(16 days)
No
The summary describes a standard digital X-ray detector and its associated SDK, with no mention of AI or ML capabilities for image processing, analysis, or any other function. The performance study focuses on image quality comparison to a predicate device, not on the performance of any AI/ML algorithm.
No.
The device is used for diagnostic imaging (digital X-ray) to replace film/screen systems, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy." This directly indicates its role in diagnostic procedures.
No
The device description clearly states that Venul 717X is a "cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology," which is a hardware component. While it includes software (iRay SDK), the core device is a physical detector.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Venul 717X is an X-ray flat panel detector. Its function is to capture digital radiographic images of the human body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This involves imaging the internal structures of the body, not analyzing samples taken from the body.
Therefore, based on the provided information, the Venul 717X is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Venul 717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in general-purpose diagnostic procedures.
Product codes
MQB
Device Description
Venu1717X is a cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiographic image which contains an active matrix of 3070×3070 with 139um pixel pitch. The scintillator of Venu1717X is CsI(Caesium Iodide). The technology of CsI direct growth reduces the exposure dose and improves the image quality. Since Venu1717X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system.
iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adult and pediatric patients.
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)
Clinical Consideration: A concurrence study of 30 clinical images was conducted to compare the performance of the Venul 717X to that of the predicate device (Mars 1717V-VSI, K201043).
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
There was no significant difference between the images of the Venu1717X and those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 29, 2022
iRay Technology Taicang Ltd. % Guo Wu Registration & Regulation Affairs Engineer No. 33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K221714
Trade/Device Name: Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: May 10, 2022 Received: June 13, 2022
Dear Guo Wu:
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
1
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 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 (OS) 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221714
Device Name Flat Panel Detector
Indications for Use (Describe)
Venul 717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in general-purpose diagnostic procedures.
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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K221714 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
April 15, 2022
2. Submitter;s Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic and |
| Technological Development Zone, Jiangsu, China 215434 | |
| Contact Person: | Guo Wu |
| Phone: | 0512- 50720539 |
| Fax: | 0512- 50720539 |
| Email: | guo.wu@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Venu1717X |
| Classification Name: | Stationary x-ray system |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4. Identification of Predicate Devices(s)[21 CFR 807.92(a)(3)]
The identification predicates within this submission are as follows:
| Manufacturer: | iRay Technology Taicang Ltd. |
|---|---|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1717V-VSI |
| Product Code: | MQB |
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Classification Name: Stationary x-ray system FDA 510 (k) #: K201043
5. Description of the Device [21 CFR 807.92(a)(4)]
Venu1717X is a cassette-size tethered X-ray flat panel detector based on amorphous silicon thin-film transistor technology. It is designed to provide the high quality radiographic image which contains an active matrix of 3070×3070 with 139um pixel pitch. The scintillator of Venu1717X is CsI(Caesium Iodide). The technology of CsI direct growth reduces the exposure dose and improves the image quality. Since Venu1717X supports multiple trigger modes, it can satisfy both of the general DR system and retrofit DR system.
iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Intended Use
Venu1717X is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including adults only. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable health problem. The image is obtained as the result of X-ray passing through the human body and detected by the equipment.
iRay will provide equipment and software support for integration of system.
6.2. Suitable patient
This panel is not intended for mammography or dental applications, and not recommend for pregnant women and new born.
6.3. Processing of input and output
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable
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5
health problem.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Flat Panel Detector |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K201043 | K221714 |
| Intended Use | The Mars1717V-VSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging
solution designed for providing
general radiographic system in
allgeneral-purpose diagnostic
procedures. | This equipment provides digital X-
ray imaging for diagnosis of
disease, injury, or any applicable
health problem. The image is
obtained as the result of X-ray
passing through the human body
and detected by the equipment.
iRay will provide equipment and
software support for integration of
system. |
| Indications for
Use | Mars1717V-VSI is indicated for
digital imaging solutions
designed to provide general
radiographic diagnosis for human
anatomy including both adult and
pediatric patients. It is intended to
replace film/screen systems in all
general-purpose diagnostic
procedures. | Venu1717X is indicated for digital
imaging solutions
designed to provide general
radiographic diagnosis for human
anatomy including adults only. It is
intended to replace film/screen
systems in all general-purpose
diagnostic procedures. |
| Classification
Name | Stationary x-ray system | Same |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber
(Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Wired, Portable |
| Detector structure: | Amorphous silicon TFT | Same |
| | Predicate Device: | |
| Item | Wireless Digital Flat Panel | Proposed Device: |
| | Detector | Flat Panel Detector |
| Dimensions: | 460 mm× 460 mm × 15 mm | Same |
| Image Matrix Size: | 3072 × 3072 pixels | Same |
| Pixel Pitch: | 139μm | Same |
| Effective
Imaging
Area: | 427mm×427mm | Same |
| ADC
Digitization | 16 bit | Same |
| Spatial Resolution | Min. 3.6lp/mm | Min. 3.4 lp/mm |
| Modulation
Transfer
Function (MTF) | 0.65 at 1 lp/mm | 0.66 at 1 lp/mm |
| Detective
Quantum
Efficiency
(DQE) | 0.40 at 1 lp/mm (RQA5, 2.5µGy) | 0.28 at 1 lp/mm (RQA5, 2.5µGy) |
| Imaging protect
Plate: | Carbon Fiber Plate | Same |
| Power Consumption: | Max. 30W | Max. 20W |
| Communications: | a) Wired (only for
service): Gigabit
Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz
/ 5 GHz) | Wired: Gigabit
Ethernet (1000BASE-T) |
| Cooling: | Air cooling | Same |
| Protection against
matter/Water | IPX1 | IPX1 |
| Protection against
shock | Type B applied part | Same |
| Operation: | Temperature: +5 ~ +35°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 55 ~
106 kPa
Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C
Humidity: 30 ~ 80%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters |
| Storage and
Transportation:
( detector ) | Temperature: -10 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing) | Temperature: 10 to 55°C
Humidity: 10 ~ 90%
(Non-Condensing) |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Flat Panel Detector |
| | Atmospheric pressure: 55 ~
106 kPa
Altitude: Max. 3000 meters | Atmospheric pressure: 70 ~ 106
kPa
Altitude: Max. 3000 meters |
| Software | iDetector | iDetector |
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iRay Technology Taicang Ltd.
[510(k)] Application
8. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification:
Energy range: 40~150kV
- Recommended Generator Specification:
mA range: 10~1000mA (depending on the generator power)
ms range: 106300ms to produce 0.11000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer
Peripheral hardware: Venu1717X connected via wired communication.
- Application Program Interface (API) for system integration manufacturer
| Operating System: | Windows 10 or above 32/64bit |
|---|---|
| CPU: | Intel Core i7 dual core, or even higher |
| Memory: | 4G or higher |
| Hard Disk: | 160 G or higher |
| LAN Card: | Intel Gigabit CT adapter Network Interface Card |
| or equivalent |
-
- X-ray exposure mode
The inner trigger module is a unit can connect X-ray signal in the Venu1717X. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.
- X-ray exposure mode
8
9. Nonclinical study
-
- Electrical Safety and EMC testing:
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-54 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
- Electrical Safety and EMC testing:
-
- Biological Evaluation:
The top cover surface film and painting materials of the detector may contact patients'skin, this has been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
- Biological Evaluation:
-
- Nonclinical Considerations:
According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the Venu1717X is substantially equivalent to the predicate devices on the Market (K201043):
- Nonclinical Considerations:
Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time. According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software SDK(contains iDetector) classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification.
-
- Clinical Consideration:
A concurrence study of 30 clinical images was conducted to compare the performance of the Venul 717X to that of the predicate device (Mars 1717V-VSI, K201043).
- Clinical Consideration:
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
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There was no significant difference between the images of the Venu1717X and those of the predicate device.
-
- Cybersecurity:
According to the Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the Venu1717X had passed the assessment related to Cybersecurity.
- Cybersecurity:
10. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. Concludes that iRay Venu1717X is substantially equivalent to predicate device with regards to safety and effectiveness.