(27 days)
No
The description focuses on the hardware (detector technology) and basic image processing for DICOM conversion. There is no mention of AI/ML algorithms for image analysis, diagnosis, or other functions.
No.
The device is an X-ray detector used for diagnostic imaging, not for treating a disease or condition.
Yes
The device "is indicated for digital imaging solution designed for general radiographic system for human anatomy" and "is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures." It is explicitly stated that the device "can be utilized to capture and digitalize X-ray images for radiographic diagnosis."
No
The device description explicitly states it is a "digital solid state X-ray detector that is based on flat-panel technology" and describes its physical components (scintillator, amorphous silicon, etc.), indicating it is a hardware device.
Based on the provided information, the device 1717FCC 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 device used to examine specimens from the human body (which is the definition of an IVD).
- Device Description: The description details an X-ray detector that captures and digitalizes X-ray images. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the 1717FCC is a medical device used for diagnostic imaging in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
1717FCC 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, JAA
Device Description
1717FCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy (general radiographic system)
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 clinical and non-clinical test report for the subject device were prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device performance compared to the predicate device.
After comparing a broad review of plain radiographic images taken with 1717FCC and 1717SCC_140μm, images obtained with 1717FCC and 1717SCC were equivalent quality for the same view obtained from a similar patient with the 1717SCC 140μm. In general, both the spatial and soft tissue contrast resolution are slightly superior using the 1717FCC. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.
The non-clinical test report contains the MTF, DQE and NPS performance test comparison between the subject device (1717FCC), and the predicate device (1717SCC), by using the identical test equipment and same analysis method described by IEC 62220-1.
The MTF and DQE testing represent the ability to visualize object details of a certain size and contrast. 1717FCC demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1717SCC, the predicate device, at all spatial frequencies.
The frame rate and image resolution for 1717 FCC, the subject device, perform better than the specification of the reference device, DRF 4343 (K080859) which are referenced in K131766.
Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivaleny between the subject device and the predicate device in terms of diagnostic image quality.
Key Metrics
MTF, DQE, NPS
Predicate Device(s)
Reference Device(s)
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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April 28, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St., Suite 610 HOUSTON TX 77054
Re: K210985
Trade/Device Name: 1717FCC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: March 26, 2021 Received: April 1, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210985
Device Name 1717FCC
Indications for Use (Describe)
1717FCC 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K210985
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 16, 2021
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | Rayence Co., Ltd. |
|---|---|
| Submitter's Address: | 14, Samsung 1-ro 1-gil, Hwaseong-si, Gyeonggi-do, Korea |
| Submitter's Telephone: | +82-31-8015-6459 |
| Contact person: | Mr. Kee Dock Kim / RA Team Manager / +82-31-8015-6459 |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| Address: | 7505 Fannin St. Ste 610-V111, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
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 | : 1717FCC |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
| Product Code | : MQB, JAA |
Primary Predicate Device :
| Trade/Device Name | : 1717SCC_127μm and 1717SCC_140μm |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K171420 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
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| Product Code | : MQB |
|---|---|
| Reference Device: | |
| Trade/Device Name | : DRF 4343 (Pixium RF 4343) |
| 510(k) Number | : K080859 |
| Regulation Number | : 21 CFR 892.1650 |
| Regulation Name | : Image intensified Fluoroscopic X-ray system |
| Regulatory Class | : Class II |
| Product Code | : JAA and MQB |
2. Device Description
1717FCC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.
3. Indication for use
1717FCC is indicated for digital imaging solution designed for general radiographic system for human It is intended to replace film or screen based radiographic systems in all general purpose anatomy. diagnostic procedures. Not to be used for mammography.
4. Summary of Design Control Risk management
1717FCC digital X-ray detector is a modification of 1717SCC (K171420). 1717FCC was developed for the purpose of retrofitting the stationary X-ray system with a film detector.
The risks and the hazardous impact of the device modification were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design change were successfully mitigated and accepted.
5
5. Summary of the technological characteristics of the device compared to the predicate device:
1717FCC detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate devices, 1717SCC (K171420).
5.1 Scintillator layer
*scintillator layer. ( * scintillator : a phosphor that produces scintillations)
| Scintillator Type | Proposed | Predicate |
|---|---|---|
| CsI (Cesium Iodide) | 1717FCC | 1717SCC 127um and |
| 1717SCC 140um |
5.2 Power source
| | | Proposed
1717FCC | Predicate
1717SCC |
|-------|------------|----------------------------------------------------------------|---------------------------------------------------------|
| Power | Type | Power adapter | Power supply |
| | Model name | AHM85PS24 | RP003A |
| | Dimension | 150 X 64 X 37
(cable length: 900 mm) | 188 X 92 X 41.5 |
| | Weight | 0.4 | 0.5 |
| | Rating | Input: 100-240 V, 1.0 A, 50/60 Hz
Output: 24VDC (Max 3.54A) | Input: 100-240VAC (50/60Hz)
Output: 24VDC (Max 1.7A) |
5.3 Generator specifications
| Model | Manufacture | Specification | |||
|---|---|---|---|---|---|
| 32kW | 40kW | 50kW | |||
| CMP 200 | Communications & Power | ||||
| Industries | kVp | 40-125 | 40-150 | 40-150 | |
| mA | 10-400 | 10-500 | 10-630 | ||
| EDITOR HFe 501 | Rontgenwerk Bochum | kVp | 40-150 | ||
| mA | 10-630 | ||||
| UD150L-40E/40F | Shimadzu | kVp | 40-150 | ||
| mA | @100 kVp- 500(320) | ||||
| @80 kVp- 630(400) | |||||
| PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 | ||
| mA | 500 |
5.4 Comparison with the predicate device
| Characteristic | Proposed Device (K210985) | Predicate Device (K171420) |
|---|---|---|
| ---------------- | --------------------------- | ---------------------------- |
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| Manufacturer | Rayence Co.,Ltd. | Rayence Co.,Ltd. | ||||||
|---|---|---|---|---|---|---|---|---|
| Product Name | 1717FCC | 1717SCC | ||||||
| Feature | Image: 1717FCC | Image: 1717SCC | Similar | |||||
| Indications | ||||||||
| for use | 1717FCC 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. | 1717SCC_127um and | |||||||
| 1717SCC_140um, are 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. | Same | |||||||
| Detector Type | Amorphous Silicon (a-Si) TFT + PIN | |||||||
| type photodiode | ||||||||
| IGZO TFT + PIN type photodiode | ||||||||
| (option) | Amorphous Silicon (a-Si) TFT | Similar | ||||||
| Scintillator | CsI:Tl | 1717FCC | CsI:Tl | 1717SCC | Similar | |||
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Similar | |||||
| Pixel matrix | 140 type: 3000 x 3000 (Full resolution) | |||||||
| 280 type: 1500 x 1500 (2x2 binning) | ||||||||
| 420 type: 1000 x 1000 (3x3 binning) | ||||||||
| 560 type: 750 x 750 (4x4 binning) | 140 type : 3072 x 3072 | Similar | ||||||
| Pixel pitch | 140 μm / 280 μm/ 420 μm/ 560 μm | 140 μm | Similar | |||||
| A/D conversion | 14 / 16 bit | 14 bit / 16 bit | Same | |||||
| MTF | a-Si TFT | 1.0 lp/mm, Typ. 0.535 | ||||||
| 2.0 lp/mm, Typ. 0.220 | ||||||||
| 3.0 lp/mm, Typ. 0.099 | ||||||||
| 3.5 lp/mm, Typ. 0.073 | 1.0 lp/mm, Typ. 0.580 | |||||||
| 2.0 lp/mm, Typ. 0.283 | ||||||||
| 3.0 lp/mm, Typ. 0.158 | ||||||||
| 3.5 lp/mm, Typ. 0.120 | Similar | |||||||
| IGZO TFT | 1.0 lp/mm, Typ. 0.525 | |||||||
| 2.0 lp/mm, Typ. 0.209 | ||||||||
| 3.0 lp/mm, Typ. 0.092 | ||||||||
| 3.5 lp/mm, Typ. 0.064 | - | |||||||
| DQE (0) | a-Si TFT | Typ. 0.751 | 0 lp/mm, Typ. 0.740 | Similar | ||||
| IGZO TFT | Typ. 0.766 | - | ||||||
| Preview time | Image | |||||||
| resolution | Upto 3.5 lp/mm | Upto 3.4 lp/mm | Better |
8
6. Summary of Performance Testing
1717FCC Digital Flat Panel X-Ray Detector has the same indications for use, the same scintillator material (CsI:Tl ), the same generator specifications and the same risk analysis characteristics compared to 1717SCC, the predicate devices (K171420). The pixel matrix and pixel pitch sizes are different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.
The clinical and non-clinical test report for the subject device were prepared and submitted to FDA to demonstrate the substantial equivalency of the subject device performance compared to the predicate device.
After comparing a broad review of plain radiographic images taken with 1717FCC and 1717SCC_140μm, images obtained with 1717FCC and 1717SCC were equivalent quality for the same view obtained from a similar patient with the 1717SCC 140μm. In general, both the spatial and soft tissue contrast resolution are slightly superior using the 1717FCC. Specifically, the soft tissues on extremity films were seen with better clarity. There is little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.
The non-clinical test report contains the MTF, DQE and NPS performance test comparison between the subject device (1717FCC), and the predicate device (1717SCC), by using the identical test equipment and same analysis method described by IEC 62220-1.
The MTF and DQE testing represent the ability to visualize object details of a certain size and contrast. 1717FCC demonstrated equivalent or better performance in terms of MTF and DQE as well as NPS compared to 1717SCC, the predicate device, at all spatial frequencies.
The frame rate and image resolution for 1717 FCC, the subject device, perform better than the specification of the reference device, DRF 4343 (K080859) which are referenced in K131766.
Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivaleny between the subject device and the predicate device in terms of diagnostic image quality.
9
The manufacturing facility is in conformance with the design control procedure requirements specified in 21 CFR 820.30 and the relevant 21CFR820 standards as the records are available for review. Furthermore, the device conforms with all labeling requirements as per 21 CFR Subchapter J, specifically, 21 CFR 10120.30 and 1020.32.
7. Summary for any testing and reference guidance:
- A IEC 6220-1-1 Edition 1.0 2015-03 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
- A EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014
- A IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ♪ Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1: 2005, COR1:2006, COR2:2007, AMD1:2012 (Medical electrical equipment Part 1:General requirements for basic safety and essential performance) and IEC 60601-1-6:2010 (Third edition) +A1:2013
- A Non-clinical consideration according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices"
-
"Guidance for the Contents of Premarket Submission for Software Contained in Medical Device".
-
Pediatric Information for X-ray Imaging Device Premarket Notifications
-
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
8. Conclusions:
In accordance with the performance outcomes. 1717FCC demonstrated equivalent or better performance compared to 1717SCC(K171420) and SkyPlate (K171461). Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality about safety and effectiveness.