(319 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The description focuses on standard CT reconstruction and image acquisition.
No
The device is described as a "diagnostic x-ray system" intended for "dental examination and diagnosis of diseases." It produces images for diagnosis, not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure".
No
The device description explicitly states it is a "computed tomography x-ray system" and "diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system," indicating it includes hardware components for generating and capturing X-ray images. The performance studies also mention testing related to electrical, mechanical, and environmental safety, which are relevant to hardware.
Based on the provided information, the PaX-Uni3D is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the PaX-Uni3D is an X-ray system used to produce images of the teeth, jaw, and oral structure directly on the patient. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on imaging technology. The description details the use of a computed tomography sensor and digital X-ray imaging, which are characteristic of medical imaging devices, not IVDs.
Therefore, the PaX-Uni3D falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PaX-Uni3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Product codes
OAS
Device Description
The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw and oral structure
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)
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 892.1750.
Date: November 4, 2009
'JAN ~ 8 2010
- Company and Correspondent making the submission:
Name: Vatech Co., Ltd.
23-4, Seogu-Dong, Hwaseong-si, Gyeonggi-do, 445-170, Address: Korea
Telephone: +82-31-377-9104
Fax: +82-31-337-1882
Contact: Mr. DongTaek, Oh
- Internet: http://www.vatech.co.kr
-
- Device :
| Trade/proprietary name | : PaX-Uni3D |
|---|---|
| Common Name | : Digital X-ray imaging system |
| Classification Name | : X-ray, tomography, computed, dental |
-
- Predicate Device :
| Manufacturer | : Vatech Co., Ltd. |
|---|---|
| Device | : PaX-500 |
| 510(k) Number | : K082350 (Decision Date - Oct. 10. 2008) |
- Classifications Names & Citations :
21CFR 892.1750, OAS, X-ray, tomography, computed, dental, Class2
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5. Description :
5.1 General
The PaX-Uni3D diagnostic equipment consists of Digital Computed Tomography, Panoramic, and Cephalometric dental X-ray system. This device is a system based on Digital X-ray Imaging System (Computed Tomography Sensor to Capture X-ray Digital Computed Tomogram Scanned Image)
5.2 Product features
1). Condition of Input
·Rated input voltage: AC 220V
- ·Guaranteed working voltage
-110V Mode: 100 ~120V / 220V Mode: 200 ~240V
•Possible working voltage
-110V Mode : 90 ~130V / 220V Mode : 180 ~ 250V
·Rated input frequency: 50Hz/60Hz
•Insulation withstanding: below than 1.5KV cap for more than one minute
between first test and second test.
2) Capture mode
-
•Panoramic System
2-1 Standard Mode -
Standard Panoramic
-
V Hemi-Panoramic (Left and Right)
-
Frontal Dentition
-
V Sinus
-
TMJ open/Close mouth: 4 views
-
2-2 Special Mode
- Incisor clear >
- V Orthogonal
- V Canal clear
- Maxillary Molar clear
Vatech Co., Ltd.
2
Image /page/2/Picture/1 description: The image contains two dental x-rays, one labeled "Standard Panoramic" and the other labeled "Canal clear". The "Standard Panoramic" x-ray shows a full view of the teeth and jaw. The "Canal clear" x-ray shows a close-up view of a specific tooth or area of the mouth.
•Capture modes of Cephalometric System
- √ Latero-Lateral [Lateral Mode]
- V Posterior Anterior [PA Mode]
- / Carpus
- V SMV
Image /page/2/Picture/7 description: The image contains two X-ray images of a human skull. The image on the left shows a side view of the skull, while the image on the right shows a front view. The X-rays reveal the bone structure of the skull, including the cranium, facial bones, and teeth. The images are grayscale and have a grainy texture.
- Tomography
- √ Shooting Mode : Mandible/ Maxillary/ Occlusion/ TMJ
- √ Shooting Range : All kind of tooth
- ✔ Basic Display View : View Available
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