(239 days)
Not Found
No
The summary mentions "advanced digital imaging process" and "effective image analysis and diagnosis in real time," but it does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description focuses on the hardware and general digital processing capabilities, not on specific AI/ML algorithms for image analysis or diagnosis.
No
The device is described as an imaging system used for diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry."
No
The device description explicitly states it is a "dual X-ray machine" and mentions "separately embedded panorama and CT sensors," indicating it includes significant hardware components beyond just software.
Based on the provided information, the PaX-Zenith3D is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used in vitro (outside the body).
- PaX-Zenith3D Function: The PaX-Zenith3D is an X-ray system that takes images of the oral and craniofacial anatomy in vivo (inside the body). It uses radiation to create images, not to analyze biological specimens.
- Intended Use: The intended use clearly states it's for taking images of the oral and craniofacial anatomy and providing diagnostic information based on those images. This is a function of medical imaging, not IVD testing.
Therefore, the PaX-Zenith3D falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Computed Tomography (CT), panoramic X-ray
Anatomical Site
oral and craniofacial anatomy
Indicated Patient Age Range
children and adults
Intended User / Care Setting
x-ray technicians and dentists including oral surgeons
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)
Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. All test results were satisfactory.
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.
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
§ 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
MAR 2 5 2011
510(k) Summary (Revised)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
November 22, 2010
Manufacturer
VATECH Co., Ltd. 23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea
Tel: +82-31-379-9622 Fax: +82-31-379-9587 Contact person: Mr. Hyuk-jun Choi
United States Sales Representative (U.S. Designated agent)
VATECH America Inc. 333 Meadowlands Parkway #303, Secaucus, NJ 07094, USA Tel: +832-623-2099 Fax: +713-464-8880 Contact person: Mr. Dave Kim
Trade/Proprietary Name: PaX-Zenith3D
Computed Tomography X-ray System Common Name:
Classification Name:
System, X-ray, Tomography, Computed (21CFR 892.1750, Product code OAS, Class2)
Description:
PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.
Indication for use:
PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.
Vatech Co.,Ltd.
p. 1 of 2
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Predicate Device:
| Manufacturer | : E-WOO Technology Co., Ltd. |
|---|---|
| Device | : Picasso-Duo |
| 510(k) Number : K090991 (Decision Date - 10/9/2009) |
Substantial Equivalence:
PaX-Zenith3D described in this 510(k) has the similar intended use and technical characteristics as the Picasso-Duo of E-WOO Technology Co., Ltd.
The indications for use, material, form factor, performance, and safety characteristics between PaX-Zenith3D and the predicate device are similar. The primary differences are size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Zenith3D to the predicate device.
The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively, Further technical details of the pixel binning for S7199-01 is described in the Executive Summary (Tab 10).
The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison. Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well.
Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A)+A2, 1995), IEC 606061-1-1(2001), IEC 60601-1-3(Ed.1, 2006), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed.1, 1993), IEC 60601-2-32 (Ed.3, 2007) and IEC 60601-2-44 (Ed.2+A1, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
All test results were satisfactory.
PaX-Zenith3D also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. VATECH Co., Ltd. concludes that PaX-Zenith3D is safe and effective and substantially equivalent to predicate device as described herein.
END
Vatech Co.,Ltd.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094
MAR 2 5 2511
Re: K102196
Trade/Device Name: PaX-Zenith3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 8, 2010 Received: March 16, 2010
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known):
Device Name: PaX-Zenith3D
Classification: Computed Tomography X-ray System
Indications for Use:
PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Mary Patil
510K.
Division of Radiological Device Division of Haulologicul Device Evaluation and Safety
He
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