(48 days)
EMP-2100 K081873
No
The device description lists several digital signal processing techniques (DSC, DBF, RDA, DRF, DFS, frame correlation) and image processing methods (Histogram, Color encode, GAMA, Image Smoothen), but none of these are inherently AI/ML technologies. There is no mention of AI, DNN, or ML in the provided text, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device is described as an "ultrasound scanning diagnostic equipment" intended for "diagnostic ultrasound imaging analysis" and does not mention any therapeutic capabilities or functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound imaging analysis."
No
The device description explicitly states it is "high resolution linear/convex ultrasound scanning diagnostic equipment" and mentions hardware components like "digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), etc.", indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "diagnostic ultrasound imaging analysis" and "diagnostic ultrasound scanning." This involves generating images of internal structures of the body using ultrasound waves.
- Device Description: The description focuses on the technical aspects of ultrasound imaging, such as digital scan conversion, beam-forming, and image processing techniques.
- Input Imaging Modality: The input modality is explicitly stated as "Ultrasound."
- Anatomical Site: The anatomical sites listed are internal body parts and structures.
- Mechanism of Action: Ultrasound devices work by emitting sound waves into the body and detecting the reflected echoes to create images. This is a physical imaging process, not a chemical or biological test performed on samples taken from the body.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They perform tests in vitro (outside the body).
This device is an in vivo diagnostic imaging device, meaning it performs diagnostic procedures in vivo (within the living body).
N/A
Intended Use / Indications for Use
WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology, small-parts.
The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
Product codes
IYO, ITX
Device Description
This equipment is high resolution linear/convex ultrasound scanning diagnostic equipment. It adopts micro-computer control and digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), real time dynamic receiving apodization, real time dynamic receiving focusing (DRF), Digital frequency scan (DFS), frame correlation technologies to endue its image with clarity, stability and high resolution.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdomen, gynecology, obstetric, urology, small-parts, fetal, abdominal, pediatric, small organs, peripheral vascular, musculo-skeletal
Indicated Patient Age Range
adult, pregnant woman, pediatric and neonate
Intended User / Care Setting
Prescription device intended to be used by or on the order of a physician or similar qualified health care professional. Not intended for home use.
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)
Clinical Measurement Effectiveness Test was conducted on the subject device to evaluate its measurement accuracy.
Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications.
The proposed device has tested according with the clinical measurement accuracy report, UD2 Acoustic Output report for the effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Error = 1mm & Vertical >= 1mm
Resolution (mm):
Lateral:
§ 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.
0
KLOOO79
Section 3 510(k) Summary
As required by 807.97
"
. .
. ..
MAR - 1 2010
The assigned 510(k) Number is ________________________________________________________________________________________________________________________________________________
| Sponsor | Shenzhen Well.D Medical Electronics Co., Ltd.
13/F & 12/F North, New Energy Bldg, Nanhai Ave,
Nanshan District, Shenzhen 518054, China |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mr. Ning Bai, General Manager |
| | Tel:+86-755-26073352 |
| | Fax: +86-755-26073356 |
| | Email: Weld-2000@163.com |
| Submission
Correspondent | Mr. Tarzan Wang / Ms. Diana Hong
Shanghai Mid-Link Business Consulting Co., Ltd
Sute 5D, No. 19, Lane 999, Zhongshan No.2 Road(S)
Shanghai, 200030, China
Tel: +86-21-64264467
Fax: +86-21-64264467 ext. 809
Email: tarzan.wang@mid-link.net |
| Preparing Date: | Sept. 28, 2009 |
| Proposed Product | |
| Trade Name | Digital Ultrasound Scanner |
| Model | WED-3100 |
| Product Code: | IYO & ITX |
| Regulation Number: | 21 CFR 892.1560 & 21 CFR 892.1570 |
| Device Class: | Class II |
| Submission Purpose: | New Device |
| Predicate Device: | EMP-2100 Full Digital Ultrasound Diagnostic Device
K081873
Manufactured by: Shenzhen Emperor Electronic Technology
Co., Ltd. |
| Device Description | This equipment is high resolution linear/convex ultrasound
scanning diagnostic equipment. It adopts micro-computer
control and digital scan converter (DSC), digital |
| | beam-forming (DBF), real time dynamic aperture (RDA),
real time dynamic receiving apodization, real time dynamic
receiving focusing (DRF), Digital frequency scan (DFS),
frame correlation technologies to endue its image with
clarity, stability and high resolution. |
| Test Conclusion | Laboratory testing was conducted to validate and verify that
the proposed devices met all design specifications, including
electrical safety, EMC, specifications. |
| Intended
Use/Indication for Use | WED-3100 Digital Ultrasound Scanner is intended for diagnostic
ultrasound imaging analysis for abdomen, gynecology, obstetric,
urology, small-parts.
The system is intended to use for the following type of studies: fetal,
abdominal, pediatric, small organs, peripheral vascular, and
musculo-skeletal (both conventional and superficial). The device is
intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the
order of a physician or similar qualified health care professional. This
device is not intended for home use. |
1
Technology Characteristics
.
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.
.
| Model | WED-3100 |
|---|---|
| Monitor size | 5 inch |
| Display mode | B, B+B, B+M, M, 4B |
| Image gray scale | 256 |
| Image storage | 128 |
| Cine loop | ≥400 frame |
| Scan depth | 80 mm~220 mm |
| Image flip | Up/down, left/right |
| Focus position | Adjustable |
| posture mark | 40 |
| Image Process | Histogram, Color encode, GAMA, Image Smoothen |
| Frame correlation | Adjustable |
Table 3-1 WED-3100 basic technical specifications
3-2
・
2
·
· ···· ·
| Measurement | Distance, circumference, area, volume, heart rate. GA,FW,EDD |
|---|---|
| Notation | Date, time, name, sex, age, hospital name、Full screen words edit |
| output report | Measurement, Obstetric |
| Battery Continuous work | ≥3Hours |
| Size | L(230mm)*W(120mm)*H(38mm) |
| Net weight | 700g |
| Accuracy | Error ≤ ±10% |
| Measurement Range | Horizontal ≥ 1mm & Vertical ≥ 1mm |
- Tabel 3-2 Probe Technical Specification
| Probe Mode | C1-11/50R/3.5MHz | L1-5/7.5MHz |
|---|---|---|
| Nominal Frequency | convex array probe | high-frequency linear array probe |
| Type | ||
| Scan angle/width | 70.4° | 40mm |
| Number of Element | 80 | 80 |
| Size of Element | 0.765mm x 16.3mm | 0.5mm x 11 mm |
| Spacing of Element | 0.765mm | 0.5mm |
| Size | 62.4mm×16.30mm | 47.00mm×11.00mm |
| Maximum number of active elements of single pulse | 16 | 16 |
| Scan Depth | 80mm~220mm | 40mm~90mm |
| Array dimensions | 62.4mm x 16.3mm | 47.0mm x 11.0mm |
| Dead Zone (mm) | ≤3 | ≤6 |
| Detect Depth(mm) | ≥80 | ≥140 |
| Resolution (mm) | Lateral | |
| ≤1 (Depth≤60) | ≤3 (depth≤80) | |
| ≤5 (80 |