CTS-200 WITH EZU-PL21 TRANSDUCER

• K Number: K963068
• Device Name: CTS-200 WITH EZU-PL21 TRANSDUCER
• Manufacturer: SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
• Date Cleared: 1997-05-29 ( 295 days)
• Product Code: IYO
• Regulation Number: 892.1560

Intended Use

Diagnostic ultrasound imaging of the human body as follows: Fetal, Abdominal, Cardiac Adult. Mode of Operation: B mode for Fetal and Abdominal, M mode for Cardiac Adult.

Device Description

Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed 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, 9inch video monitor and a special photographic unit.

Predicate Devices

K862164

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with basic imaging modes and features, with no mention of AI, ML, or advanced image processing techniques typically associated with such technologies.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging" system, and its intended use is for "Diagnostic ultrasound imaging of the human body". There is no mention of treating or preventing diseases or conditions.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging of the human body." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "compact-type linear electronic scanning ultrasound system" with a "main unit" that is "portable and is separable from other equipment," indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, 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.
• Device Function: The description clearly states that this device is an ultrasound system used for imaging the human body. It uses ultrasonic waves to create images of internal structures (fetal, abdominal, cardiac).
• Mode of Operation: The modes (B mode, M mode) are standard ultrasound imaging modes.
• Lack of Sample Analysis: There is no mention of analyzing biological samples or performing any tests on substances taken from the body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Diagnostic ultrasound imaging MXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX of the human body as follows:

Clinical Application: Fetal (B Mode), Abdominal (B Mode), Cardiac Adult (M Mode)

Product codes (comma separated list FDA assigned to the subject device)

90 IYO, 90 ITX

Device Description

Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed 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, 9inch video monitor and a special photographic unit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo Imaging System

Anatomical Site

Fetal, Abdominal, Cardiac Adult

Indicated Patient Age Range

Adult, Fetal

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Hitachi Medical Corporation EUB-240, K862164

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

K763068

Image /page/0/Picture/1 description: The image shows the word "SIUI" in a bold, textured font. The letters are large and take up most of the frame. The texture of the letters gives them a slightly rough or distressed appearance.

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MAY 2 9 1997

Premarket Notification [510(k)] Summarv

July 30, 1996 (revised 5/6/97)

Trade Name: CTS-200 with EZU-PL21 Transducer

Common Name: Diagnostic Ultrasound System

SHANTOU INSTITUTE C

Ultrasonic Pulsed Echo Imaging System, 90 IYO Classification Name: (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

Fax: [phone] Telephone: [phone]

Hitachi Medical Corporation EUB-240, K862164 Predicate:

Device Description: Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed 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, 9inch video monitor and a special photographic unit.

Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal and abdominal imaging and adult cardiac M-mode.

Technological Characteristics: See the attached "Comparison List" of the SIUI CTS-200 and the Hitachi EUB-240.

御蔵 家居TEL: [phone] 感 誕生4K [phone]

1

COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

1 2 3 3 1 3

		Performance	CIS-200 (portable) (SIUI)	EUB-240 (HITACHI)
	main
uni t	scanning mode	electronic linear scanning (compa-
tible 64 elements linear probe)	electronic linear scanning (compa-
tible 64 elements linear probe)
		display mode	B mode, B/B mode, M mode, B/M mode
simutaneous ly	B mode, B/B mode, M mode, B/M mode
simutaneously
in B mode display: distance, area
and circumference
in M mode display: time interval,
velocity and heart rate
area, circumference, volume, heart
rate and pregnant weeks
4-steps focusing with variable
aperture and lens focusing
		measurement	in B mode display: distance, area
and circumference
in M mode display: time interval,
velocity and heart rate.
		caculation	area, circumference, volume, heart
rate and pregnant weeks
		focusing mode	4-steps focusing with variable
aperture and lens focusing
		scanning width	3. 5MHz probe: 102mm	3.5MHz probe: 102mm
5 MHz probe: 56mm
		transmitting
voltage	pulse height 120V	pulse height 120V
		transmitting
pulse width	3.5MHz pulse width 190 us	3.5MHz pulse width 190 us
5MHz pulse width 144 u s
		detecting
depth	3.5MHz maximum depth: 200mm	3. 5MHz maximum depth: 200mm
5MHz maximum depth: 180mm
		ZOOD
magnification	11.0, x1.5, x2.0 selectable as
well as depth shift	x1.0, x1.5, x2.0 selectable as
well as depth shift
		frame rate	the maximum is 25 frame/second	the maximum is 25 frame/second
		grey scale	16	16
		memory	256x512x4 bit	256x512x4 bit
		video output	PAL or NTSC system TV signal
(confirmed in order)	PAL or NTSC system TV signal
(comfirmed in order)
		power supply	100V, 110V, 117V, 200V, 220V or
234V, ±10%, 50/60Hz, about 140W	110V, 117V, 200V, 220V or
100V.
±10%, 50/60Hz, about 140W
234V,
		monitor	9" black and white monitor	9" black and white monitor
		volume and
weight	280 (w) x235 (1) x415 (h) mm
approx.
13kg	400 (w) x720 (1) x1290 (h) mm
approx. 65kg
		cursor shift	by 9 cursor shift keys t , 1 . - .
-. / . . / . \ and FAST	by 9 cursor shift keys t , 1 , - ,
+, / , , / , \ and FAST

:

2

Performance	CTS-200 (portable) (SIUI)	EUB-240 (HITACHI)
main electric
unit apparatus
safty
standard	conform to 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