(20 days)
Not Found
No
The document describes standard digital radiography technology and image processing, but there is no mention of AI or ML.
No
The device is an X-ray flat panel detector intended to capture and display radiographic images for diagnostic purposes, not for treating diseases or conditions.
Yes
The device captures radiographic images of human anatomy and processes them for display to a computer, which is a key function in diagnosing medical conditions by providing visual information about internal structures.
No
The device description explicitly states it is a "portable digital detector system" and includes hardware components like a "flat panel for x-ray acquisition and digitization" and a "computer". While it includes software (DROC), 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 that the device is for capturing and displaying radiographic images of human anatomy for general projection radiographic applications. This involves imaging the internal structure of the body using X-rays.
- Device Description: The description details a flat panel detector that collects and digitizes X-ray images. It works with an external X-ray source and a computer for processing and display.
- Nature of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
The device described is a medical imaging device used for diagnostic purposes, but it operates by capturing images of the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Wireless/Wired Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Product codes
MQB
Device Description
InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model F14C, F14G are portable digital detector system. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model F14C, F14G support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Every model have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (CsI)).
The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
Yushan series is working by using DROC(Digital Radiography Operating Console). The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:
-
- Detector status update
-
- Xray exposure workflow
-
- Image viewer and measurement.
-
- Post image process and DICOM file I/O
-
- Image database: DROC support the necessary DICOM Services to allow a smooth integration into the clinical network
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
Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (F14C, F14G) confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Radio Frequency Wireless Technology in Medical Devices (issued on August 14, 2013), FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E and FCC SAR were followed to test the wireless features; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 2, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionally, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489-17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017, and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
InnoCare Optoelectronics Corp. % Yumei Cheng Principal Engineer Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744 Taiwan (R.O.C.) Tainan City, Taiwan (R.O.C.) 744 TAIWAN
Re: K210988
Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: March 15, 2021 Received: April 8, 2021
Dear Yumei Cheng:
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
April 21, 2021
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K210988
Device Name
Yushan X-Ray Flat Panel Detector with DROC
Indications for Use (Describe)
The Wireless/Wired Yushan X-Ray Flat Panel Detector with DROC is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector with DROC is not intended for mammography, fluoroscopy, tomography, and angiography applications.
| 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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3
Section 5 510(k) Summary
I. SUBMITTER
InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Xinshi Dist., Tainan City 744, Taiwan (R.O.C.) TEL: +886-6-700-7238 # 22598 Email: yumei.cheng@innocare-x.com Contact Person: Yumei Cheng / Senior Engineer Date Prepared: Mar 15, 2020
II. DEVICE
Trade name: Yushan X-Ray Flat Panel Detector with DROC Model name: F14C, F14G Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II
III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows: Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Decision Date: 10/11/2020 Regulation description: Stationary x-ray system. Review panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 Device class: Class II
4
IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFI-CATION
InnoCare's Yushan X-Ray Flat Panel Detector with DROC, model F14C, F14G are portable digital detector system. The Yushan X-Ray Flat Panel Detector with DROC is designed to be used in any environment that would typically use a radiographic cassette for examinations. Model F14C, F14G support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. Every model have memory exposure mode, and extended image readout feature. Additionally, roundededge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
The Yushan X-Ray Flat Panel Detector with DROC is currently indicated for general projection radiographic applications and offers two different detector types in terms of scintillator materials (gadolinium oxysulfide (GOS) and cesium iodide (Csl)).
The Yushan X-Ray Flat Panel Detector with DROC sensor can automatically collects x-ray images from an x-ray source. It collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided and controlled by independent system manufacturers. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
Yushan series is working by using DROC(Digital Radiography Operating Console). The DROC is a software running on a Windows PC as an user interface for radiologist to perform a general radiography exam. The function include:
-
- Detector status update
-
- Xray exposure workflow
-
- Image viewer and measurement.
-
- Post image process and DICOM file I/O
-
- Image database: DROC support the necessary DICOM Services to allow a smooth
FDA-Summary-A1 2of8
5
integration into the clinical network
The software level of concern for the Yushan X-Ray Flat Panel Detector with DROC has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The cybersecurity risks of the Yushan X-Ray Flat Panel Detector with DROC have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Yushan X-Ray Flat Panel Detector with DROC (F14C, F14G) and its predicate device, K201528, Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) are portable digital detector systems. Yushan X-Ray Flat Panel Detector with DROC has the same Indications for Use, and very similar functional and technical requirements as the predicate device, K201528. The comparison of technological characteristics are listed in the following table. Yushan X-Ray Flat Panel Detector with DROC has been successfully tested and validated, there are 2 models in this submission, F14C, F14G, which are the serial models using the same user interface, DROC. The only difference is F14C, F14G is using a non-glass substrate, while the models in K201528 are using glass substrate, no further change to device functionality, operation and mechnism.
| Product name | Yushan X-Ray Flat Panel Detector
with DROC | Yushan X-Ray Flat Panel Detector
with DROC |
|--------------|-----------------------------------------------|-----------------------------------------------|
| Model name | F14G | V14G |
| | F14C | V14C |
| | | V17G |
| | | V17C |
Please refer to the following table for more detailed information.
FDA-Summary-A1 3of8
6
| V17Ge | |||
|---|---|---|---|
| Manufacturer | InnoCare Optoelectronics Corp. | InnoCare Optoelectronics Corp. | InnoCare Optoelectronics Corp. |
| Qualified | |||
| number | - | - | CE2460/K201528 |
| Clinical | |||
| Intended use | The Wireless/Wired Yushan X-Ray | ||
| Flat Panel Detector with DROC is | |||
| intended to capture for display ra- | |||
| diographic images of human anat- | |||
| omy. It is intended for use in gen- | |||
| eral projection radiographic appli- | |||
| cations wherever conventional | |||
| film/screen or CR systems may be | |||
| used. The Yushan X-Ray Flat | |||
| Panel Detector with DROC is not | |||
| intended for mammography, fluo- | |||
| roscopy, tomography, and an- | |||
| giography applications. | The Wireless(V14C, V14G, V17C, | ||
| V17G)/Wired(V14C, V14G, | |||
| V17C, V17G, V17Ge) Yushan X- | |||
| Ray Flat Panel Detector with | |||
| DROC is intended to capture for | |||
| display radiographic images of | |||
| human anatomy. | |||
| It is intended for use in general | |||
| projection radiographic applica- | |||
| tions wherever conventional | |||
| film/screen or CR systems may be | |||
| used. The Yushan X-Ray Flat | |||
| Panel Detector with DROC is not | |||
| intended for mammography, fluo- | |||
| roscopy, tomography, and an- | |||
| giography applications. | |||
| Compliance | |||
| standard | - FDA Standards 21 CFR | ||
| 892.1680 for stationary x-ray | |||
| system | |||
| European Medical Devices | |||
| Directive (93/42/EEC) | |||
| EN ISO 13485 | |||
| ISO 14971 | - FDA Standards 21 CFR | ||
| 892.1680 for stationary x-ray | |||
| system | |||
| European Medical Devices | |||
| Directive (93/42/EEC) | |||
| EN ISO 13485 | |||
| ISO 14971 | |||
| - ANSI/AAMI ES60601-1 |
-
CAN/CSA C22.2 No. 60601-1:14 -
IEC 60601-1-2 -
IEC 62304 -
IEC 60601-1-6 -
IEC 62366-1 -
ISO 10993-1 -
ISO 10993-5 -
ISO 10993-10 -
ISO 15223-1 | - ANSI/AAMI ES60601-1 -
CAN/CSA C22.2 No. 60601-1:14 -
IEC 60601-1-2 -
IEC 62304 -
IEC 60601-1-6 -
IEC 62366-1 -
ISO 10993-1 -
ISO 10993-5 -
ISO 10993-10 -
ISO 15223-1 | |
| | Technical | | |
| Dimensions
(mm) | F14G:
460(W)×383(L)×15(H)
F14C:
460(W)×383(L)×15(H) | V14G:
460(W)×383(L)×15(H)
V14C:
460(W)×383(L)×15(H)
V17G:
460(W)×460(L)×15(H)
V17C:
460(W)×460(L)×15(H)
V17Ge:
460(W)×460(L)×15(H) | |
| | | | |
| Weight (Kg) | F14G: 2.3
F14C: 2.5 | V14G: 2.7
V14C: 2.7
V17G: 3.2
V17C: 3.2
V17Ge: 3.5 | |
| Substrate | Non-Glass
(polyethylene terephthalate laminate) | Glass | |
| | | | |
| Scintillator | F14G: GOS
F14C: CsI | V14G: GOS
V14C: CsI
V17G: GOS
V17C: CsI
V17Ge: GOS | |
| Pixel Pitch | 140 µm | 140 µm | |
| DQE | GOS: at 1 lp/mm, RQA5 is 0.27
CsI: at 1 lp/mm, RQA5 is 0.50 | GOS: at 1 lp/mm, RQA5 is 0.27
CsI: at 1 lp/mm, RQA5 is 0.48 | |
| MTF | GOS: at 1 lp/mm, RQA5 is 0.52
CsI: at 1 lp/mm, RQA5 is 0.63 | GOS: at 1 lp/mm, RQA5 is 0.52
CsI: at 1 lp/mm, RQA5 is 0.69 | |
| Max.
resolution | GOS: 3.57 lp/mm
CsI: 3.57 lp/mm | GOS: 3.57 lp/mm
CsI: 3.57 lp/mm | |
| A/D Conver-
sion | 16 bit | 16 bit | |
| Pixels | F14G: 2500 x 3052
F14C: 2500 x 3052 | V14G: 2500 x 3052
V14C: 2500 x 3052
V17G: 3072 x 3072
V17C: 3072 x 3072
V17Ge: 3072 x 3072 | |
| Interface | Wired: Gigabit Ethernet
(100BASE-TX or 10BASE-T)
Wireless: IEEE802.11 ac /a/g/n | Wired: Gigabit Ethernet
(100BASE-TX or 10BASE-T)
Wireless: IEEE802.11 ac /a/g/n
- V17Ge is not applicable for
wireless function. | |
| Power Source | Rechargeable Lithium Battery | Rechargeable Lithium Battery - V17Ge is not applicable | |
| Biological
safety | All material contact with patients
are in accordance with ISO 10993. | All material contact with patients
are in accordance with ISO 10993. | |
| | Others | | |
| Accessories | - Battery (Optional)
- Power supply (Adapter)
- SE cable (Back-up cable)
- Power Cord (Optional)
- Charger (Optional)
- Charger Adapter (Optional)
- DROC Dongle (Optional) | - Battery (Optional)* V17Ge is
not applicable - Power supply (Adapter)
- SE cable (Back-up cable)
- Power Cord | |
7
8
9
VI. PERFORMANCE DATA
Non-clinical Performance Data: Yushan X-Ray Flat Panel Detector with DROC (F14C, F14G) confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Radio Frequency Wireless Technology in Medical Devices (issued on August 14, 2013), FCC 47 CFR PART 15 SUBPART C, FCC 47 CFR PART 15 SUBPART E and FCC SAR were followed to test the wireless features; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 2, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionaly, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC60601-1-2, FCC 47 CFR PART 15 SUBPART B, ETSI EN 301 489-17 V3.1.1:2017 and ETSI EN 301 489-1 V2.1.1:2017, and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation con-
10
firmed that the image quality of the Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
VII. CONCLUSIONS
Yushan X-Ray Flat Panel Detector with DROC is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties.
Yushan X-Ray Flat Panel Detector with DROC is designed to comply with applicable federal and international safety and performance standards.
Based upon the supporting data summarized above, we concluded the Yushan X-Ray Flat Panel Detector with DROC (F14C, F14G) is as safe and effective as the legally marketed device Yushan X-Ray Flat Panel Detector with DROC (V14C, V14G, V17C, V17G, V17Ge) (K201528), and do not raise different questions of safety and effectiveness than K201528.