------|----|---------------------------------------------|
|---------------------------------------------|----|---------------------------------------------|

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: EV9-4, Endo cavity

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler<br>(Amplitude) | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | N | N | N | Note 1 | |
| | Trans-vaginal | N | N | N | N | N | N | Note 1 | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: _<br>(Per 21 CFR 801.109) | OR | Over-the Counter Use: _<br>(Per 21 CFR 807) |
|---------------------------------------------|----|---------------------------------------------|
|---------------------------------------------|----|---------------------------------------------|

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: V5-2, Volume Probe

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler<br>(Amplitude) | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N | N | N | N | N | N | Note 1 | Note 3, 4 |
| | Abdominal | N | N | N | N | N | N | Note 1 | Note 3, 4 |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/GYN) | N | N | N | N | N | N | N | Note 1 |
| | Other (Urology) | N | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: <span style="text-decoration: overline;">✓</span> | OR | Over-the Counter Use: <span style="text-decoration: overline;">___</span> |
|---------------------------------------------------------------------|----|---------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | (Per 21 CFR 807) |

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: MC5-2, Micro Convex

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | Note 1 | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | | N | N | Note 1 | |
| | Cardiac Pediatric | N | N | N | | N | N | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: _ <b>✓</b> _<br>(Per 21 CFR 801.109) | OR | Over-the Counter Use: ____<br>(Per 21 CFR 807) |
|--------------------------------------------------------|----|------------------------------------------------|
|--------------------------------------------------------|----|------------------------------------------------|

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

System: iuStar300 Medical Ultrasound Diagnostic System Transducer: P4-2, Phased array

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

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-<br>Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (OB/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: 2D/M, 2D/PW, 2D/C, 2D/PD, 2D/DPD, 2D/PD/PW, 2D/C/PW

Note 2: Tissue Harmonic Imaging Note 3: 3D Note 5: Small Organ: breast, thyroid, testes.

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

| Prescription Use: ✓__ | OR | Over-the Counter Use: __ |
|-----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Per 21 CFR 807) |

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

## 510(k) Summary

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:

### The Assigned 510(k) Number is: k141720

### 1. Submitter Information:

#### Sponsor/510(K) Owner: .

United Imaging Systems (Beijing) Co., Ltd. 109 Bldg. 8, No. 8 West Dongbeiwang Rd. Haidian District, Beijing 100193 China Phone: [phone] Fax: [phone]

Dated: Monday, December 15, 2014

#### Contact Name: .

Mr. Jun Peng P&L SCIENTIFIC, INC. 6840 SW 45TH LN UNIT 5, MIAMI, FL 33155 Phone: [phone] Fax: [phone] Email: [e-mail]

## 2. Device Name

Trade Name: Medical Ultrasound Diagnostic System, Models iuStar300 Common Name: iuStar300:

## 3. Classification:

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

### 4. Predicate Devices:

| Name | K number | Manufacturer information |
|---------------------------------------------------|--------------|---------------------------------------|
| ACUSON<br>DIAGNOSTIC<br>ULTRASOUND SYSTEM | X300 K061946 | SIEMENS MEDICAL<br>SOLUTIONS USA INC. |
| S20 DIGITAL COLOR<br>DOPPLER ULTRASOUND<br>SYSTEM | K110510 | SONOSCAPE COMPANY<br>LIMITED |

## 5. Description of Device

The iuStar300 Medical Ultrasound Diagnostic System is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms.

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

iuStar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs and for medical diagnostic purposes only. It supports 2D, M Mode, CFM and Pulse and Continuous Wave Spectral Doppler, Color Doppler Energy and Directional Color Doppler Energy modes.

## 6. Intended Use

The iustar300 Medical Ultrasound Diagnostic System is intended for visualization of internal organs by ultrasound images for medical diagnostic purposes only. It must be operated by qualified and trained Physician or Sonographer. It can be used in following applications: General application, Abdominal, Vascular, OB/GYN, Urology, Breast, Small Parts (breast, thyroid, testes), Musculoskeletal, Superficial Musculoskeletal and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

| Name | Predicate device | Predicate device | Subject device |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K061946 | K110510 | k141720 |
| Device Trade<br>Name | ACUSON X300<br>DIAGNOSTIC<br>ULTRASOUND<br>SYSTEM | S20 DIGITAL<br>COLOR DOPPLER<br>ULTRASOUND<br>SYSTEM | iuStar300 Medical Ultrasound<br>Diagnostic System |
| Common Name | | | |
| Classification<br>Name | Ultrasonic Pulsed<br>Doppler Imaging<br>System | Ultrasonic Pulsed<br>Doppler Imaging<br>System | Ultrasonic Pulsed Doppler Imaging<br>System |
| Indications for<br>Use | The Siemens Acuson<br>X300 ultrasound<br>imaging system is<br>intended for the<br>following applications:<br>General Radiology,<br>Fetal, Abdominal,<br>Intraoperative,<br>Pediatric, Small Pans,<br>Neonatal/Adult<br>Cephalic, Cardiac,<br>Transesophageal,<br>Pelvic, Transcranial,<br>OB/GYN, Urology,<br>Vascular,<br>Musculoskeletal,<br>Superficial<br>Musculoskeletal, and<br>Peripheral Vascular<br>applications.<br>The system also<br>provides for the | The device is a general-<br>purpose ultrasonic<br>imaging instrument<br>intended for use by<br>a qualified physician<br>for evaluation of Fetal,<br>Abdominal, Pediatric,<br>Small Organ<br>(breast, testes, thyroid),<br>Cephalic(neonatal and<br>adult), Trans-rectal,<br>Trans-vaginal,<br>Peripheral Vascular,<br>Musculo-skeletal<br>(Conventional and<br>Superficial), Cardiac<br>(neonatal and adult),<br>OB/Gyn and Urology. | The iuStar300 Medical Ultrasound<br>Diagnostic System is intended for<br>visualization of internal organs by<br>ultrasound images for medical diagnostic<br>purposes only. It must be operated by<br>qualified and trained Physician or<br>Sonographer. It can be used in following<br>applications: General application,<br>Abdominal, Vascular, OB/GYN, Urology,<br>Breast, Small Parts (breast, thyroid, testes)<br>Musculoskeletal, Superficial<br>Musculoskeletal and Cardiology. Each<br>application includes a set of exams,<br>including the specific measurements,<br>reports, pictograms, annotations and<br>system presets. |
| measurement of<br>anatomical structures<br>and for analysis<br>packages that provide<br>information that is used<br>for clinical diagnosis<br>purposes. | | | |
| Classification | | | |
| | Ultrasonic Pulsed<br>Doppler Imaging<br>System 892.1550<br>IYN<br>Ultrasonic Pulsed Echo<br>Imaging System<br>892.1560<br>IYO<br>Diagnostic Ultrasound<br>Transducer<br>892.1570<br>ITX | Ultrasonic Pulsed<br>Doppler Imaging<br>System 892.1550<br>IYN<br>Ultrasonic Pulsed Echo<br>Imaging System<br>892.1560<br>IYO<br>Diagnostic Ultrasound<br>Transducer<br>892.1570<br>ITX | Ultrasonic Pulsed Doppler Imaging<br>System 892.1550<br>IYN<br>Ultrasonic Pulsed Echo Imaging System<br>892.1560<br>IYO<br>Diagnostic Ultrasound Transducer<br>892.1570<br>ITX |
| Probe Types | | | |
| Convex probe | √ | √ | √ |
| Linear probe | √ | √ | √ |
| Micro-Convex<br>Probe | √ | √ | √…