(342 days)
Not Found
No
The document describes standard ultrasound imaging technology and features like presets and analysis protocols, which are common in medical imaging devices and do not inherently indicate the use of AI/ML. There is no mention of AI, DNN, or ML in the text, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as an imaging system (ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging) for diagnosis, not for treating a condition or disease.
Yes
The device description states that the system generates images based on echoes and supports various imaging modes (2D, M-mode, Doppler, Power, color). It also mentions "analysis protocols" to store measurements in a patient's report. The "Intended Use / Indications for Use" section explicitly lists "imaging, measurement, color Doppler, and color velocity imaging" for various anatomical sites. These functionalities are typical for diagnostic imaging devices used to visualize and assess internal structures and blood flow to aid in diagnosis.
No
The device description explicitly states that the system physically consists of a monitor module, control module, main chassis, and transducers, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as performing "Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging" for various anatomical sites. This is a description of an imaging device used to visualize internal structures and blood flow.
- Device Description: The description details how the device transmits and receives ultrasound waves to generate images. This aligns with the function of an ultrasound imaging system.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or analysis of samples outside the body.
The device described is a standard ultrasound imaging system used for diagnostic purposes in vivo (within the body).
N/A
Intended Use / Indications for Use
Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.
Product codes
21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 892.1570, 90 IYN
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (thyroid, parathyroid, submaxillary gland, testes, breast), Peripheral Vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
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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
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: (86) 754-8250150 Fax: (86) 754-8251499
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.
2
SIUI Apogee 800PLUS Ultrasound Imaging System
| Device
Type | Ophthalmic | Fetal | Abdominal | Pediatric | Small
Organ | Cardiac | Peripheral
Vascular |
|---------------------------|------------|-------|-----------|-----------|----------------|---------|------------------------|
| ATL
Ultramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SIUI
Apogee
800PLUS | No | Yes | Yes | Yes | Yes | No | Yes |
·1 Indications for Use
2 OPERATION MODES
| Device Type | 2-D | B | M | PW | CW | Color
Flow | HPRF | CPA | Color
M |
|---------------------------|-----|-----|-----|-----|-----|---------------|------|-----|------------|
| ATL
Ultramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | |
| SIUI
Apogee
800PLUS | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | |
3
SIUI Apogee 800PLUS Ultrasound Imaging System
3 DISPLAY FORMATS
| DISPLAY FORMATS | | SIUI
Apogee 800PLUS | ATL
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
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
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
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
4
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 | ||
| 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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.
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
7
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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | |||||||
| Abdominal | N | N | N | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| 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 | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| 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 |
|---|
| 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)
4
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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8
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 | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| 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 | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| 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
2
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic
510(k) Number K984203
9
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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| 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 | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| 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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