(27 days)
No
The description focuses on the hardware and basic image processing functions of a digital flat panel detector, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No.
The device is a digital flat panel detector used for obtaining radiographic images for diagnosis, not for providing therapy.
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."
No
The device description explicitly details hardware components like a sensor plate, CsI scintillator, TFT panel, scanning and readout electronics, and cables, indicating it is a hardware device that converts X-rays to digital images. While it mentions accompanying software (iRay DR), the core device is hardware.
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 solutions designed to provide general radiographic diagnosis for human anatomy". This describes a device used to capture images of the body, not to perform tests on biological samples in vitro (outside the body).
- Device Description: The description details how the device converts X-rays into digital images. This process is entirely focused on capturing and processing images of the patient's internal structures, not on analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is solely related to capturing and processing X-ray images.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or treatment. This device's function falls under the category of medical imaging equipment.
N/A
Intended Use / Indications for Use
Mercul 717V Digital Flat Panel Detector 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. The device is not intended for mammography or dental applications.
Product codes
MQB
Device Description
Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging.
The sensor plate of Mercu1717V is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the cable.
The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
Mentions image processing
Yes
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)
The non-clinical studies have been performed and the results have shown that the Mercu1717V digital flat panel detector is substantially equivalent to the predicate devices on the Market (K221714)
Parameter about image quality is equal to or better than predicate device parameter According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iRayDR classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
October 20, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iRay Technology Taicang Ltd. % Junjie Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K222886
Trade/Device Name: Mercu1717V Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 13, 2022 Received: September 23, 2022
Dear Junjie Qian:
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
2
Indications for Use
510(k) Number (if known) K222886
Device Name Mercu1717V
Indications for Use (Describe)
Mercul 717V Digital Flat Panel Detector 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. The device is not intended for mammography or dental 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
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92) K222886
1. Date Prepared [21 CFR 807.92(a)(1)]
July 13, 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: | Junjie. Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | junjie.qian@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mercu1717V |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
4
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
| Manufacturer: | iRay Technology Co., Ltd. |
|---|---|
| Trade Name: | Flat Panel Detectors |
| Model Name: | Venu1717X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K221714 |
5. Identification of Reference Devices(s) [21 CFR 807.92(a)(3)[
| Manufacturer: | CareRay Digital Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | X-ray Flat Panel Detectors |
| Model Name: | CareView 3600RF |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K202995 |
6. Description of the Device [21 CFR 807.92(a)(4)]
Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging.
The sensor plate of Mercu1717V is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the cable.
5
The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
7. Intended Use [21 CFR 807.92(a)(5)]
7.1. Indications for use
Mercu1717V digital flat panel detector 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. The device is not intended for mammography or dental applications.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
Mercu1717V Digital flat panel detector get signal from high-voltage generator, and then it gets ready to output radiographic imaging for diagnosis of disease, injury, or of any applicable health problem to iRayDR installed in PC. iRayDR get raw image and output clinical image after enhancement processing for raw image is finished.
6
| Item | Predicate Device:
Venu1717X Digital
Flat Panel Detector | Reference Device:
CareView 3600RF X-ray
Flat Panel Detector | Proposed Device:
Mercu1717V Digital Flat Panel
Detector |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K221714 | K202995 | K222886 |
| Intended Use | 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. | The CareView 3600RF
detector is indicated for
digital imaging solution
designed for providing
general radiographic
diagnosis of human
anatomy. It is intended to
replace radiographic
film/screen systems in all
general-purpose
diagnostic procedures.
This product is not
intended for
mammography
applications. | Mercu1717V Digital Flat Panel
Detector is indicated for digital
imaging solution designed for
providing general radiographic
system in all general-purpose
diagnostic procedures. |
| Indications for
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 | / | Mercu1717V 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. The
device is not intended for |
| | Predicate Device: | Reference Device: | Proposed Device: |
| Item | Venu1717X Digital
Flat Panel Detector
all general-purpose
diagnostic procedures. | CareView 3600RF X-ray
Flat Panel Detector | Mercu1717V Digital Flat Panel
Detector
mammography or dental
applications. |
| Classification
Name | Stationary X-ray system | Stationary X-ray system | Same |
| Product Code | MQB | MQB | Same |
| Regulation
Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Radiology | Same |
| Classification: | II | II | Same |
| X-Ray Absorber
(Scintillator): | CSI | GOS | CSI |
| Installation Type: | Wired | Same | Same |
| Readout
Mechanism: | Thin Film Transistor | Same | Same |
| Image Matrix
Size: | 3072 × 3072 pixels | 5632 × 2816 pixels | Min. 1024 × 1024 pixels
(@binning 3×3)
Max.3072 ×3072 pixels
(@binning 1×1) |
| Pixel Size: | 139μm | 154 μm | 139μm |
| ADC Digitization | 16 bit | Same | Same |
| Effective Imaging
Area: | 427mm×427mm | 867.5mm × 433.1 mm | Min.285mm×285mm
(@zoom on)
Max.427mm × 427mm
(@zoom off) |
| Spatial
Resolution: | Min. 3.4 lp/mm | Same | Same |
| | Predicate Device:
Venu1717X Digital
Flat Panel Detector | Reference Device:
CareView 3600RF X-ray
Flat Panel Detector | Proposed Device:
Mercu1717V Digital Flat Panel
Detector |
| Item | | | |
| MTF | 0.66 at 1 lp/mm | 0.75 at 0.5lp/mm
0.5 at 1lp/mm | 0.78 at 0.5lp/mm
0.55 at 1lp/mm |
| Detective
Quantum
Efficiency
(DQE) | 0.28 at 1 lp/mm
(RQA5, 2.5µGy) | 0.28 at 0.5 lp/mm
0.20 at 1 lp/mm
(RQA5, 3.2µGy) | 0.4 at 0.5 lp/mm
0.35 at 1 lp/mm
(RQA5, 2.5µGy) |
| Power
Consumption: | Max. 20W | ~50W | 18 W |
| Communications: | Gigabit
Ethernet | Same | Same |
| Imaging protect
Plate: | Carbon Fiber Plate | Same | Same |
| Cooling: | Air cooling | Same | Same |
| Protection against
matter/water | IPX1 | / | IPX1 |
| Dimensions: | 460 mm × 460 mm ×
15 mm | 916.9 mm × 486.4 mm ×
42.8 mm | 460 mm × 460 mm × 15mm |
| Frame rate | / | 3.5fps@1×1
15fps@2×2
25fps@4×4 | 5fps@1×1
20fps@2×2
30fps@3×3 |
| Operation: | Temperature: +5 ~
+35°C
Humidity: 30 ~ 80%
(Non-Condensing)
Atmospheric pressure:
70 ~ 106 | Temperature: +10 ~
+40°C
Humidity: 30 ~ 75%
(Non-Condensing)
Atmospheric pressure: 700
~ 1060 hPa | Temperature: +10 ~ +35°C
Humidity: 20 ~ 90%
(Non-Condensing)
Atmospheric pressure: 700 ~
1060 mbar
Altitude: Max. 3000 meters |
| Item | Predicate Device:
Venu1717X Digital
Flat Panel Detector | Reference Device:
CareView 3600RF X-ray
Flat Panel Detector | Proposed Device:
Mercu1717V Digital Flat Panel
Detector |
| Storage and
Transportation:
( detector ) | Temperature: 10 ~ +55℃
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure:
70 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +55℃
Humidity: 10 ~ 90%
(Non-Condensing)
Atmospheric pressure: 700
~ 1060 hPa
Altitude: Max. 3000 meters | Temperature: -10 ~ +55℃
Humidity: 10 ~ 95%
(Non-Condensing)
Atmospheric pressure: 700 ~
1060 mbar
Altitude: Max. 3000 meters |
| Software | iDetector | CareRay software
provides a set of
predefined APIs
( Application
Programming
Interfaces ) , an adapter
layer between a CareView
3600RF detector and an
upstream program on the
client side, commonly
known as DROC (Digital
Radiography Operator
Console )
DROC communicates
with the CareRay | The Mercu1717V Digital Flat
Panel Detector is supported by
software, named iRayDR.
The iRayDR used for getting
digital X-ray radiography
images from the digital flat
panel detectors. iRay DR is
used to handle the DICOM
protocol (DICOM 3.0). iRay
DR has many functions such as
patient registration, image
acquisition, image display,
image processing and image
archiving. |
| | Predicate Device: | Reference Device: | Proposed Device: |
| Item | Venu1717X Digital
Flat Panel Detector | CareView 3600RF X-ray
Flat Panel Detector | Mercu1717V Digital Flat Panel
Detector |
| | | detectors via APIs. In
general, APIs are provided
in the form of DLL
(Dynamic-Link
Libraries) files. The
upstream program imports
these DLL files and calls
relevant API commands to
manipulate a CareView
3600RF detector-query
status, select application
mode, calibrate detector,
acquire images, and
preprocess images-without
caring about the
implementation details of
the algorithm or workflow
under the hood. | Image processing refers to some
post-processing tools for the
acquired image, including three
parts of the common tools, the
image post-processing tools and
the measurement tools.
Common tools: zoom, rotate,
etc.
Post-processing tools: adjust
image contrast, brightness, etc.
Measurement tools: line
measurement, angle
measurement.
iRayDR software is of
Moderate level of concern. |
8. Technological Characteristic [21 CFR 807.92(a)(6)]
7
iRay Technology Taicang Ltd.
[510(k)] Application
8
iRay Technology Taicang Ltd.
[510(k)] Application
9
10
iRay Technology Taicang Ltd.
[510(k)] Application
9. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification: Energy range: 40
150kVp mA range: 101000mA (depending on the generator power) ms range: 106300ms to produce 0.11000mAs (depending on the generator power)
- Recommended Generator Specification: Energy range: 40
11
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 the distributor or iRay's service office.
-
- Peripheral hardware: Mercu1717V connected via wired communication.
| Operating System: | Windows 10, 64bit |
|---|---|
| CPU: | Intel Core i5 8400 2.8G |
| Memory: | 16G DDR4 |
| Hard Disk: | 1T SSD |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
-
- X-ray exposure mode
The digital flat panel detector gets ready to output image after it receive signal form high-voltage generator. The digital flat panel detector stops outputting image when there is no signal from high-voltage generator
- X-ray exposure mode
10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
- Electrical Safety and EMC testing: 1) Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
-
- Biological Evaluation: The digital flat panel detector is not intended to be touched by patient, so evaluation of bio-compatibility is not necessary.
-
- Non-clinical Considerations:
12
The non-clinical studies have been performed and the results have shown that the Mercu1717V digital flat panel detector is substantially equivalent to the predicate devices on the Market (K221714)
Parameter about image quality is equal to or better than predicate device parameter According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iRayDR 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:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices',
- Clinical Consideration:
11. Conclusion [21 CFR 807.92(b)(3)]
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 Mercu1717V is substantially equivalent to predicate device with regards to safety and effectiveness.