(110 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard imaging technology and reconstruction.
No
The device is described as a diagnostic x-ray system intended to produce images for dental examination and diagnosis; it does not mention any therapeutic function.
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 a "complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector," indicating it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The PaX-Uni3D is an X-ray imaging system. It produces images of the teeth, jaw, and oral structure by passing X-rays through the patient's body and capturing the resulting transmission data. This is an in vivo (within the body) diagnostic method.
- Intended Use: The intended use clearly states it's for producing images for "dental examination and diagnosis of diseases of the teeth, jaw and oral structure." This is achieved through imaging, not through testing bodily samples.
The device is a diagnostic imaging system, 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
PaX-Uni3D (PHT-7500), 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-Uni3D (PHT-7500) 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
computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed tomography x-ray, panoramic x-ray, cephalometric x-ray
Anatomical Site
teeth, jaw, oral structure, Maxillofacial
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(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-Uni3D (PHT-7500) 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "K121400". The characters are written in a simple, slightly messy style, with varying stroke thicknesses. The image is in black and white, with the characters standing out against the white background.
Special 510(k) Summary
AUG 2 8 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
May 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: Park Sung-Hee
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-Uni3D (PHT-7500)
Common Name: .
Digital X-ray Imaging System
Classification Name:
System, X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2)
1
Description:
PaX-Uni3D (PHT-7500), 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-Uni3D (PHT-7500) 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:
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.
Predicate Device:
| Manufacturer | : Vatech Co., Ltd |
|---|---|
| Device | : PaX-Uni3D |
| 510(k) Number | : K090467 (Decision Date -- Jan. 8, 2010) |
Substantial Equivalence:
PaX-Uni3D (PHT-7500) described in this 510(k) has the similar intended use and technical characteristics as PaX-Uni3D of Vatech Co., Ltd.
2
510(k) Submission – PaX-Uni3D (PHT-7500)
| Characteristic | Proposed
Vatech Co., Ltd.
PaX-Uni3D (PHT-7500) | Predicate
Vatech Co., Ltd.
PaX-Uni3D |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K090467 |
| 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. | 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. |
| 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 | 40-90 kV |
| Tube Current | 210 mA | 210 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max 20.2s (Pano)
15s/24s selectable (CT)
0.9-1.2s (Ceph) | 0.5-12.7s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Performance
Specification | Dental Computed tomography | Dental Computed tomography |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Anatomical
Sites | Maxillofacial | Maxillofacial |
. ·
:
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| Characteristic of detector | | | Proposed
PaX-Uni3D (PHT-7500) | Predicate
PaX-Uni3D |
|----------------------------|------------------------------------------------------|--------------------------|----------------------------------------------------|------------------------|
| Image Receptor | Computed
Tomography
(CMOS photodiode
array) | | Xmaru0712CF | |
| | Panoramic
(CMOS photodiode
array) | | Xmaru1215CF Plus | Xmaru0808CF |
| | Cephalometric
(Flat Panel Detector) | | Xmaru1501CF | S7199-01 |
| Size of Imaging
Volume | | | 1210SGA | Xmaru1210 |
| | 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 | - |
| | | Xmaru1215CF Plus | 3.5 lp/mm | - |
| | | Xmaru0808CF | - | 3.3 lp/mm |
| | Pano | Xmaru1501CF | 5 lp/mm | - |
| | | S7199-01 | - | 10.43 lp/mm |
| | Ceph | 1210SGA (FDA
K113630) | 3.9 lp/mm | - |
| | | Xmaru1210 | - | 3.9 lp/mm |
| Pixel Size | CT | Xmaru0712CF | 140 x 140 μm | - |
| | | Xmaru1215CF Plus | 140 x 140 μm | - |
| | | Xmaru0808CF | - | 150 x 150 μm |
| | Pano | Xmaru1501CF | 100 x 100 μm | - |
| | | S7199-01 | - | 48 x 48 μm |
| | Ceph | 1210SGA (FDA
K113630) | 127 x 127 μm | - |
| | | Xmaru1210 | - | 127 x 127 μm |
510(k) Submission - PaX-Uni3D (PHT-7500)
The indications for use, material, form factor, performance, and safety characteristics between PaX-Uni3D (PHT-7500) and the predicate device are the same. The primary differences are as follows: PaX-Uni3D (PHT-7500) introduces four new SSXI sensors: Xmaru0712CF and Xmaru1215CF Plus for CT mode, 1210SGA for Cephalometric mode and Xmaru1,501CF for panoramic mode.
:
4
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-Uni3D (PHT-7500) is substantially equivalent, in terms of safety and effectiveness, with PaX-Uni3D, 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-Uni3D (PHT-7500) 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-Uni3D (PHT-7500) is safe and effective and substantially equivalent to predicate device as described herein.
END
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Image /page/5/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 design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the bird image.
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
· AUG 2 8 2012
Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K121400
Trade/Device Name: PaX-Uni3D (PHT-7500) Regulation Number: · 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 30, 2012 Received: August 1, 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
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mountal device related ad retor e vality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the quality as described in your Section 510(k) premarket motification. 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 If you ucare specific an 100 for your urro 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 Tou inal 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
Enclosure
7
Indications for Use
510(K) Number (if known):
Device Name: PaX-Uni3D (PHT-7500)
.
Classification: System, X-ray, Tomography, Computed, Dental
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.
Prescription Use_ (Part 21 CFR 801 Subpart D)
. Over-The-Counter Use AND/OR (P art 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 Division of Naciological Evaluation and Safety
K121460
510K
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