(99 days)
Not Found
No
The summary describes a digital X-ray detector and its image processing capabilities to generate DICOM files, but there is no mention of AI or ML being used for image analysis, diagnosis, or any other function. The performance studies focus on standard imaging metrics (MTF, DQE, NPS) and expert review of image quality, not AI/ML performance metrics.
No
The device is used for diagnostic imaging (creating X-ray images for diagnosis), not for treating or curing a medical condition.
Yes
The device is described as an "X-Ray Detector" intended for "digital imaging solution designed for general radiographic system for human anatomy." The "Intended Use" states it is "intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." Furthermore, the "Device Description" mentions that the generated files "can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW," indicating its role in diagnosis.
No
The device description explicitly states it is a "portable digital X-ray flat panel detector" which is a hardware component. While it includes software for image processing, it is not solely software.
No, 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 about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The 1417PCA Digital Flat Panel X-Ray Detector is used to capture X-ray images of the human anatomy directly on the patient. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy." This is a diagnostic imaging device, not an in vitro diagnostic device.
The device is a medical device used for diagnostic imaging, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
1417PCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
1417PCA is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images. 1417PCA is designed specifically to be integrated with an operating PC and a X-ray generator to digitalize X-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
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)
The non-clinical test report and clinical consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1417PCA and SDX-4336CP by using the identical test equipment and same analysis method described by IEC 6220-1. The comparison of the MTF for 1417PCA and SDX-4336CP detector demonstrated that the MTF of the 1417PCA detector performed better than SDX-4336CP. Therefore the overall resolution performance and sharpness of 1417PCA is better than SDX-4336CP which results improvement of the ability of the new detector to represent distinct anatomic features within the imaged object. The DQE represents the ability to visualize object details of a certain size and contrast. 1417PCA demonstrated better DQE performance than SDX-4336CP at various spatial frequencies and provides a higher Signal-to-Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, 1417PCA has a DQE of 55% and that of SDX-4336CP is 52%. The reduced noise has improved the accuracy of image and reduced the degree of artifacts for the new detector. 1417PCA exhibited NPS which has lower performance than SDX-4336CP. Therefore, the image quality of 1417PCA is greater than SDX-4336CP at the same patient exposure.
To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion. Both test (1417PCA) and control group (SDX-4336CP) are evaluated according to age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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K 122919
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510K summary prepared: September. 21, 2012
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | (Seogu-dong, 2F/4F) 14, Samsung 1ro 1-gil, |
| Hwaseong-si, Gyeonggi-do, 445-170, Korea | |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent: | |
| (U.S. Designated agent) | Dave Kim (davekim@mtech-inc.net) |
| Address: | 12946 Kimberley Ln, Houston, TX 77079 |
| Telephone: | +713-467-2607 |
| Fax: | +713-464-8880 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Trade/proprietary name: | 1417PCA |
|---|---|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | Solid State X-ray Imaging Device, Class2 |
| Regulation Number / Name: | 21CFR 892.1680 / Stationary X-ray system |
Rayence Co., Ltd.
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| Product Code: | MQB |
|---|---|
| Predicate Device : | |
| Manufacturer | : Samsung Mobile Display Co., Ltd. |
| Device | : SDX-4336CP |
| 510(k) Number | : K102321 (Decision Date - Feb. 11. 2011) |
Device Description :
1417PCA is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images. 1417PCA is designed specifically to be integrated with an operating PC and a X-ray generator to digitalize X-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.
Indication for use :
1417PCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
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Summary of the technological characteristics of the device compared to the predicate device:
1417PCA SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, SDX-4336CP, of Samsung Mobile Display Co., Ltd. Table 1 summarizes the technological characteristics of the 1417PCA and SDX-4336CP the predicate device.
| Characteristic | Proposed
Rayence Co.,Ltd.
1417PCA | Proposed
Samsung Mobile Display
Co., Ltd.
SDX-4336CP |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K102321 |
| Intended Use | 1417PCA Digital Flat Panel
X-Ray Detector is indicated
for digital imaging solution
designed for general
radiographic system for
human anatomy. It is
intended to replace film or
screen based radiographic
systems in all general
purpose diagnostic
procedures. Not to be used
for mammography. | SDX-4336CP Digital Flat Panel
X-Ray Detector is indicated for
digital imaging solution designed
for providing general
radiographic diagnosis of human
anatomy targeting both adult and
children. It is intended to be used
by physicians and radiologists
and not to be used for
mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Cesium Iodide | Cesium Iodide |
| Imaging Area | 14 x 17 inches | 14 x 17 inches |
| Pixel matrix | 3328 x 2816 (9.4 million) | 2880 x 2400 (6.9 million) |
| Pixel pitch | 127 um | 150 um |
| Resolution | 3.9lp/mm | 3.3lp/mm |
Table 1: Comparison of 1417PCA and SDX-4336CP
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| A/D conversion | 14 bit | 14 bit |
|---|---|---|
| Grayscale | 16384 (14bit) | 16384 (14bit) |
| Preview Image | 2~3 seconds | 2~3 seconds |
| Data output | RAW | |
| *The RAW files are | ||
| convertible into DICOM 3.0 | ||
| by console S/W | RAW | |
| *The RAW files are | ||
| convertible into DICOM 3.0 | ||
| by console S/W | ||
| Dimensions | 460 x 417 x 15.9 mm | 491 × 480 × 15 mm |
| Weight | 3.6 kg | 3.8 kg |
| Application | Portable system | |
| Available with upright stand, | ||
| table, universal stand | Portable system | |
| Available with upright stand, | ||
| table, universal stand | ||
| Feature | Image: black box with handle | Image: gray box |
Table 2: Comparison of 1417PCA and SDX-4336CP
| Item | Unit | 1417PCA | SDX-4336CP |
|---|---|---|---|
| Pixel size | μm | 127 x 127 | 150 x 150 |
| Total horizontal and vertical size | mm | 422.7 x 357.6 | 432 x 360 |
| Total horizontal and vertical element count | pixels | 3328 x 2816 | 2880 x 2400 |
| Active area horizontal and vertical size | mm | 416.6 x 351.8 | 423 x 351 |
| Active area horizontal and vertical element count | pixels | 3280 x 2770 | 2820 x 2340 |
| Pixel spacing | μm | 127 | 150 |
| Fill factor | % | 65.14 | 68.5 |
| Weight | Kg | 3.6 Kg | 3.8 Kg |
Rayence Co., Ltd.
4
Summary of Performance Testing:
Indications for use, material, form factor, performance, and safety characteristics between 1417PCA and the predicate device are very similar. The non-clinical test report and clinical . consideration report were prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors. The non-clinical test report contains the MTF, DQE and NPS test results of 1417PCA and SDX-4336CP by using the identical test equipment and same analysis method described by IEC 6220-1 The comparisoin of the MTF for 1417PCA and SDX-4336CP detector demonstated that the MTF of the 1417PCA detector performed better than SDX-4336CP. Therfore the overall resolution performance and shapness of 1417PCA is better than SDX-4336CP which results improvement of the ability of the new detector to represent distinct anatomic features whitin the imaged object. The DQE represents the ability to visualize object details of a certain size and contrast. 1417PCA demonstrated better DQE performance than SDX-4336CP at various spatial frequencies and provides a higher Signal-toNoise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, 1417PCA has a DQE of 55% and that of SDX-4336CP is 52%. The reduced noise has imporved the accuracy of image and reduced the degree of artifacts for the new detector. 1417PCA exhibited NPS which has lower performance than SDX-4336CP. Therefore, the image quality of 1417PCA is greater than SDX-4336CP at the same patient exposure.
To further demonstrate the substantial equivalency of two devices, clinical images are taken from both devcies and reviewd by a licensed US radiologist to render an expert opinion. Both test (1417PCA) and control group (SDX-4336CP) are evaluated according to age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.
Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisions for both devices, we can claim equivalent or better diagnostic image quality for1417PCA compared to the predicate device, SDX-4336CP.
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Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1998+A1:1999+A2:1995(Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard (Medical electrical equipment - Part 1-2: General Requirements for safety - Collateral Standard : Electromagnetic Compatibility Requirements and tests).
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.
Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rayence Co., Ltd. concludes that 1417PCA is safe and effective and substantially equivalent in comparison with the predicate device as described herein.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Ravence Co., LTD. C/O Mr. Dave Kim Medical Devices Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K122919
Trade/Device Name: Digital Flat Panel X-ray Detector 1417PCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 16, 2013 Received: January 28, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sean M. Boyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122919
Device Name: Digital Flat Panel X-Ray Detector /1417PCA
Indications for Use:
1417PCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K122919 510(k)
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