(23 days)
No
The document describes a standard digital X-ray detector and associated processing software. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The image processing mentioned is standard for converting raw data to DICOM files.
No.
The device is an X-ray detector intended for obtaining digital images for diagnostic purposes, not for therapeutic intervention.
No
This device is an X-ray detector that captures and digitalizes X-ray images. While these images are used for radiographic diagnosis, the device itself is an image acquisition component, not a device that directly performs diagnosis. The "radiographic diagnosis and analysis" occurs with separate console software that processes the RAW files generated by this device.
No
The device description clearly states it is a "digital solid state X-ray detector that is based on flat-panel technology" and consists of a "scintillator coupled to an a-Si TFT sensor." This indicates a physical hardware component for capturing X-ray images. While it uses software for processing, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "digital imaging solution designed for general radiographic system for human anatomy." This describes an imaging device used to visualize internal structures of the body, not to perform tests on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details an X-ray detector that captures and digitalizes X-ray images. This aligns with the function of a medical imaging device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in samples
- Providing information for diagnosis based on laboratory test results
The device is a component of a radiographic imaging system used for diagnostic procedures based on visual interpretation of X-ray images. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
1717SCV and 1717SGV X-ray detectors, 127um and 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
1717SCV / 1717SGV 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 an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis.
1717SCV and 1717SGV have the same Hardware, Software and components.
The type of scintillator layer are different: Cesium Iodide for 1717SCV and Gadolinium Oxsulfide for 1717SGV. Scintillator is a phosphor that produces scintillations.
The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection. Also, the subject detectors have an Automatic Exposure Control (AEC) feature.
The RAW files can be further processed as DICOM compatible image files by separate console SW (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview)/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The software used with the subject detectors is the same as the software XmaruView V1 used with the predicate K190866.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical test report for each subject device was prepared and submitted to FDA separately to demonstrate the substantial equivalency of the subject devices compared to each respective predicate device. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCV and 1717SGV by using the identical test equipment and same analysis method described by IEC 6220-1.
The MTF and DQE represent the ability to visualize object details of a certain size and contrast. 1717SCV and 1717SGV have similar MTF and DOE performance in comparison with 1717 SCC and 1717SGC, respectively, at all spatial frequencies.
The power adapter for 1717SCV and 1717SGV has been updated to RP005A from RS1717. The electrical safety test data demonstrates that the new power adapter is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF (3 lp/mm):
1717SCV: 127 type: 0.200, 140 type: 0.111
1717SGV: 127 type: 0.120, 140 type: 0.103
Predicate 1717SCC: 127 type: 0.176, 140 type: 0.106
Predicate 1717SGC: 127 type: 0.119, 140 type: 0.100
DQE (0.1 lp/mm):
1717SCV: 127 type: 0.675, 140 type: 0.682
1717SGV: 127 type: 0.405, 140 type: 0.414
Predicate 1717SCC: 127 type: 0.644, 140 type: 0.685
Predicate 1717SGC: 127 type: 0.401, 140 type: 0.383
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.
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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July 23, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.
Rayence Co., Ltd. % Mr. Dave Kim President Mtech Group 7707 Fannin St., Ste 200, V111 HOUSTON TX 77054
Re: K201796
Trade/Device Name: 1717SCV, 1717SGV Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: June 19, 2020 Received: June 30, 2020
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) K201796
Device Name 1717SCV / 1717SGV
Indications for Use (Describe)
1717SCV and 1717SGV X-ray detectors, 127um and 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.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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1. 510(k) Summary (K201796)
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: June 24, 2020
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: | 7707 Fannin St. Ste 200-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: | 1717SCV / 1717SGV |
|---|---|
| Model Name | : 1717SCV_127µm, 1717SCV_140µm |
| 1717SGV_127µm, 1717SGV_140µm | |
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Product Class | : Class 2 |
| Predicate Device #1: | |
| Trade/Device Name | : 1717scc_127um And 1717scc_140um |
| Common Name | : Digital Flat Panel X-ray Detector |
| Common Name | : Digital Flat Panel X-ray Detector |
|---|---|
| 510(k) Number | : K171420 |
| Regulation Number | : 21 CFR 892.1680 |
4
| Regulation Name | : Stationary X-ray System |
|---|---|
| Product Code | : MQB |
| Product Class | : Class 2 |
Predicate Device #2:
| Trade/Device Name | : 1717sgc_127um And 1717sgc_140um |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K171419 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Product Code | : MQB |
| Product Class | : Class 2 |
2. Device Description
1717SCV / 1717SGV 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 an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis.
1717SCV and 1717SGV have the same Hardware, Software and components.
The type of scintillator layer are different: Cesium Iodide for 1717SCV and Gadolinium Oxsulfide for 1717SGV. Scintillator is a phosphor that produces scintillations.
The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection. Also, the subject detectors have an Automatic Exposure Control (AEC) feature.
The RAW files can be further processed as DICOM compatible image files by separate console SW (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview)/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The software used with the subject detectors is the same as the software XmaruView V1 used with the predicate K190866.
3. Indication for use
1717SCV and 1717SGV X-ray detectors, 127um and 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.
5
4. Summary of Design Control Risk management
1717SCV / 1717SGV digital X-ray detector is a modification of 1717SCC (K171420) and 1717SGC (K171419). 1717SCV / 1717SGV 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.
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5. Summary of the technological characteristics of the device compared to the predicate device:
1717SCV / 1717SGV detector described in this 510(k) has the same indications for use and similar technical characteristics as its predicate device, 1717SCC (K171420) and 1717SGC (K171419).
| Characteristic | Proposed
Rayence Co.,Ltd.
1717SCV / 1717SGV | | Predicate
Rayence Co.,Ltd.
1717SCC and 1717SGC | | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------|
| Feature | Image: Proposed Rayence Co.,Ltd. 1717SCV / 1717SGV | | Image: Predicate Rayence Co.,Ltd. 1717SCC and 1717SGC | | |
| 510(k) number | | | K171420 | K171419 | Same |
| Intended Use | 1717SCC and 1717SGC X-ray detectors, 127um and 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. | | 1717SCC and 1717SGC X-ray detectors, 127um and 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, TFT | | Amorphous Silicon, TFT | | Same |
| Scintillator | 1717SCV
1717SGV | CsI:Tl
Gd2O2S:Tb | 1717SCC
1717SGC | CsI:Tl
Gd2O2S:Tb | Same |
| Imaging Area | 17 x 17 inches | | 17 x 17 inches | | Same |
| Pixel matrix | 127 : 3328 X 3328
140 : 3072 X 3072 | | 127 : 3328 X 3328
140 : 3072 X 3072 | | Same |
| Pixel pitch | 127 μm, 140 μm | | 127 μm, 140 μm | | Same |
| Resolution | 127 type: 3.93 lp/mm
140 type: 3.57 lp/mm | | 127 type: 3.93 lp/mm
140 type: 3.57 lp/mm | | Same |
| A/D conversion | 14 / 16 bit | | 14 bit for 127 μm / 16 bit for 140 μm | | Same |
| MTF (3 lp/mm) | 1717SCV
1717SGV | 127 type: 0.200
140 type: 0.111
127 type: 0.120
140 type: 0.103 | 1717SCC
1717SGC | 127 type: 0.176
140 type: 0.106
127 type: 0.119
140 type: 0.100 | Similar |
| DQE (0.1 lp/mm) | 1717SCV
1717SGV | 127 type: 0.675
140 type: 0.682
127 type: 0.405
140 type: 0.414 | 1717SCC
1717SGC | 127 type: 0.644
140 type: 0.685
127 type: 0.401
140 type: 0.383 | Similar |
Comparison table 5.1
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| RAW | RAW | Same | |
|---|---|---|---|
| Data output | *The RAW files are convertible into | ||
| DICOM 3.0 by console S/W | *The RAW files are convertible into | ||
| DICOM 3.0 by console S/W | |||
| Dimensions | 460 x 460 x 15.6 mm | 460 x 460 x 15.5 mm | Similar |
| Weight | 4.0 kg | 4.0 kg | Same |
| Application | General Radiology system or Portable system | ||
| Available with upright stand, table, universal stand. | General Radiology system or Portable system | ||
| Available with upright stand, table, universal stand. | Same | ||
| Power | |||
| Name | RP005A | RS1717 | Different |
| Feature | Image: RP005A | Image: RS1717 | |
| Type | POE | Power supply | |
| Rating | Input : 100-240 V a.c., 50/60 Hz, 1.2 A | ||
| Output : 54 V d.c., 0.75 A | Input: AC 100-240V, 50/60Hz 1.0 - 0.5A | ||
| Output : 24V, 1.60A | |||
| Connection with | |||
| detector | With LAN cable | With Link cable |
5.2 Scintillator layer
1717SCV and 1717SGV have the same Hardware, Software and components.
But *scintillator layer are different. ( * scintillator : a phosphor that produces scintillations)
| Proposed | Predicate | |
|---|---|---|
| CsI | ||
| (Cesium Iodide) | 1717SCV | 1717SCC |
| Gd2O2S:Tb | ||
| (Gadolinium Oxysulfide) | 1717SGV | 1717SGC |
5.3 Recommended Generator Specifications
| Model | Manufacture | Specification | |||
|---|---|---|---|---|---|
| CMP 200 | Communications & Power | ||||
| Industries | 32kW | 40kW | 50kW | ||
| kVp | 40-125 | 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 |
8
| mA | @100 kVp- 500 | ||
|---|---|---|---|
| mA | @80 kVp- 630 | ||
| PXR-321B | Poskom Co.,Ltd. | kVp | 125/150 |
| mA | 500 |
6. Summary of Performance Testing
1717SCV and 1717SGV digital flat panel X-ray detectors in comparison with 1717SCC and 1717SGC have the same indications for use, the same imaging area (17 x 17), based on the same scintillator material (CSI:TI for SCV and SCC, Gd202S:Tb for SGV and SGC ), same resolution performance. The pixel matrix for each pixel pitch size (127 um and 140 um) for both the subject devices and the predicate devices are identical. The recommended generator specifications for both the subject device and the predicate device remains the same.
The non-clinical test report for each subject device was prepared and submitted to FDA separately to demonstrate the substantial equivalency of the subject devices compared to each respective predicate device. The non-clinical test report contains the MTF, DQE and NPS test results of 1717SCV and 1717SGV by using the identical test equipment and same analysis method described by IEC 6220-1.
The MTF and DQE represent the ability to visualize object details of a certain size and contrast. 1717SCV and 1717SGV have similar MTF and DOE performance in comparison with 1717 SCC and 1717SGC, respectively, at all spatial frequencies.
The power adapter for 1717SCV and 1717SGV has been updated to RP005A from RS1717. The electrical safety test data demonstrates that the new power adapter is safe and effective.
7. Summary for any testing in the submission:
-
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)
- EMC testing were conducted in accordance with standard IEC 60601-1-2: 2014. A
-
IEC 62220-1 Ed 1.0 Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
-
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"
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8. Conclusions:
Based on the non-clinical consideration for both devices, Rayence, the sponsor, claims the substantial equivalency between the subject devices and their predicate devices in terms of diagnostic image quality without new concern for safety and effectiveness.