(46 days)
Not Found
No
The summary describes a standard digital X-ray system for dental imaging and does not mention any AI or ML capabilities, image processing beyond basic acquisition, or details about training/test sets typically associated with AI/ML development.
No
This device is an imaging system designed to acquire diagnostic information, not to administer therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to provide diagnostic information".
No
The device description explicitly states it is a "digital extra oral source x-ray system" and a "dental digital radiographic imaging system" equipped with "four dedicated sensors" for different X-ray modalities. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the PCH-2500 (PaX-i) is a digital extra oral source x-ray system used to take images of the oral and maxillofacial anatomy directly from the patient. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device is an imaging system. Its primary function is to capture radiographic images for diagnostic information, which is a characteristic of medical imaging devices, not IVDs.
Therefore, the PCH-2500 (PaX-i) falls under the category of a medical imaging device, specifically a dental digital radiographic imaging system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
Product codes
MUH, MQB
Device Description
PCH-2500 (PaX-i) is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-(PaX-i) can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), one cephalometric scan type (Xmaru2301CF) and two flat panel one shot ceph sensors (1210SGA and 910SGA).
PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
oral and maxillofacial anatomy
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
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
§ 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.
0
K122/55
Special 510(k) Summary
SEP 4 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.
Date
7/13/2012
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. Sung-Hee Park
Official Correspondent (U.S. Designated agent)
Dave Kim / 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:
PCH-2500 (PaX-i)
Common Name:
Digital X-ray Imaging System
Classification Name:
System, X-Ray, Extra oral Source, Digital (21CFR 872.1800, Product code MUH, class2)
1
Description:
PCH-2500 (PaX-i) is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-(PaX-i) can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), one cephalometric scan type (Xmaru2301CF) and two flat panel one shot ceph sensors (1210SGA and 910SGA).
PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
Indication for use:
PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
Predicate Device:
| Manufacturer | : Vatech Co., Ltd |
|---|---|
| Device | : PCH-2500 |
| 510(k) Number | : K113672 (Decision Date - 3/27/2012) |
Substantial Equivalence:
PCH-2500 (PaX-i) described in this special 510(k) submission has the same indications for use and similar technical characteristics as PCH-2500 (K113672) of Vatech Co., Ltd.
| Characteristic | Proposed
Vatech Co., Ltd.
PCH-2500 (PaX-i) | Predicate
Vatech Co., Ltd.
PCH-2500 |
|----------------|--------------------------------------------------|-------------------------------------------|
| 510(k) number | - | K113672, dated on 3/27/2012 |
| Indications | PCH-2500 (PaX-i) is a digital | PCH-2500 is a digital extra |
2
510(k) Submission -- PaX-i
.
| for use | extra oral source x-ray system
intended to take panoramic and
cephalometric images of the
oral and maxillofacial anatomy
to provide diagnostic
information for adult and
pediatric patients. The device
should be operated and used by
dentists, x-ray technicians and
other professionals licensed by
the law of the state in which
the device is used. | oral source x-ray system
intended to take panoramic and
cephalometric images of the
oral and maxillofacial anatomy
to provide diagnostic
information for adult and
pediatric patients. The device
should be operated and used by
dentists, x-ray technicians and
other professionals licensed by
the law of the state in which
the device is used. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Specification | Panoramic and cephalometric | Panoramic and cephalometric |
| Input Voltage | AC 100-120 / 200-240 V | AC 100-120 / 200-240 V |
| Tube Voltage | 50-90 kV | 50-90 kV |
| Tube Current | 4-10 mA | 4-10 mA |
| Focal Spot Size | 0.5 mm | 0.5 mm |
| Exposure Time | Max 20.2 s | Max 20.2 s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| | Xmaru1501CF panoramic
sensor : 5 lp/mm | Xmaru1501CF panoramic
sensor : 5 lp/mm |
| | Xmaru2301CF
cephalometric (scan type) :
5 lp/mm | Xmaru2301CF
cephalometric (scan type) :
5 lp/mm |
| Pixel Resolution | 1210SGA
cephalometric (one shot type) :
3.9 lp/mm | 1210SGA
cephalometric (one shot type):
3.9 lp/mm |
| | 910SGA
cephalometric (one shot type) :
3.9 lp/mm | |
| Pixel Size | Xmaru1501CF panoramic | Xmaru1501CF panoramic |
| | sensor : 100 x 100 μm | sensor : 100 x 100 μm |
| | Xmaru2301CF cephalometric
(scan type): | Xmaru2301CF cephalometric
(scan type): |
| | 100 x 100 μm | 100 x 100 μm |
| | 1210SGA
cephalometric (one shot type) :
127 x 127 μm | 1210SGA
cephalometric (one shot type) :
127 x 127 μm |
| | 910SGA
cephalometric (one shot type) :
127 x 127 μm | |
| Image Receptor | CMOS photodiode array –
panoramic (Xmaru1501CF) &
cephalometric (Xmaru2301CF) | CMOS photodiode array –
panoramic (Xmaru1501CF) &
cephalometric (Xmaru2301CF) |
| | Amorphous silicon TFT with
scintillator – Cephalometric
(1210SGA, 910SGA) | Amorphous silicon TFT with
scintillator – Cephalometric
(1210SGA) |
| | | |
| | | |
| | | |
.
.
3
510(k) Submission - PaX-i
Indications for use, safety characteristics, and non-clinical performance for panoramic and cephalometric sensors of PCH-2500 (PaX-i) and PCH-2500 are identical. The primary differences are as follows: PCH-2500 (PaX-i) offers a new solid state X-ray sensor for cephalometric mode: 910SGA. The non-clinical performance and clinical consideration report for the new SSXI detector, 910SGA, 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, we can claim the substantial equivalence of PCH-2500 (PaX-i) in comparison with its predicate device, PCH-2500, in terms of safety and effectiveness.
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,
4
- and IEC 60601-2-32 (Ed. 1, 1994) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.
PCH-2500 (PaX-i) also 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 PCH-2500 (PaX-i) is safe and effective and substantially equivalent to predicate device as described herein.
END
r
5
Image /page/5/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human profiles or flowing lines. The emblem is positioned to the right of the seal.
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
SEP
4 2012
Vatech Co., Ltd. % Mr. Dave Kim, MBA Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K122155
Trade/Device Name: PCH-2500 (PaX-i) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MQB Dated: August 21, 2012 Received: August 23, 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter ' requirements as be form inrketing your device as described in your Section 510(k) premarket with anow you to begall marketing your antial equivalence of your device to a legally marketed nonfleate 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 11 you desire specific and root of Jour 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 I va may other generers, 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
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):
): K/22/55 K/22/55
Device Name: PCH-2500 (PaX-i)
Classification: System, X-Ray, Extraoral Source, Digital (21 CFR 872.1800, Product code MUH, Class2)
Indications for Use:
PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and x-ray technicians and other professionals licensed by the law of the state in which the device is used.
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
6122155
Concurrence of CDRH, Office of Device Evaluation(ODE)
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