(295 days)
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No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific AI/ML-driven image processing techniques. The description focuses on standard ultrasound technology components.
No
The device is described as a "Diagnostic ultrasound imaging" system, and its intended use is to make "tomographic images... observable on a video monitor," which is consistent with diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging of the human body".
No
The device description explicitly states it is a "compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC)" and is a "main unit" that is "portable and is separable from other equipment". This indicates it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device description: The description clearly states that this is an "ultrasound imaging system" that uses "ultrasonic pulsed echo imaging" to create "tomographic images" of internal organs and a fetus. This is a non-invasive imaging technique performed on the body.
- Intended Use: The intended use is "Diagnostic ultrasound imaging of the human body," which aligns with in-vivo imaging, not in-vitro testing of samples.
Therefore, based on the provided information, this device is a diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ultrasonic pulsed echo imaging and measurement for fetal, abdominal, and adult cardiac imaging as well as adult cardiac M-mode.
Diagnostic ultrasound imaging XXXXOQQQWGXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX Indications For Use: (Specify) of the human body as follows:
Fetal: B mode
Abdominal: B mode
Cardiac Adult: M mode
Diagnostic ultrasound imaging 예뻐서 예뻐서 있었고 있었 Indications For Use: (Specify) of the human body as follows:
Fetal: B mode
Abdominal: B mode
Cardiac Adult: B, M mode
Product codes
90 IYO, 90 ITX
Device Description
Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasonic pulsed echo imaging
Anatomical Site
adult heart, abdominal organ, fetal
Indicated Patient Age Range
Adult, Fetal
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Hitachi Medical Corporation EUB-310, K862867
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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CHAMOT INSTITUTE OF ULTRASTRUCTURE
無障礙 強 印度 無因 三十
MAY 2 9 1997
Premarket Notification [510(k)] Summary
July 30, 1996 (Revised 5/6/97)
Trade Name: CTS-285 with EZU-PL21 and EZU-PC3B Transducers
Common Name: Diagnostic Ultrasound System
Classification Name: Ultrasonic Pulsed Echo Imaging System, 90 IYO (per 21 CFR section 892.1560)
Shantou Institute of Ultrasonic Instruments Manufacturer's Name: #2, Jinsha Road, M., Address: Shantou Sez, 515041, China
Corresponding Official: Mr. Jinzhong Yao Title: President
Telephone: (86) 754-8250150 Fax: (86) 754-8251499
Hitachi Medical Corporation EUB-310, K862867 Predicate:
Device Description: Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.
Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal, abdominal, and adult cardiac imaging as well as adult cardiac M-mode.
Technological Characteristics: See the attached "Comparison List" of the SIUI CTS-285 and the Hitachi EUB-310.
関連アレア アスト 205 1459
했다.2087000만 51504 : idd: Jinsha Road i Frantiou China 路唯一中国有限市 在世界活 Program Collectors
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1
COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT
الموالي
| Performance | CTS-285 (portable) (SIUI) | EUB-310A (HITACHI) | |
|---|---|---|---|
| main | |||
| unit | scanning mode | electronic linear scanning (compa- | |
| tible 64 elements linear probe) | |||
| electronic convex sector (compatible | |||
| convex probe of 64 elements) | electronic linear scanning (compa- | ||
| tible 80 elements linear probe) | |||
| electronic convex sector (compatible | |||
| convex probe of 80 elements | |||
| display mode | B mode. B/B mode. M mode. B/M mode | ||
| simultaneously | B mode. B/B mode. M mode. B/M mode | ||
| simultaneously | |||
| measurement | in B mode display: distance, area | ||
| and circumference | |||
| in M mode display: time interval, | |||
| velocity, depth and heart rate | in B mode display: distance, area | ||
| and circumference | |||
| in M mode display: time interval, | |||
| velocity, depth and heart rate | |||
| calculation | area, circumference, volume, heart | ||
| rate, pregnant weeks and heart | |||
| function | area, circumference, volume, heart | ||
| rate, pregnant weeks and heart | |||
| function | |||
| focusing mode | 4-steps dynamic focusing with | ||
| variable aperture and lens focusing | 4-steps dynamic focusing with | ||
| variable aperture and lens focusing | |||
| scanning width | linear scanning: 3.5MHz probe 102mm. | ||
| convex sector scanning probe: sector | |||
| angle 60° | linear scanning: 3.5MHz probe 104mm | ||
| 5MHz probe 61mm | |||
| convex sector scanning probe: sector | |||
| angle 60° | |||
| transmitting | |||
| voltage | pulse height 130V | pulse height 130V | |
| transmitting | |||
| pulse width | 3.5MHz pulse width 160 μs | 3.5MHz pulse width 140 μs | |
| 5MHz pulse width 100 μs | |||
| detecting | |||
| depth | 3.5MHz probe maximum depth: 210mm | 3.5MHz probe maximum depth: 210mm | |
| 5MHz probe maximum depth: 140mm | |||
| zoom | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0 | ||
| selectable as well as depth shift | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0 | ||
| selectable as well as depth shift | |||
| 5MHz probe: x1.0, x1.5, x2.0 | |||
| selectable as well as depth shift | |||
| frame rate | the maximum is 40 frame/second | the maximum is 40 frame/second | |
| grey scale | 16 | 16 | |
| memory | 512x512x4 bit | 512x512x4 bit | |
| coordinate | |||
| transformation | |||
| function | monitor can display electronic | ||
| linear scanning image or convex | |||
| sector scanning image | monitor can display electronic | ||
| linear scanning image or convex | |||
| sector scanning image | |||
| Performance | CTS-285 (portable) (SIUI) | EUB-310A (HITACHI) | |
| main | |||
| unit | video output | PAL or NTSC system TV signal | |
| (confirmed in order) | PAL or NTSC system TV signal | ||
| (confirmed in order) | |||
| power supply | 100V, 110V, 117V, 200V, 220V or | ||
| 234V, ±10%, 50/60Hz, about 140W | 100V, 110V, 117V, 200V, 220V or | ||
| 234V, ±10%, 50/60Hz, about 250W | |||
| monitor | 5.5" black and white monitor | 5.5" and 8" black and white monitor | |
| volume and | |||
| weight | 280(W)x235(H)x415(L)mm | ||
| approx. 13kg | 405(W)x710(1)x1310(H)mm | ||
| approx. 40kg | |||
| cursor shift | by trackball on keyboard | by joystick on keyboard | |
| electric | |||
| apparatus | |||
| safty | |||
| standard | conform ot requirement of I class | ||
| B type apparatus of IEC 601-1 | |||
| isolate resistor testing: testing | |||
| voltage 1000V L-L, L-G>10MΩ | |||
| leakage current: U-G10MΩ | |||
| leakage current: U-G |