SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM

K984203 · Shantou Institute of Ultrasonic Instuments · IYN · Nov 1, 1999 · Radiology

Device Facts

• Record ID: K984203
• Device Name: SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
• Applicant: Shantou Institute of Ultrasonic Instuments
• Product Code: IYN · Radiology
• Decision Date: Nov 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.

Device Story

SIUI Apogee 800 PLUS is an ultrasound imaging system consisting of a monitor, control module, chassis, and transducers (5-2C40 convex, 11-5L40 linear). It transmits ultrasound waves, receives echoes, and generates real-time 2D, M-mode, Doppler, Power, and color images. The system supports application-specific presets for automatic optimization and allows storage of measurements in patient reports. Used in clinical settings by healthcare professionals for diagnostic imaging. Output is displayed on a monitor to assist clinicians in patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ultrasound imaging system with analog beamformer. Supports 2D, M-mode, Doppler, Power, and color imaging. 8-bit gray scale (256 levels). Max frame rate 70 FPS. Max imaging depth 24 cm. Includes transducers (convex array 5-2C40, linear array 11-5L40). Preprogrammable settings and cineloop functionality.

Indications for Use

Indicated for fetal, abdominal, pediatric, small organ (thyroid, parathyroid, submaxillary gland, testes, breast), and peripheral vascular imaging. 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

• Advanced Technology Laboratories, Ultramark 9 HDI system (K903603)
• Interspec Inc Apogee RX 400 (K924231)

Submission Summary (Full Text)

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NOV - 1 1999

Image /page/0/Picture/1 description: The image shows the letters "SIUI" in a bold, sans-serif font. The letters are black and appear to be printed on a white background. The letters are evenly spaced and aligned horizontally. The image is clear and easy to read.

SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS 汕头超声仪器研究所

K984203

Premarket Notification [510(k)] Summarv

August 10, 1999 (revised)

Trade Name: SIUI Apoqee 800 PLUS Ultrasound Imaging System SIUI 5-2 C40 Transducer SIUI 11-5L40 Transduced

Common Name: Ultrasound Imaging System

Classification: This product is substantially equivalent to one or more of the products FDA has classified or has proposed classification, as Class II devices, including

Ultrasonic pulsed Doppler imaging system 21 CFR 892.1550 Ultrasonic pulsed echo imaging system 21 CFR 892.1560 Diagnostic ultrasonic transducer 21 CFR 892.1570

Manufacturer's Name: Shantou Institute of Ultrasonic Instruments Address: #2, Jinsha Road, M., Shantou Sez, 515041, China

Corresponding Official: Mr. Jinzhong Yao Title: President

Telephone: [phone] Fax: [phone]

Establishment Registration Number: 9615439

Predicate: Advanced Technology Laboratories, Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231

Device Description: Apoqee 800 PLUS transmits ultrasound waves. receives the echoes, and generates images based on information contained in the echoes.

The format in which the information is displayed depends on the imaging mode or modes that you select. The system is capable of

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real-time two-dimensional (2D) imaging, motion mode (M-mode) imaging, Doppler imaging, Power imaging, and color imaging.

The system supports application and exam type presets, which means that the system is automatically optimized for the scanhead and application you have selected. Additionally, analysis protocols are made available so that you can store measurements in the patient's report.

Physically the system consists of the monitor module, the control module, the main chassis, and transducers.

Intended Use: Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.

Technological Characteristics:_ See the attached four Comparison Tables for the SIUI Apoqee 800 PLUS and the ATL Ultramark 9.

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SIUI Apogee 800PLUS Ultrasound Imaging System

| Device<br>Type | Ophthalmic | Fetal | Abdominal | Pediatric | Small<br>Organ | Cardiac | Peripheral<br>Vascular |
|---------------------------|------------|-------|-----------|-----------|----------------|---------|------------------------|
| ATL<br>Ultramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SIUI<br>Apogee<br>800PLUS | No | Yes | Yes | Yes | Yes | No | Yes |

## ·1 Indications for Use

# 2 OPERATION MODES

| Device Type | 2-D | B | M | PW | CW | Color<br>Flow | HPRF | CPA | Color<br>M |
|---------------------------|-----|-----|-----|-----|-----|---------------|------|-----|------------|
| ATL<br>Ultramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | |
| SIUI<br>Apogee<br>800PLUS | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |

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SIUI Apogee 800PLUS Ultrasound Imaging System

## 3 DISPLAY FORMATS

| DISPLAY FORMATS | | SIUI<br>Apogee 800PLUS | ATL<br>Ultramark 9 |
|------------------------------|-----------------------------------|------------------------|--------------------|
| Full Screen | 2 D B-MODE | Yes | Yes |
| | M-MODE | Yes | Yes |
| | CFM | Yes | Yes |
| | COLOR M-MODE | Yes | Yes |
| | DOPPLER SPECTRUM | Yes | Yes |
| Top/Bottom<br>Split Screen | 2D/DOPPLER SPECTRUM | Yes | Yes |
| | 2D/M | Yes | Yes |
| | CFM/DOPPLER SPECTRUM | Yes | Yes |
| | CFM/M | Yes | Yes |
| | CFM/COLOR M | Yes | Yes |
| Side by Side<br>Split Screen | 2D/2D | Yes | Yes |
| | 2D/CFM | Yes | Yes |
| | CFM/CFM | Yes | Yes |
| | CFM/CPA | Yes | No |
| | 2D/2D ZOOM | Yes | Yes |
| | CFM/COLOR ZOOM | Yes | Yes |
| General<br>Formats | Freeze Frame | Yes | Yes |
| | Apex Invert | Yes | Yes |
| | Left/Right Reverse | Yes | Yes |
| | Video Invert for Doppler Spectrum | Yes | Yes |
| | Video Invert for M-Mode | Yes | Yes |

* CFM - COLOR FLOW IMAGING or COLOR DOPPLER

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SIUI Apogee 800PLUS Ultrasound Imaging System

#### Other Specifications 4

.

| | ATL Ultramark 9 | SIUI Apogee 800PLUS |
|----------------------------------------|---------------------------|----------------------------|
| Gray Scale | 256 (8bits) | 256 (8 bits) |
| Frame Rate (Max) | 156 FPS | 70 FPS |
| Beamformer | Digital | Analog |
| Signal post processing | Yes | Yes |
| Image Modification | 8x, continuously variable | 24x, continuously variable |
| Preprogrammability | Yes | Yes |
| Cineloop | Yes | Yes |
| Imaging depth (max) | 25 (cm) | 24 (cm) |
| Doppler measurable<br>velocities (max) | 13.6 m/s (for CW) | 8 m/s (for PW) |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 1999

Shantou Institute of Ultrasonic Instruments c/o Robert Morton President ORS 1106 Chiltern Drive Walnut Creek, CA 94596

Re: K984203 SIUI Apogee 800PLUS Ultrasound Imaging System Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN Dated: Auqust 9, 1999 Received: August 17, 1999

Dear Mr. Morton:

We have reviewed your Section 510(k) 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 SIUI Apogee 800PLUS Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

Convex Array 5-2C40 Linear Array 11-5140

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Robert Morton

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

CAPT. Daniel C. Schultz, M.D.

CAPT. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Re: K984203

SIUI Apogee 800PLUS Ultrasound Imaging System

## Indications for Use Form

## Diagnostic Ultrasound System Indications for Use Form Device Name: SIUI Apogee 800 PLUS

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | |
| Abdominal | | N | N | | | | | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | | | N | |
| Small Organ (specify) | | N | N | N | | N | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethrat | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Perpheral Vascular | | N | N | N | | N | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication

Additional Comments: Small organ includes: thyroid, parathyroid, submaxillary gland, testes and breast

Combined Modes: Fetal: B+M

| Abdominal: B+M |
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| Pediatric: B + M, B + PWD, B + Color, B + Color + M, B + Color + PWD |
| Small Organ: B + M, B+PWD, B + Color, B +Color +M, B+ Color + PWD |
| Peripheral Vascular: B+M, B+ PWD, B+ color, B + Color + M, B + Color + PWD |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |

Concurrence of CDRH, office of Device Evaluation (OBE)

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510(k) Number

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic

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Re: K984203

SIUI Apogee 800PLUS Ultrasound Imaging System

## 1. Scanhead Indications for Use Form Device Name: Convex Array 5-2 C 40

| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | N | N | | | | | | N | | |
| Abdominal | | N | N | | | | | | N | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | | | | | | N | | |
| Small Organ (specify) | | N | N | | | | | | N | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethrat | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Perpheral Vascular | | N | N | | | | | | N | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N=new indication

Additional Comments: Small organ includes: thyroid_parathyroid_submaxillary cland. Jestes and breast.

Combined Modes: Fetal: B+M. Abdominal: B+M.

Pediatric: B + M. Small Organ: B + M.

Peripheral Vascular: B+M.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF WEEDED

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Signature

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic

510(k) Number K984203

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### Re: K984203

SIUI Apogee 800PLUS Ultrasound Imaging System

## 2. Scanhead Indications for Use Form Device Name: Linear Array 11-5 L 40

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | | | N | |
| Small Organ (specify) | | N | N | N | | N | | | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethrat | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Perpheral Vascular | | N | N | N | | N | | | N | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N=new indication

Additional Comments: Small organ includes: thyroid, parathyroid, submaxillary gland, testes and breast

Combined Modes: Pediatric: B + M. B + PWD. B + Color + M. B + Color + M. B + Color + PWD

Small Organ: B + M B+PWD. B + Color. B +Color +M. B + Color + PWD

Peripheral Vascular: B+M. B+ PWQ, B+ color, B+ Color + M. B + Color + PWD

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Ka 510(k) Number

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