(48 days)
Not Found
No
The document describes a standard digital X-ray system with image processing, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "digital panoramic dental X-ray imaging system" intended for "producing diagnostic X-ray radiographic images," indicating its use for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for producing diagnostic X-ray radiographic images." The "Device Description" also refers to it as "PaX-Primo diagnostic equipment."
No
The device description explicitly lists hardware components such as an X-ray generator, X-ray controller, X-ray beam limiting device, image process unit, exposure switch, and CMOS digital sensor. This indicates it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- PaX-Primo's Function: The description clearly states that PaX-Primo is a digital panoramic dental X-ray imaging system. It uses X-rays to create images of the patient's skull, dentition, and oral structures directly on the patient. It does not involve the analysis of specimens taken from the body.
Therefore, PaX-Primo falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
PaX-Primo is a digital panoramic dental X-ray imaging system that uses a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral smictures of the patient population targeting men. women and children. The device is operated and used by physicians. dentists and X-ray technologists.
Product codes (comma separated list FDA assigned to the subject device)
MUH, EHD, and MQB
Device Description
PaX-Primo diagnostic equipment is a dental panoramic X-ray system which consists of X-ray generator, X-ray controller, X-ray beam limiting device, image process unit and exposure switch. This device utilizes a high voltage generator to generate X-ray by inputting energy to the anode and the cathode. The X-ray is exposed on the oral maxillofacial area of a patient before reaching CMOS digital sensor. The CMOS sensor converts resulting X-ray into clectrical charge. The clectrical pattern is further converted to voltage and a digital signal which is interpreted by a computer to produce a digital image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, dentition, and oral structures
Indicated Patient Age Range
men, women and children
Intended User / Care Setting
physicians, dentists and X-ray technologists.
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, and IEC 60601-2-32 was 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" was 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
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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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
January 18, 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)
E-WOO Technology USA Inc. 256 North Sam Houston Pkwy E. #115, Houston, TX 77060, USA
Tel: +281-598-8124 Fax: +281-598-8150 Contact person: Mr. Dave Kim
Trade/Proprietary Name:
PaX-Primo
Common Name:
Digital X-ray Imaging System
Classification Name:
System, X-ray, Extraoral Source, Digital (21CFR 872.1800, Product code MUH, Class2)
Vatech Co., Ltd.
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Description:
PaX-Primo diagnostic equipment is a dental panoramic X-ray system which consists of X-ray generator, X-ray controller, X-ray beam limiting device, image process unit and exposure switch. This device utilizes a high voltage generator to generate X-ray by inputting energy to the anode and the cathode. The X-ray is exposed on the oral maxillofacial area of a patient before reaching CMOS digital sensor. The CMOS sensor converts resulting X-ray into clectrical charge. The clectrical pattern is further converted to voltage and a digital signal which is interpreted by a computer to produce a digital image.
Indication for use:
PaX-Primo is a digital panoramic dental X-ray Imaging system that uses a CMOS detector for real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists and X-ray technologists.
Predicate Device:
| Manufacturer | : Vatech Co., Ltd. |
|---|---|
| Device | : PaX-P&P |
| 510(k) Number | : K073365 (Decision Date - Apr. 8. 2008) |
Substantial Equivalence:
The PaX-Primo described in this 510(k) has the same intended use and similar technical characteristics as the PaX-P&P of Vatech Co., Ltd.
| Characteristic | Proposed
Vatech Co., Ltd.
PaX-Primo | Predicate
Vatech Co., Ltd.
PaX-P&P |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K073365 |
| Indications for use | PaX-Primo is a digital panoramic
dental X-ray Imaging system that uses
a CMOS detector for real time digital
image acquisition. It is intended for
producing diagnostic X-ray
radiographic images of skull, dentition,
and oral structures. The device is
operated and used by physicians. | PaX-P&P is a digital x-ray system that
uses a high resolution CCD detector for
real time digital image acquisition.
The system allows lower radiation dose,
simple use interface, and produces high
quality images. It is intended for
producing diagnostic X-ray
radiographic images of skull, dentition, |
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| | dentists and X-ray technologists. | and orla structures. The device is
operated and used by physicians,
dentists,a nd x-ray technologist. |
|------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------|
| Performance
Specification | Panoramic | Panoramic |
| Power source | 110V/230V~, 50/60Hz | 110V/230V~, 50/60Hz |
| X-ray tube | D-051 (Toshiba) | D-051 (Toshiba) |
| Focal spot size | 0.5 mm | 0.5 mm |
| Total filtration | 2.8 mm Al | 2.8 mm Al |
| Tube voltage | 50 – 80 kVp | 50 – 80 kVp |
| Tube current | 2 – 10 mA | 2 - 10 mA |
| Nominal
magnification | 1.3 | 1.3 |
| Exposure time | Min. 6.5 sec
Max. 13.5 sec | Min. 6.6 sec
Max. 13.2 sec |
| DICOM
compatibility | Compatible | Compatible |
| X-ray beam | Fan beam | Fan beam |
| Pixel size | 0.100 mm | 0.096 mm |
| Active area | 150.4x6 mm | 146x6 mm |
The indications for use, material, form factor, performance, and safety characteristics between PaX-Primo and the predicate device are the same. The primary difference is cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Primo to the predicate device.
Safety, EMC and Performance Data:
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, and IEC 60601-2-32 was 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" was performed.
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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-Primo is safe and effective and substantially equivalent to predicate device as described herein.
END
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Image /page/4/Picture/0 description: The image shows a logo with two distinct parts. On the left, there's a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle. To the right of this emblem, the letters "DEP" are printed in a bold, sans-serif font.
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 1 2013
VATECH Co., Ltd. % Mr. Dave Kim Product Compliance Officer E-WOO Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060
Re: K100317
Trade/Device Name: System, X-Ray, Extraoral Source, Digital Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: February 3, 2010 Received: February 4, 2010
Dear Mr. Kim:
This letter corrects our substantially equivalent letter of March 24, 2010.
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. Iisting 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
5
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,
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
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Indications for Use
510(k) Number(if known):
Device Name: Pax-Primo
Classification: System, X-Ray, Extraoral Source, Digital
Indications for Use:
PaX-Primo is a digital panoramic dental X-ray imaging system that uses a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral smictures of the patient population targeting men. women and children. The device is operated and used by physicians. dentists and X-ray technologists.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ AND/OR (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)
Office of In Vitro
510K K10r317
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