(48 days)
1212FCA, 1717FCC (K210985)
No
The document describes a digital X-ray detector and associated console software for image processing and analysis, but there is no mention of AI or ML technologies being used in the device or its software. The performance studies focus on traditional imaging metrics like MTF, DQE, and NPS.
No.
The device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is an X-Ray detector that creates images for "radiographic diagnosis and analysis" and is intended to "provide a case diagnosis and treatment planning for physicians and other health care professionals". This fits the definition of a diagnostic device.
No
The device description clearly details physical hardware components (flat panel detector, scintillator, CMOS active pixel detector, IGZO TFT sensor) that are integral to the device's function of capturing X-ray images. While software is mentioned for processing, it is not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a Digital Flat Panel X-Ray Detector. Its function is to capture and digitalize X-ray images of the human anatomy. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for human anatomy" and "to replace film based radiographic diagnostic systems." This aligns with in vivo diagnostic imaging.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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
MQB, JAA
Device Description
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Columnstructurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
The 1212FCA 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 IGZO 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.
The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
The subject detectors are connected to a viewing station by ethernet connection cable. There is no wireless option available.
The 0909 FCB and 1212FCA SSXI detectors should be tested and used with compatible X-ray generators which are not part of the imaging receptor device package.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
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)
0909FCB:
The non-clinical test report contains the MTF, DOE and NPS performance test comparison between the subject device (0909FCB), and the predicate device (1212FCA), 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. 0909FCB demonstrated equivalent or better performance in terms of MTF and DOE compared to 1212FCA, the predicate device, at all spatial frequencies.
1212FCA:
The non-clinical test report contains the MTF, DQE and NPS performance test comparison between 1212FCA, the subject device, and 1717FCC (K210985), the predicate device, 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. 1212FCA demonstrated equivalent performance in terms of MTF and better performance in terms of DQE compared to 1717FCC (K210985), the predicate device, at all spatial frequencies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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October 18, 2021
Image /page/0/Picture/1 description: The image shows 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 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., Ste 610 HOUSTON TX 77054
Re: K212753
Trade/Device Name: 0909FCB, 1212FCA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA Dated: October 12, 2021 Received: October 12, 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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
2
Indications for Use
510(k) Number (if known) K212753
Device Name 0909FCB, 1212FCA
Indications for Use (Describe)
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.
| 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 K212753
Date 510k summary prepared: October 6th,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 | : 0909FCB, 1212FCA |
|---|---|
| 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 | :1212FCA |
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K202722 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
| Product Code | : MQB |
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Image /page/4/Picture/1 description: The image shows the word "rayence" in red font. The font is sans-serif and appears to be slightly bolded. The word is presented on a white background, making the red color stand out. The image is a close-up of the word, with no other elements present.
Reference Device :
| Trade/Device Name | :1717FCC |
|---|---|
| Common Name | : Digital Flat Panel X-ray Detector |
| 510(k) Number | : K210985 |
| Regulation Number | : 21 CFR 892.1680 |
| Regulation Name | : Stationary X-ray System |
| Regulatory Class | : Class II |
| Product Code | : MQB, JAA |
2. Device Description
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Columnstructurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
The 1212FCA 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 IGZO 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.
The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
The subject detectors are connected to a viewing station by ethernet connection cable. There is no wireless option available.
The 0909 FCB and 1212FCA SSXI detectors should be tested and used with compatible X-ray generators which are not part of the imaging receptor device package.
3. Indication for use
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
5
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.
4. Summary of Design Control Risk management
0909FCB digital X-ray detector is a modification of 1212FCA (K202722). 1212FCA is identical to 1212FCA (K202722). 0909FCB and 1212FCA were developed for the purpose of retrofitting the stationary X-ray system with a film detector. 0909FCB is slightly smaller than 1212FCA (K202722). 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. Summary of the technological characteristics of the device compared to the predicate device:
0909FCB detector described in this 510(k) have the same indications for use and similar technical characteristics as its predicate devices, 1212FCA(K202722).
5.1 Scintillator laver
| * scintillator layer. ( * scintillator : a phosphor that produces scintillations) | ||||
|---|---|---|---|---|
| Proposed | Predicate | |
|---|---|---|
| CsI (Cesium Iodide) | 0909FCB, 1212FCA | 1212FCA |
5.2. Power source
| | | Proposed
0909FCB | Proposed
1212FCA | Predicate
1212FCA |
|-------|------------|-----------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------|
| Power | Type | Power adapter | Power adapter | Power adapter |
| | Model name | AHM85PS12 | AHM85PS24 | AHM85PS24 |
| | Dimension | 135 X 62 X 37
(cable length: 900 mm) | 150 X 64 X 37
(cable length: 900 mm) | 150 X 64 X 37
(cable length: 900 mm) |
| | Weight | 0.36kg | 0.5kg | 0.5kg |
| | Rating | Input: 100-240 Vac, 1.0 A,
50/60 Hz
Output: 12VDC (7.08A) | Input: 100-240 Vac, 1.0 A,
50/60 Hz
Output: 24VDC (Max
3.54A) | Input: 100-240 V, 1.0 A,
50/60 Hz
Output: 24VDC (3.54A) |
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Image /page/6/Picture/0 description: The image shows the word "rayence" in red font. The font is sans-serif and appears to be bolded. The word is written in all lowercase letters.
5.3 Generator specifications
(1) Generator specifications (0909FCB)
| Equipment | Model | Manufacture | Specification | |
|---|---|---|---|---|
| Large-focus | Small-focus | |||
| X-ray generator | HTC-35B | Poskom Co.,Ltd. | kVp | |
| 40-110 | ||||
| mA | ||||
| 25-40 | ||||
| KW (Power) | ||||
| 3.5 | kVp | |||
| 40-110 | ||||
| mA | ||||
| 0.2-10 | ||||
| KW (Power) | ||||
| 1.1 | ||||
| X-ray tube | DF-151SBR | Toshiba electron Co.,Ltd. | - |
(2) Generator specifications (1212FCA)
| Model | Manufacture | Specification | ||
|---|---|---|---|---|
| 32kW | 40kW | 50kW | ||
| CMP 200 | Communications & Power | |||
| Industries | kVp | |||
| 40-125 | 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 | ||||
| mA | ||||
| @100 kVp- 500(320) | ||||
| @80 kVp- 630(400) | ||||
| PXR-321B | Poskom Co.,Ltd. | kVp | ||
| 125/150 | ||||
| mA | ||||
| 500 |
7
| Characteristic | Proposed Device | Predicate Device | Similarity | |
|---|---|---|---|---|
| Manufacturer | Rayence Co.,Ltd. | Rayence Co.,Ltd. | ||
| Product Name | 0909FCB | 1212FCA | 1212FCA | |
| Feature | Image: 0909FCB | Image: 1212FCA | Image: 1212FCA | |
| 510(k) number | K212753 | K212753 | K202722 | |
| Intended Use | 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. | 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. | 1212FCA 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. | Same | |||
| Detector Type | CMOS Photodiode | |||
| Array | IGZO TFT + PIN type | |||
| photodiode | IGZO TFT + PIN type | |||
| photodiode | 0909FCB and | |||
| 1212FCA has | ||||
| different detector | ||||
| type but it is | ||||
| same indirect | ||||
| conversion | ||||
| method of | ||||
| Radiation image | ||||
| detection | ||||
| Scintillator | CsI:Tl | CsI:Tl | CsI:Tl | Same |
| Imaging Area | 9 x 9 inches | 12 x 12 inches | 12 x 12 inches | - |
| Total Pixel | ||||
| matrix | 2304×2256 (1x1) | |||
| 1152×1128 (2×2) | 1536 X 1536 (1x1) | |||
| 768 X 768 (2x2) | 1536 X 1536 (1x1) | |||
| 768 X 768 (2x2) | Similar |
5.4 Comparison with Predicate Device
rayence
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Image /page/8/Picture/1 description: The image contains the word "rayence" in red font. The font is sans-serif and appears to be bolded. The word is written in all lowercase letters.
| Pixel pitch | 90 μm (1x1)
180 μm (2x2) | 194 μm (1x1)
388 μm (2x2) | 194 μm (1x1)
388 μm (2x2) | Similar | | |
|----------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------|----------------------|----------------------------------------------------------------------|
| A/D conversion | 16 bits | 14 / 16 bit | 14 / 16 bit | Similar | | |
| Frame rate | Camera link (Base)
15 fps (1x1)
30 fps (2x2) | GigE | 18 (1x1)
36 (2x2) | GigE | 18 (1x1)
36 (2x2) | GigE cable type is same.
0909FCB has additional camera link type. |
| | Camera link (Medium)
30 fps (1x1)
30 fps (2x2) | | | | | |
| | GigE
10 fps (1x1)
30 fps (2x2) | | | | | |
| MTF | 1.0 lp/mm, 0.689
1.5 lp/mm, 0.512
2.0 lp/mm, 0.394
2.5 lp/mm, 0.274 | 0.1 lp/mm, 0.527
1 lp/mm, 0.327
2 lp/mm, 0.210
2.5 lp/mm, 0.136 | 0.1 lp/mm, 0.527
1 lp/mm, 0.327
2 lp/mm, 0.210
2.5 lp/mm, 0.136 | Similar | | |
| | DQE (0) | 0.581 | 0.778 | 0.778 | Similar | |
| | Preview time | ≤2 seconds | ≤2 seconds | ≤2 seconds | Same | |
| | 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 | RAW
*The RAW files are convertible into DICOM 3.0 by console S/W | Same | |
| Dimensions | 245.0 x 245.0 x 55.0mm | 334.0 x 326.0 x 49.9 mm | 334.0 x 326.0 x 49.9 mm | Similar | | |
| Weight | 3.2 kg | 3.4 kg | 3.4 kg | Similar | | |
9
| Characteristic | Proposed Device | Reference | ||
|---|---|---|---|---|
| Manufacturer | Rayence Co.,Ltd. | Rayence Co.,Ltd. | Similarity | |
| Product Name | 0909FCB | 1212FCA | 1717FCC | |
| Feature | Image: 0909FCB | Image: 1212FCA | Image: 1717FCC | |
| 510(k) number | K212753 | K212753 | K210985 | |
| Intended Use | 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. | 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. | 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. | Similar | |||
| 1717FCC is | ||||
| large size of | ||||
| detector | ||||
| therefore it can | ||||
| use whole human | ||||
| anatomy for | ||||
| digital imaging | ||||
| solution. In case | ||||
| of 0909FCB and | ||||
| 1212FCA are | ||||
| small size of | ||||
| detector | ||||
| therefore it can | ||||
| use for human | ||||
| anatomy | ||||
| including head, | ||||
| neck, cervical | ||||
| spine, arm, leg | ||||
| and peripheral | ||||
| (foot, hand, | ||||
| wrist, fingers, | ||||
| etc.). | ||||
| Detector Type | CMOS | |||
| Array | Photodiode | |||
| IGZO TFT + PIN type | ||||
| photodiode | a-Si TFT + PIN type | |||
| photodiode | ||||
| IGZO TFT + PIN type | ||||
| photodiode (option) | 0909FCB and | |||
| 1717FCC has | ||||
| different detector | ||||
| type but it is | ||||
| same indirect | ||||
| conversion method of | ||||
| Radiation image | ||||
| detection | ||||
| Scintillator | CsI:Tl | CsI:Tl | CsI:Tl | Same |
| Imaging Area | 9 x 9 inches | 12 x 12 inches | 17 x 17 inches | |
| Total Pixel | ||||
| matrix | $2304\times2256$ (1x1) | |||
| $1152\times1128$ (2x2) | $1536 X 1536$ (1x1) | |||
| $768 X 768$ (2x2) | $3072 X 3072$ (1x1) | |||
| $1536 X 1536$ (2x2) | Similar |
rayence
5.5 Comparison with Reference Device
10
| 768 X 768 (4x4) | Similar | ||||||
|---|---|---|---|---|---|---|---|
| Pixel pitch | 90 (1x1) | ||||||
| 180 (2×2) | 194 µm (1x1) | ||||||
| 388 µm (2x2) | 140 (1x1) | ||||||
| 280 (2x2) | |||||||
| 420 (3x3) | |||||||
| 560 (4x4) | |||||||
| A/D | |||||||
| conversion | 16 bits | 14 / 16 bit | 14 / 16 bits | Similar | |||
| Frame rate | Camera | ||||||
| link | |||||||
| (Base) | 15 fps | ||||||
| (1x1) | |||||||
| 30 fps | |||||||
| (2x2) | Camera link | 9 fps (1x1) | |||||
| 30 fps (2x2) | |||||||
| 45 fps (3x3) | |||||||
| 60 fps (4x4) | -GigE cable | ||||||
| type is same. | |||||||
| -0909FCB and | |||||||
| Camera | |||||||
| link | |||||||
| (Medium) | 30 fps | ||||||
| (1x1) | |||||||
| 30 fps | |||||||
| (2x2) | GigE | 18 (1x1) | |||||
| 36 (2x2) | GigE | 6 fps (1x1) | |||||
| 25 fps (2x2) | |||||||
| 45 fps (3x3) | |||||||
| 60 fps (4x4) | 1717FCC have | ||||||
| additional | |||||||
| camera link | |||||||
| type and 5GigE | |||||||
| type. | |||||||
| GigE | 10 fps | ||||||
| (1x1) | |||||||
| 30 fps | |||||||
| (2x2) | 5GigE | 15 fps (1x1) | |||||
| 30 fps (2x2) | |||||||
| 45 fps (3x3) | |||||||
| 60 fps (4x4) | |||||||
| MTF | 1.0 lp/mm, 0.689 | 0.1 lp/mm, 0.527 | 1.0 lp/mm, 0.535 | Similar | |||
| 1.5 lp/mm, 0.512 | 1 lp/mm, 0.327 | 2.0 lp/mm, 0.220 | |||||
| 2.0 lp/mm, 0.394 | 2 lp/mm , 0.210 | 3.0 lp/mm, 0.099 | |||||
| 2.5 lp/mm, 0.274 | 2.5 lp/mm , 0.136 | 3.5 lp/mm, 0.073 | |||||
| DQE (0) | 0.581 | 0.778 | Typ. 0.751 | Similar | |||
| Preview time |
0909FCB Digital Flat Panel X-Ray Detector has the same indications for use, the same scintillator material (CsI:TI ) and the same risk analysis characteristics compared to 1212FCA, the predicate devices (K202722). 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 0909FCB and 1212FCA, the images obtained with 0909FCB and 1212FCA were equivalent quality for the same view obtained from a similar patient with the 1212FCA.
The soft tissues on extremity films were seen with similar clarity for 0909FCB and 1212FCA. There was little difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion.
The non-clinical test report contains the MTF, DOE and NPS performance test comparison between the subject device (0909FCB), and the predicate device (1212FCA), 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. 0909FCB demonstrated equivalent or better performance in terms of MTF and DOE compared to 1212FCA, the predicate device, at all spatial frequencies.
Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality.
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 will conform with all labeling requirements as per 21 CFR Subchapter J.
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1212FCA Digital Flat Panel X-Ray Detector, the subject device, is identical to 1212FCA (K202722). 1212FCA has similar indications for use, the same scintillator material (CsI:Tl ), the same generator specifications and the same risk analysis characteristics compared to 1717FCC (K210985), the reference devices. The pixel matrix and pixel pitch sizes are different due to different imaging areas but the differences do not raise new concerns for the safety and effectiveness of the subject device.
The non-clinical test report contains the MTF, DQE and NPS performance test comparison between 1212FCA, the subject device, and 1717FCC (K210985), the predicate device, 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. 1212FCA demonstrated equivalent performance in terms of MTF and better performance in terms of DQE compared to 1717FCC (K210985), the predicate device, at all spatial frequencies.
Based on the non-clinical consideration evaluation, the sponsor can claim the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality.
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.
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7. Summary for any testing and reference guidance:
- ♪ 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 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 efficiency Detectors 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"
- A "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 A
8. Conclusions:
In accordance with the performance outcomes, 0909FCB, 1212FCA demonstrated equivalent or better performance compared to the predicate and reference devices. Therefore, Rayence claims the substantial equivalency between the subject device and the predicate device in terms of diagnostic image quality about safety and effectiveness.