(15 days)
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No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging modes and measurement accuracy.
No
The device is described as a "digital ultrasonic diagnostic B/W system" and its intended use is for "ultrasound diagnostic examination," indicating it is used for imaging and diagnosis, not treatment.
Yes
The device is described as an "ultrasonic diagnostic B/W system" used for "ultrasound diagnostic examination" of various body parts. It performs imaging of the human body for diagnostic purposes.
No
The device description explicitly states that the standard configuration includes a "Main unit, probes, relative accessories," indicating it is a hardware system with software components, not a software-only device.
Based on the provided information, the CHISON 8300 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CHISON 8300 is an ultrasound system that uses sound waves to create images of internal body structures. It does not analyze biological samples.
- The intended use and device description clearly state that it is a diagnostic ultrasound system for imaging and fluid flow analysis of the human body. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass/outside the body) diagnostics.
Therefore, the CHISON 8300 falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.
Product codes
IYO, ITX
Device Description
Display mode: B, B/B, 4B, B/M, M. In the B or M mode, 128 frames of real-time image can be stored in Cine-memory. The Standard configuration of the applicant device includes Main unit, probes, relative accessories, please see the Figure IV-1 ~ Figure IV-6 in Chapter IV Device Description for the pictures of the device. There's no unique feature or technological characteristics for the applicant device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasonic
Anatomical Site
abdomen, obstetric, gynecology, cardiology and small parts, Fetal, Pediatric, Small Organ (thyroid, parathyroid, parotid, submaxillary gland, and Breast), Cardiac, Transvaginal, Peripheral Vascular
Indicated Patient Age Range
adult, pregnant woman, pediatrics
Intended User / Care Setting
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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)
Effectiveness:
Accuracy Test was conducted for the effectiveness:
- Table 1 Measurement accuracy of CHISON-C60613S at 3.5MHz:
- Axial Distance:
§ 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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510(k) Summary
AUG 2 4 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510{k} Number is:
1. Applicant Device Information
Device Trade/Proprietary Name: CHISON 8300 Digital Ultrasonic Diagnostic Imaging System Device Common Name: Ultrasonic Imaging System and Transducers Device Classification Name: Ultrasonic Pulsed echo Imaging System
& Diagnostic Ultrasonic Transducer
Review Category: Tier II Product Code: IYO and ITX Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Device Class: II Prescription Status: Prescription Device
Establishment Registration Number: 3004753388
Owner/operator Number: 9066279
Intended Use:
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.
Submitter Information
Manufacturer Name:
CHISON MEDICAL IMAGING CO., LTD. No.8 Xiangnan Road, Shuofang, New District, Wuxi, China 214142 Establishment Registration Number: 3004753388 Owner/operator Number: 9066279
Contact Person of the Submission: Ms. Ruoli Mo; Ms. Karen Xie
COMPANY CONFIDENTIAL
X-1
1
Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a page number or document identifier. The text includes "K072210" on the first line, followed by "pg 2 of 4" on the second line. The handwriting is somewhat rough, but the characters are generally legible.
Display mode: B, B/B, 4B, B/M, M. In the B or M mode, 128 frames of real-time image can be stored in Cine-memory.
The Standard configuration of the applicant device includes Main unit, probes, relative accessories, please see the Figure IV-1 ~ Figure IV-6 in Chapter IV Device Description for the pictures of the device.
There's no unique feature or technological characteristics for the applicant device.
The accessories are listed as following tables:
| Part Name | Model | Application |
|---|---|---|
| Video Printer | SONY or Mitsubishi video | |
| printer | Print video image | |
| Trolley | TR-8000 | Carry 8300 and its accessories |
The Applicant Probe type:
| Probe Model | Type | Frequency | Application | Track |
|---|---|---|---|---|
| C60613S | Convex | 3.5 MHz | Abdomen Probe | 1 |
| L40617S | Liner Probe | 7.5 MHz | Superficial Probe | 1 |
| C12616S | Micro-convex | 6.0 MHz | Transvaginal Probe | 1 |
2
5. Effectiveness and Safety Considerations
Effectiveness:
· Accuracy Test was conducted for the effectiveness:
The following Table 1, Table 2 and Table 3 display the measurement accuracy of different type transducers using with CHISON 8300.
| Measurement | Unit | Range of availability | Accuracy |
|---|---|---|---|
| Axial Distance | mm | Full Screen (30~240mm) |