(132 days)
Not Found
No
The summary describes a digital X-ray detector and its performance characteristics, focusing on image acquisition, processing into standard formats (DICOM), and image quality metrics (MTF, DQE, NPS). There is no mention of AI, ML, deep learning, or any algorithms that perform analysis or interpretation beyond basic image processing for display. The clinical evaluation involves a radiologist's expert opinion, not an automated AI/ML analysis.
No
The device is described as an X-ray detector intended for diagnostic imaging to provide a case diagnosis and treatment planning. It is not used for treatment.
Yes
The "Intended Use / Indications for Use" states that the device provides "a case diagnosis and treatment planning for physicians and other health care professionals," which is a diagnostic purpose. The "Device Description" also mentions "radiographic image diagnosis and analysis."
No
The device description explicitly states it is a "wired/wireless digital X-ray flat panel detector" and describes its physical components (scintillator, a-Si TFT sensor), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 1012WCA Digital Flat Panel X-Ray Detector is a medical imaging device. It captures radiographic images of the human anatomy using X-rays. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for human anatomy" and "intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning". This describes an imaging function, not an in vitro diagnostic test.
The device is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
1012WCA 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. 1012WCA 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and other health care professionals.
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 contains the MTF, DQE and NPS test results of 1012WCA and Xmaru1210P by using the identical test equipment and same analysis method described by IEC 62220-1 The comparison of the MTF for 1012WCA and Xmaru1210P detector demonstrated that the MTF of the Xmaru1210P detector performed better than 1012WCA. Nevertheless the overall resolution performance and sharpness of 1012WCA is better than Xmaru1210P 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. 1012WCA demonstrated better DQE performance than Xmaru1210P 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. The reduced noise has improved the accuracy of image and reduced the degree of artifacts for the new detector. Also, the image quality of 1012WCA is greater than Xmaru1210P 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 (1012WCA) and control group (Xmaru1210P) 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 comparisons for both devices, we can claim equivalent or better diagnostic image quality of the 1012WCA flat panel detector compared to the predicate device, Xmaru1210P.
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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K123345
Page 1 of 6
MAR 1 2 2013
Special 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: October 22, 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 Iro 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: | 1012WCA |
|---|---|
| Common Name: | Digital Flat Panel X-ray Detector |
| Classification Name : | 21CFR 892.1680, Stationary X-ray System, |
| Solid State X-ray Imaging Device, Class2 | |
| Product Code: | MQB |
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K123345
Page 2 of 6
Predicate Device :
| Manufacturer | : Rayence Co., Ltd. |
|---|---|
| Device | : Xmaru1210P |
| 510(k) Number | : K101590 (Decision Date - NOV 29. 2010) |
Device Description :
1012WCA 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. 1012WCA 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 :
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Summary of the technological characteristics of the device compared to the predicate device:
The 1012WCA SSXI detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, Xmaru1210P flat panel detector, of Rayence Co., Ltd. Table 1 summarizes the technological characteristics of the 1012WCA and Xmaru1210P, the predicate device.
2
K123345
Page 3 of 6
.
:
:
| Characteristic | Proposed
Rayence Co., Ltd.
1012WCA | Predicate
Rayence Co.,Ltd.
Xmaru1210P |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | - | K101590 |
| Intended Use | 1012WCA Digital Flat
Panel X-Ray Detector is
indicated for digital imaging
solution designed for human
anatomy including head,
neck, cervical spine, arm, leg
and peripheral (foot, hand,
wrist, fingers, etc.).
It is intended to replace film
based radiographic
diagnostic systems and
provide a case diagnosis and
treatment planning for
physicians and other health
care professionals. Not to be
used for mammography. | Xmaru1210P Digital Flat
Panel X-Ray Detector is
indicated for digital imaging
solution designed for human
anatomy including head,
neck, spinal column, arm, leg
and peripheral (foot, hand,
wrist, fingers, etc.).
It is intended to replace film
based radiographic
diagnostic systems and
provide a case diagnosis and
treatment planning for
physicians and other health
care professionals. Not to be
used for mammography. |
| Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT |
| Scintillator | Cesium Iodide | Cesium Iodide |
| Imaging Area | 11 x 13 inches | 11 x 13 inches |
| Pixel matrix | 2080 x 2560 (5.3 million) | 2080 x 2560 ( 5.3 million) |
| Pixel pitch | 127 µm | 127 µm |
| Resolution | 3.9 lp/mm | 3.9 lp/mm |
| A/D conversion | 16 bit | 14 bit |
| Grayscale | 65536(16bit) | 16384 (14bit) |
Table 1· Co mparison of 1012WCA and Yr מחוריו
:
.
3
K123345
Page 4 of 6
ាន
510(k) Submission - 1012WCA
1
| Preview Image | 3 seconds | 6.5 seconds |
|---|---|---|
| Data output | DICOM 3.0 compatible Print | |
| Management Service | ||
| Class(SCU), Storage Service | ||
| Class(SCU), and others | ||
| DICOM Patient CD | ||
| DICOM Basic Print | DICOM 3.0 compatible Print | |
| Management Service | ||
| Class(SCU), Storage Service | ||
| Class(SCU), and others | ||
| DICOM Patient CD | ||
| DICOM Basic Print | ||
| Dimensions | 395 x 337 x 18 mm | 422 x 403 x 22 mm |
| Weight | 3.15 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: black box | Image: white box |
Table 2: Size Comparison of 1012WCA and Xmaru1210P
| Item | Unit | 1012WCA | Xmaru1210P |
|---|---|---|---|
| Pixel size | μm | 127 x 127 | 127 x 127 |
| Total horizontal and | |||
| vertical size | mm | 264 x 325 | 264 x 325 |
| Total horizontal and | |||
| vertical element count | pixels | 2080 x 2560 | 2080 x 2560 |
| Active area horizontal | |||
| and vertical size | mm | 259 x 320 | 259 x 320 |
| Active area horizontal | |||
| and vertical element | |||
| count | pixels | 2040 x 2520 | 2040 x 2520 |
| Pixel spacing | um | 127 | 127 |
| Fill factor | % | 65.14 | 65.14 |
| Weight | Kg | 3.15 Kg | 3.4 Kg |
4
Summary of Performance Testing:
The wireless/wired 1012WCA flat panel detector is a modified version of Xmarul210P, FDA cleared under the document number K101590. Indications for use, material, form factor, performance, and safety characteristics between 1012WCA and Xmaru1210P, the predicate device 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 1012WCA and Xmaru1210P by using the identical test equipment and same analysis method described by IEC 62220-1 The comparison of the MTF for 1012WCA and Xmaru1210P detector demonstrated that the MTF of the Xmaru1210P detector performed better than 1012WCA. Nevertheless the overall resolution performance and sharpness of 1012WCA is better than Xmaru1210P 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. 1012WCA demonstrated better DQE performance than Xmaru1210P 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. The reduced noise has improved the accuracy of image and reduced the degree of artifacts for the new detector. Also, the image quality of 1012WCA is greater than Xmaru1210P 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 (1012WCA) and control group (Xmaru1210P) 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 comparisons for both devices, we can claim equivalent or better diagnostic image quality of the 1012WCA flat panel detector compared to the predicate device, Xmaru1210P.
5
510(k) Submission - 1012WCA
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 IEC 60601-2 (Medical electrical equipment Part 2: General Requirements for safety - Collateral Standard : Electromagnetic Compatibility Requirements and tests). FCC part 15 subpart B and C, Class A.
All test results were satisfactory.
Conclusions :
The performance data demonstrates that the 1012WCA SSXI detector is as safe and effective as its predicate device, Xmaru1210P. Based on the information in this submission, similarity to the predicate device, and the results of our design control activities, it is our opinion that the 1012WCA flat panel detector is substantially equivalent to the predicate device, Xmaru1210P.
6
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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
Rayence Co. Ltd. C/O Dave Kim Mtech Group 12946 Kimberley Lane HOUSTON TX 77079
Re: K123345
Trade/Device Name: Digital Flat Panel X-Ray Detector/1012WCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 8, 2013 Received: February 11, 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. Iisting 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.
7
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/McdicalDevices/Safetv/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,
Sm.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K123345
Digital Flat Panel X-ray Detector/1012WCA Device Name:
Indications for Use:
1012WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. 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)
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(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123345 510(k)
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