(105 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 features that typically utilize AI/ML, or performance studies related to AI/ML algorithms.
No
The device is an extraoral x-ray system intended for diagnostic imaging of oral and maxillofacial anatomy, not for treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is a "digital extra oral source x-ray system" and a "dental digital radiographic imaging system" that can be "equipped with three dedicated sensors." This indicates the device 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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The PCH-2500 is an X-ray system that takes images of the oral and maxillofacial anatomy. It works by using radiation to create images of internal structures.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body (like blood, tissue, or urine) in a laboratory setting. It directly images the patient's anatomy.
Therefore, based on the provided information, the PCH-2500 falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PCH-2500 is 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 (comma separated list FDA assigned to the subject device)
MUH, MOB
Device Description
PCH-2500 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-2500 can be equipped with three dedicated sensors, each for two X-ray modalities : panoramic (Xmarul 501CF), cephalometric scan type (Xmaru2301CF) and oneshot ceph sensor type (1210SGA).
PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging option based on the customer's 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 performance and clinical consideration report for the SSXI detector, 1210SGA, are provided separately in this submission.
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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K113672
Page 1 of 5
MAR 2 7 2012
510(k) Submission - PCH-2500
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
レ 12/8/2011
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:
PCH-2500
Common Name:
. Digital X-ray Imaging System
Classification Name:
System, X-Ray, Extra oral Source, Digital (21CFR 872.1800, Product code MUH, class2)
1
510(k) Submission - PCH-2500
Description:
PCH-2500 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-2500 can be equipped with three dedicated sensors, each for two X-ray modalities : panoramic (Xmarul 501CF), cephalometric scan type (Xmaru2301CF) and oneshot ceph sensor type (1210SGA).
PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging option based on the customer's diagnostic needs.
Indication for use:
PCH-2500 is 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 | : PaX-Flex3D |
| 510(k) Number | : K 102259 (Decision Date - 2/18/2011) |
Substantial Equivalence:
PCH-2500 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.
PCH-2500 | Predicate
Vatech Co., Ltd.
PaX-Flex3D |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K102259 |
| Indications
for use | PCH-2500 is digital extra oral
source x-ray system intended | PaX-Flex3D is a computed
tomography x-ray system intended to |
| | 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. | 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 and cephalometric | Panoramic and cephalometric
and compute tomography |
| Input Voltage | AC 100-120 / 200-240 V | AC 110 / 230 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 | 9-24 s |
| Total Filtration | 2.8 mmAl | 2.8 mmAl |
| Pixel Resolution | Panoramic : 5 lp/mm | Panoramic : 5 lp/mm |
| | Cephalometric (scan type)
5 lp/mm : | Cephalometric (scan type)
5 lp/mm : |
| | Cephalometric (one shot type)
3.9 lp/mm : | |
| | CT – N/A | CT - 3.3 lp/mm |
| Pixel Size | Panoramic : 100 x 100 µm | Panoramic - 100 x 100 µm |
| | Cephalometric (scan type):
100 x 100 µm : | Cephalometric (scan type):
100 x 100 µm : |
| Cephalometric (one shot type) | | |
| 127 x 127 µm : | | |
| | CT - N/A | CT : 150 x 150 µm/200 x 200 µm |
| Image Receptor | CMOS photodiode array –
panoramic (Xmaru1501CF) &
cephalometric
(Xmaru2301CF)
Amorphous silicon TFT with
scintillator – Cephalometric
(1210SGA) | CMOS photodiode array –
panoramic (Xmaru1501CF) &
cephalometric (Xmaru2301CF) |
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510(k) Submission – PCH-2500
:
. : .
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672
5
3
K 1111672
Page 4 of 5
510(k) Submission - PCH-2500
Indications for use, safety characteristics, and non-clinical performance for panoramic and cephalometric sensors (scan type) of PCH-2500 and PaX-Flex3D are similar. The primary differences are as follows: PCH-2500 lacks the cone beam CT mode. PCH-2500 offers optional solid state X-ray sensor for cephalometric mode. (The non-clinical performance and clinical consideration report for the SSXI detector, 1210SGA, 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 in comparison with PaX-Flex3D, the predicate device, 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, 1993) 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 also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.
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K1111672
Page 5 of 5
510(k) Submission - PCH-2500
Clinical considerations according to FDA Guidance Non-clinical & & "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 is safe and effective and substantially equivalent to predicate device as described herein.
END
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the eagle's feathers. The logo 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
MAR 2 7 2012
Vatech Co., Ltd. Mr. Dave Kim Official Correspondent Mtech Group 12946 Kimberly Lane HOUSTON TX 77079
Re: K113672
Trade/Device Name: PCH-2500 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MOB Dated: February 14, 2012 Received: February 16, 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
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mcuirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quarty, I device as described in your Section 510(k) premarket will anow you to begin marketing your covivalence of your device to a legally marketed nontication. The I Dr I mailing of succion 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 decire operitio da research 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 Tou may 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
KIN672
Indications for Use
510(k) Number(if known):
Device Name: PCH-2500
Classification: System, X-Ray, Extraoral Source, Digital (21 CFR 872.1800, Product code MUH, Class2)
Indications for Use:
PCH-2500 is 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)
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)
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K. K113672
Concurrence of CDRH, Office of Device Evaluation(ODE)
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