(28 days)
Not Found
No
The summary describes standard computer reconstruction of x-ray data, which is a common technique in medical imaging and does not inherently imply the use of AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an x-ray imaging system intended for diagnostic purposes, specifically for acquiring images of oral and maxillofacial anatomy for precise treatment planning. It does not mention any therapeutic function.
Yes
The device "provides diagnostic details of the anatomic structures" and its images are used for "precise treatment planning". It is also stated that the "CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy."
No
The device description explicitly states it is a "complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector" and a "dental CBCT system is based on CMOS digital X-ray detector." These are hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The PaX-Flex3D is an X-ray imaging system. It produces images of the oral anatomy within the body using X-rays. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to produce images for diagnostic details of anatomical structures for treatment planning. This is a form of in vivo (within the living body) diagnostic imaging.
Therefore, the function and intended use of the PaX-Flex3D clearly fall outside the definition of 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
Device Description
PaX-Flex3D (PHT-7000), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D (PHT-7000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental Computed Tomography X-ray System
Anatomical Site
oral anatomy, oral and maxillofacial area
Indicated Patient Age Range
adult and pediatric dentistry
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)
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 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
Special 510(k) Summary
. This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
5/2/2012
Manufacturer
Vatech Co., Ltd.
23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic
Tel: +82-31-379-9585 Fax: +82-31-379-9638 Contact person: Mr. Sonny Park
Official Correspondent (U.S. Designated agent)
Mtech Group
12946 Kimberley Ln, Houston, TX 77079
Tel: +713-467-2607
Fax: +713-464-8880
Contact person: Mr. Dave Kim (davekim@mtech-inc.net)
Trade/Proprietary Name:
PaX-Flex3D (PHT-7000)
Common Name:
Dental Computed Tomography X-ray System
Classification Name:
X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2)
1
Description:
PaX-Flex3D (PHT-7000), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D (PHT-7000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric 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 dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.
Predicate Device:
| Manufacturer | : Vatech Co., Ltd |
|---|---|
| Device | : PaX-Flex-3D |
| 510(k) Number | : K102259 (Decision Date – 2/18/2011) |
Substantial Equivalence:
PaX-Flex3D (PHT-7000) described in this 510(k) has the similar intended use and technical characteristics as PaX-Flex3D of Vatech Co., Ltd.
| Characteristic | Proposed
Vatech Co., Ltd.
PaX-Flex3D (PHT-7000) | Predicate
Vatech Co., Ltd.
PaX-Flex3D |
| ---------------- | ------------------------------------------------------- | --------------------------------------------- |
|---|
2
510(k) Submission – PaX-Flex3D (PHT-7000)
.
..
| 510(k) number | K121412 | K102259 |
|---|---|---|
| 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-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. | ||
| Performance | ||
| Specification | Panoramic, cephalometric and computed | |
| tomography | Panoramic, cephalometric and | |
| computed tomography | ||
| Input Voltage | AC 100-120/200-240 V | AC 110/230 V |
| Tube Voltage | 50-90 kV | 50-90 kV |
| Tube Current | $2 \sim 10$ mA | $4 \sim 10$ mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | $1.9 - 24$ s | $9 - 24$ s |
| Slice Width | 0.1 mm min. | 0.1 mm min. |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| 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 |
| Image Receptor | Computed | |
| Tomography | ||
| (Flat Panel Detector) | ||
| Xmaru0712CF | ||
| Xmaru1215CF Plus | Xmaru0808CF |
:
·
Vatech Co., Ltd.
:
·
.
.
.
3
510(k) Submission – PaX-Flex3D (PHT-7000)
| | | Panoramic
(CMOS photodiode
array) | Xmaru1501CF | Xmaru1501CF |
|---------------------------|------|-------------------------------------------------|-----------------------------------------------------|---------------------|
| | | Cephalo
Metric
(CMOS photodiode
array) | Xmaru2301CF | Xmaru2301CF |
| Size of Imaging
Volume | | Xmaru0712CF | 5 x 5 cm / 8 x 5 cm / 8 x 8 cm | - |
| | | Xmaru1215CF Plus | 5 x 5 cm / 8 x 5 cm /
8.5 x 8.5 cm / 12 x 8.5 cm | - |
| | | Xmaru0808CF | - | 5 x 5 cm / 8 x 5 cm |
| Pixel
Resolution | CT | Xmaru0712CF | 3.5 lp/mm | - |
| | CT | Xmaru1215CF Plus | 3.5 lp/mm | - |
| | | Xmaru0808CF | - | 3 lp/mm |
| | Pano | Xmaru1501CF | 5 lp/mm | 5 lp/mm |
| | Ceph | Xmaru2301CF | 5 lp/mm | 5 lp/mm |
| Pixel Size | | Xmaru
0712CF | 140 x 140 μm | - |
| | CT | Xmaru
1215CF
Plus | 140 x 140 μm | - |
| | | Xmaru
0808CF | - | 150 x 150 μm |
| | Pano | Xmaru
1501CF | 100 x 100 μm | 100 x 100 μm |
| | Ceph | Xmaru
2301CF | 100 x 100 μm | 100 x 100 μm |
Indications for use, safety characteristics, and non-clinical performance for panoramic, cephalometric and CBCT sensors of PaX-Flex3D (PHT-7000) and PaX-Flex3D are similar. The primary differences are as follows: PaX-Flex3D (PHT-7000) introduces two new cone beam CT sensors:
Vatech Co., Ltd.
4
510(k) Submission - PaX-Flex3D (PHT-7000)
Xmaru0712CF and Xmaru1215CF Plus. The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Flex3D (PHT-7000) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D, 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 60601-1-1 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
PaX-Flex3D (PHT-7000) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 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 (PHT-7000) is safe and effective and substantially equivalent to predicate device as described herein.
END
Vatech Co., Ltd.
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
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 Official correspondent (U.S. designated agent) Mtech group 12946 Kimberly Lane HOUSTON TX 77079
JUN - 8 2012
Re: K121412
Trade/Device Name: PaX-Flex3D (PHT-7000) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 11, 2012 Received: May 11, 2012
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 (reporting of
6
Enclosure
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 requirences as 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
7
Indications for Use
510(K) Number (if known):
Device Name: PaX-Flex3D (PHT-7000)
Classification: 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)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K
Concurrence of CDRH, Office of Device Evaluation(ODE)