(148 days)
1417PGA
No
The summary describes a digital X-ray detector and its performance characteristics, focusing on image acquisition and processing for general radiography. There is no mention of AI, ML, or any algorithms that perform analysis or interpretation of the images beyond basic processing for display.
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is described as "designed for general radiographic system for human anatomy" and "intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." It explicitly mentions that the RAW files it generates "can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis." This indicates its role in acquiring images used for diagnosis.
No
The device description clearly states it is a "wired/wireless digital X-ray flat panel detector" and describes physical components like a scintillator and a-Si TFT sensor, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy." This describes an imaging device used on the human body, not a test performed on samples taken from the human body.
- Device Description: The description details an X-ray flat panel detector that acquires images of human anatomy. This aligns with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is an in-vivo diagnostic imaging device, specifically an X-ray detector.
N/A
Intended Use / Indications for Use
1417WGA 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
MQB
Device Description
1417WGA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN(IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WGA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
Mentions image processing
Yes
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
The non-clinical test report contains the MTF, DQE and NPS test results of 1417WGA and 1417PGA by using the identical test equipment and same analysis method described by IEC 6220-1. The comparison of the MTF for 1417WGA and 1417PGA detector demonstrated that the MTF of the 1417WGA detector performed almost same with 1417PGA. Therefore the overall resolution performance and sharpness of 1417WGA is almost same with 1417PGA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WGA demonstrated almost same DQE performance with 1417PGA at various spatial frequencies and provides almost same Signal-to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. 1417WGA exhibited NPS which has almost same performance with 1417PGA. Therefore, the image quality of 1417WGA is almost same with 1417PGA 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 (1417WGA) and control group (1417PGA) are evaluated according to similar age group and anatomical structures were compared in accordance with the test protocol of diagnostic radiography evaluation procedure.
Key Metrics
At the lowest spatial frequency, the 1417WGA has a DQE: of 41% and that of 1417PGA is 42%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K131114
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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 807.92.
Date 510K summary prepared: April 19, 2013
7 2013
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | 1F, 2F, 3F, #402, 14, Samsung 1-ro 1-gil, |
| Hwaseong-si, Gyeonggi-do, Korea | |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / Manager |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated agent) | |
| 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: | 1417WGA |
|---|---|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR892.1680 / Stationary x-ray system |
| Product Code: | MQB |
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Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : 1417PGA |
| 510(k) Number | : K122928 (Decision Date - JAN. 30. 2013) |
Device Description :
1417WGA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN(IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WGA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
Indication for use :
1417WGA 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.
Summary of the technological characteristics of the device compared to the predicate device:
The 1417WGA SSXI detector described in this 510(k) has the same indications for use and same technical characteristics as its predicate device. 1417GA flat panel detector, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1417WGA and 1417GA. the predicate device.
2
·
| Characteristic | Proposed
Rayence Co.,Ltd.
1417WGA | Predicate
Rayence Co.,Ltd.
1417PGA |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | -K122928 |
| Intended Use | 1417WGA 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. | 1417PGA 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. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Gadolinium Oxysulfide | Gadolinium Oxysulfide |
| Imaging Area | 14 x 17 inches | 14 x 17 inches |
| Total Pixel
Number | 3328 x 2816 pixels | 3328 x 2816 pixels |
| Pixel pitch | 127 um | 127 um |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 14 bit | 14 bit |
| Preview Image | 23 seconds (wired)5 seconds (wireless) | 2~3 seconds |
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| 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 | 460 x 417 x 15.9 mm |
| Weight | 3.6 kg (incl. battery pack) | 3.4 kg |
| Application | Wireless portable system
Available with upright stand,
table, universal stand | Portable system
Available with upright stand,
table, universal stand |
| Feature | Image: portable system | Image: portable system |
Table I: Comparison of 1417WGA and 1417PGA
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.
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510(k) Submission - 1417WGA
Table 2: Size Comparison of 1417WGA and 1417PGA
| Item | Unit | 1417WGA | 1417PGA |
|---|---|---|---|
| Pixel Pitch | μm | 127 x 127 | 127 x 127 |
| Total Pixel Number | pixels | 3328 x 2816 | 3328 x 2816 |
| Effective Pixel Area | mm | 415 x 350 | 415 x 350 |
| Effective Pixel Number(light | |||
| sensitive) | pixels | 3268x 2756 | 3268x 2756 |
| Fill factor | % | 61.03 | 61.03 |
| Weight | Kg | 3.6 Kg | 3.4 Kg |
Summary of Performance Testing:
The wireless/wired 1417WGA flat panel detector is a modified version of 1417PGA (K122928), FDA cleared predicate device from Rayence. Indications for use, material, form factor, performance, and safety characteristics between 1417WGA and 1417PGA are the same. 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 1417WGA and 1417PGA by using the identical test equipment and same analysis method described by IEC 6220-1 The comparison of the MTF for 1417WGA and 1417PGA detector demonstrated that the MTF of the 1417WGA detector performed almost same with 1417PGA. Therefore the overall resolution performance and sharpness of 1417WGA is almost same with 1417PGA. The DQE represents the ability to visualize object details of a certain size and contrast. 1417WGA demonstrated almost same DQE
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Image /page/4/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K131114" and below that is "Page 5 of 5". In the bottom left corner, the text "Rev.0" is visible. The handwriting appears to be cursive and the overall image has a simple, document-like quality.
performance with 1417PGA at various spatial frequencies and provides almost same 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, the 1417WGA has a DQE: of 41% and that of 1417PGA is 42%. 1417WGA exhibited NPS which has almost same performance with 1417PGA. Therefore, the image quality of 1417WGA is almost same with 1417PGA 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 (1417WGA) and control group (1417PGA) are evaluated according to similar 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 test and the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 1417WGA and its predicate device, 1417PGA in terms of image quality.
Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical electrical equipment Part 1: General Requirements for Safety) was performed, and EMC testing were conducted in accordance with standard IEC60601-1-2:2007 (CISPR 11:2009/A1: 2010), EN60601-1-2:2007 +A1:2010 (Medical electrical equipment - Part 1-2: General Requirements for safety -- Collateral Standard : Electromagnetic Compatibility Requirements and tests). The equipment also complies with the standard FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB. 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 1417WGA is safe and effective and substantially equivalent in comparison with 1417PGA, , the predicate device as described herein.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September, 17, 2013
Ravence Co. Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K131114
Trade/Device Name: Digital Flat Panel X-ray Detector/1417WGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 30, 2013 Received: September 4, 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 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.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K131114
Digital Flat Panel X-Ray Detector /1417WGA Device Name:
Indications for Use:
1417WGA 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 (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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Flealth
K131114 510(k)
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