(192 days)
Not Found
No
The description focuses on standard digital imaging processing and reconstruction techniques, not explicitly mentioning AI or ML. The absence of terms like "AI," "ML," "deep learning," or descriptions of training/test sets for such algorithms further supports this conclusion.
No
The device is described as a diagnostic imaging system, used for acquiring images and diagnostic information for treatment planning, not for providing therapy or treatment itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "provides diagnostic details of the anatomic structures" and the "Device Description" section refers to it as a "diagnostic imaging system."
No
The device description explicitly states it is a "diagnostic imaging system which consists of multiple image acquisition modes" and is "equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography." This indicates significant hardware components beyond just software.
Based on the provided information, the PaX-Flex3D 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.
- PaX-Flex3D Function: The PaX-Flex3D is an imaging system that uses X-rays to create images of the oral and maxillofacial anatomy. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for producing images for diagnostic details and treatment planning based on the structure of the oral anatomy, not on the analysis of biological markers.
- Device Description: The description focuses on the imaging technology (X-ray, CMOS detector) and the types of images produced (panoramic, cephalometric, CT).
Therefore, the PaX-Flex3D falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.
Product codes
OAS, JAK
Device Description
PaX-Flex3D is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography for implantation. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D is equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography.
The computed tomography is a system based on CMOS digital X-ray detector. CMOS CT detector is used to capture scanned images in 3D for obtaining diagnostic information of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral anatomy, oral and maxillofacial area
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
physicians, dentists, and x-ray technicians.
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 (A1+A2, 1995), 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 60601-2044 (Ed.2+A1, 2002) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. 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
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
FEB 1 8 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
July 29, 2010
Manufacturer
Vatech Co., Ltd.
23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic
Tel: +82-31-679-2081
Fax: +82-31-379-9587
Contact person: Mr. Choi Hyuk-jun
United States Sales Representative (U.S. Designated agent)
VATECH America.
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-Flex3D
Common Name:
Dental Computed Tomography X-ray System
Classification Name:
X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2)
Description:
1
PaX-Flex3D is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography for implantation. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D is equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography.
The computed tomography is a system based on CMOS digital X-ray detector. CMOS CT detector is used to capture scanned images in 3D for obtaining diagnostic information of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.
Indication for use:
PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentishy, The device is operated and used by physicians, dentists, and x-ray technicians.
Predicate Device:
| Manufacturer | : E-WOO Technology Co., Ltd. |
|---|---|
| Device | : PaX-Reve3D |
| 510(k) Number | : K090171 (Decision Date - 4/30/2009) |
Substantial Equivalence:
The PaX-Flex3D described in this 510(k) has the same intended use and similar technical characteristics as PaX-Reve3D of E-WOO Technology Co., Ltd.
| Characteristic | Proposed
Vatech Co., Ltd.
PaX-Flex3D | Predicate
E-WOO Technology Co., Ltd.
PaX-Reve3D |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K090171 |
| Indications
for use | PaX-Flex3D is a computed
tomography x-ray system intended to
produce panoramic,
cephalometric or cross-sectional
images of the oral anatomy on a real
time basis by computer
reconstruction of x-ray image data
from the same axial plane taken at
different angles. It provides
diagnostic details of the anatomic
structures by acquiring 360°
rotational image sequences of oral
and maxillofacial area for a precise
treatment planning in adult and
pediatric dentistry. The device is
operated and used by physicians,
dentists, and x-ray technicians. | PaX-Reve3D is Computed
Tomography X-Ray System.
Real time - image acquisition.
Especially, advanced digital
imaging process allows
considerably efficient diagnosis,
all kind of information
management, real-time sharing of
image information on network.
Furthermore PaX-Reve3D is
equipped with the Flat Panel
Detector, CT sensor to capture a
3D X-ray Computed tomography
scanned image. |
| Performance
Specification | Panoramic, cephalometric and computed
tomography | Panoramic, cephalometric and
computed tomography |
| Input Voltage | 110V/230V~ | 110V/220V~ |
| Tube Voltage | 50-90 kV | 40-90kV |
| Tube Current | 4~10 mA | 2-10mA |
| Focal Spot Size | 0.5 mm | 0.5mm |
| Exposure Time | 9 - 24 s | 0.5s-30s (Various) |
| Size of Imaging
Volume | 8 x 5 cm | 14 x 12 cm |
| | 5 x 5 cm | 10 x 6 cm |
| | | 5x5 cm |
| Slice Width | 0.1mm min. | 0.1mm min. |
| Total Filtration | 2.8mmAl | 2.8mmAl |
| | 3.3 lp/mm - CT | 2.5 lp/mm - CT |
| Pixel
Resolution | 5 lp/mm - Panorama | 4.5 lp/mm - Panorama |
| | 5 lp/mm - Cephalometric | 3.94 lp/mm - Cephalometric |
| | 150 x 150 μm / 200 x 200 μm - CT | 200 μm - CT |
| Pixel Size | 100 x 100 μm - Panorama | 96 μm - Panorama |
| | 100 x 100 μm - Cephalometric | 127 μm - Cephalometric |
| Image Receptor | CT with Flat Panel Detector | CT with Flat Panel Detector |
| Chin Rest | Equipped Headrest | Equipped Headrest |
| Performance
Specification | Computed tomography | Computed tomography |
| Mechanical | Compact design | Compact design |
| Electrical | LDCP logic circuit | LDCP logic circuit |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical
Sites | Maxillofacial | Maxillofacial |
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510(k) Submission - PaX-Flex3D
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510(k) Submission - PaX-Flex3D
The indications for use, material, form factor, performance, and safety characteristics between PaX-Flex3D and the predicate device are the same. The primary difference is size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Flex3D to the predicate device.
Safety, EMC and Performance Data:
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), 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 60601-2044 (Ed.2+A1, 2002) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
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-Flex3D is safe and effective and substantially equivalent to predicate device as described herein.
END
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes on its wings, symbolizing health, hope, and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Vatech Co., Ltd. c/o Mr. Dave Kim Medical Device Regulatory Affairs Vatech America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094
FFB 18 201
Re: K102259
Trade Name: PaX-Flex3D Regulation Number: 21 CFR § 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 11, 2011 Received: February 15, 2011
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
5
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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 S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(K) Number (if known):
Device Name: PaX-Flex3D
Classification: Dental Computed tomography X-ray system
Indications for Use:
PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.
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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
K102259
510K
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