(38 days)
Not Found
No
The description focuses on the hardware components and basic image processing for converting X-ray signals to digital images. There is no mention of AI, ML, or advanced algorithms for image analysis or interpretation.
No
The device is used for diagnostic imaging (converting X-rays to digital images for diagnosis), not for treating a disease or condition.
Yes
The device is indicated for digital imaging solutions "designed to provide general radiographic diagnosis for human anatomy."
No
The device description clearly states it is a "wireless digital flat panel detector" with a "TFT/PD image sensor flat panel" and "scanning and readout electronics," indicating it is a hardware device that converts X-rays to digital images. While it uses software (iRay SDK) to interface with a PC, the core medical device is the physical detector.
Based on the provided information, the Luna 1012X wireless digital flat panel detector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- 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 using X-rays, which is an in vivo (within the living body) process, not an in vitro (outside the living body) process.
- Device Description: The description details how the device converts X-rays to digital images of the human anatomy. This aligns with diagnostic imaging, not testing of samples outside the body.
- Input Imaging Modality: The input is X-ray, which is used for imaging the body directly.
- Anatomical Site: The device is used on "human anatomy".
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Luna 1012X does not perform this function.
Therefore, the Luna 1012X is a medical imaging device used for diagnostic radiology, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Luna 1012X wireless 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 (comma separated list FDA assigned to the subject device)
MOB
Device Description
Luna1012X Wireless Digital Flat Panel Detector (Hereinafter referred to as Luna1012X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 31.52cmx25.02cm. The sensor plate of Luna1012X 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 user interface. The major function of the Luna1012X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. 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. iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
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)
Electrical Safety and EMC testing: Electrical, mechanical, environmental safety according to IEC/ES 60601-1 and IEC 60601-2-54 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 materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device. Non-clinical Considerations: One main modification from the predicate device is flexible Amorphous Silicon TFT Panel. Another main modification is structure design with different IP grade. The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1013X, K220668). Clinical Consideration: Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance. labeling, quality-assurance program and software 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 may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 16, 2022
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: K221345
Trade/Device Name: Wireless Digital Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MOB Dated: June 13, 2022 Received: June 15, 2022
Dear Junjie Oian:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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 DHT 8B: Division of Radiological Imaging 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) K221345
Device Name Wireless Digital Flat Panel Detector
Indications for Use (Describe)
Luna 1012X wireless 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
iRay Technology Taicang Ltd.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
-
- Date Prepared [21 CFR 807.92(a)(1)]
April 7, 2022
- Date Prepared [21 CFR 807.92(a)(1)]
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 21543- | |
| 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: | Wireless Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Luna1012X |
| 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 Co., Ltd.
1 of 10
4
| Trade Name: | Wireless Digital Flat Panel Detector |
|---|---|
| Model Name: | Mars1013X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K220668 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Luna1012X Wireless Digital Flat Panel Detector (Hereinafter referred to as Luna1012X) is the kind of wireless digital flat panel detector. It supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 31.52cm×25.02cm
The sensor plate of Luna1012X 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 user interface.
The major function of the Luna1012X is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. 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.
iRay SDK(include iDetector) is intended to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to be used directly by other users beside DR system manufacturers.
5
6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Luna1012X wireless 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
When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
Mars1013X Wireless Digital
Flat Panel Detector | Proposed Device:
Luna1012X Wireless Digital
Flat Panel Detector | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 510(K) Number | K220668 | K221345 | |
| Intended Use | Mars1013X Wireless Digital
Flat Panel Detector is indicated
for digital imaging solution
designed for providing general
radiographic system in all
general-purpose diagnostic
procedures. | Same | |
| | Predicate Device: | Proposed Device: | |
| Item | Mars1013X Wireless Digital
Flat Panel Detector | Luna1012X Wireless Digital
Flat Panel Detector | |
| Indications for Use | Mars1013X wireless 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. | Same | |
| | 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 | Same |
| | Readout
Mechanism: | Thin Film Transistor | Same |
| | Sensor martial | Amorphous Silicon TFT Panel | Flexible
Amorphous Silicon TFT Panel |
| | Item | Predicate Device:
Mars1013X Wireless Digital
Flat Panel Detector | Proposed Device:
Luna1012X Wireless Digital
Flat Panel Detector |
| | Image Matrix Size: | 3318 × 2528 pixels | 3152×2502 pixels |
| | Pixel Size: | 100μm | Same |
| | ADC Digitization | 16 bit | Same |
| | Effective Imaging Area: | 331.8 mm × 252.8 mm | 315.2 mm×250.2 mm |
| Spatial Resolution: | Min. 4.3lp/mm | Same | |
| Modulation Transfer Function (MTF) | Min. 0.60 at 1 lp/mm | Same | |
| Detective Quantum Efficiency (DQE) | Min. 0.43 at 1 lp/mm
(RQA5, 2.5μGy) | Same | |
| Power Consumption: | Max. 18W | Same | |
| Communications:
(Wireless functionality) | a) Wired (only for service) : Gigabit Ethernet (1000BASE-T)
b) Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) | Same | |
| Imaging protect Plate: | Carbon Fiber Plate | Same | |
| Cooling: | Air cooling | Same | |
| Dimensions: | 362.1mm×269.2mm×15.5mm | 362.1mm×269.2mm×15mm | |
| Item | Predicate Device:
Mars1013X Wireless Digital
Flat Panel Detector | Proposed Device:
Luna1012X Wireless Digital
Flat Panel Detector | |
| Detector IP grade | IPX5 | IP67 | |
| Power input | adapter port input :
24Vdc 0.75A
Battery port input:
11.55Vdc 1.6A | Same | |
| Surface pressure | Uniform load: 150 kg over the whole area of the surface;
Local load: 100 kg on an area 4 cm diameter of center | Uniform load: 300 kg over the whole area of the surface;
Local load: 150 kg on an area 4 cm diameter of center | |
| Operation: | Temperature: +10 ~ +35 °C
Humidity: 5 ~ 90%
(Non-Condensing)
Atmospheric pressure: 70 ~ 106 kPa
Altitude: Max. 3000 meters | Same | |
| Storage and
Transportation:
( detector ) | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95%
(Non-Condensing)
Atmospheric pressure: 60 ~ 106 kPa
Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C
Humidity: 5 ~ 95% RH
(Non-Condensing)
Atmospheric pressure:
700~1060mbar
Altitude: Max. 3000 meters | |
| Software | SDK(include iDetector) is
intend to supply API interface
for DR system manufacturers.
DR system manufacturer | Same | |
| Item | Predicate Device:
Mars1013X Wireless Digital
Flat Panel Detector | Proposed Device:
Luna1012X Wireless Digital
Flat Panel Detector | |
| | control the detector by SDK
interface. SDK is not intended
to use directly by other users
beside DR system
manufacturers. | | |
| Applicable
guidance | Content of Premarket
Submissions for Management
of Cybersecurity in Medical
Devices Guidance for Industry
and Food and Drug
Administration Staff Document
Issued on: October 2, 2014 | Same | |
| | Pediatric Information for X-ray
Imaging Device Premarket
Notifications Guidance for
Industry and Food and Drug
Administration Staff Document
issued on November 28, 2017. | | |
| | Guidance for the Submission
of 510(k)s for Solid State X-
ray Imaging Devices Guidance
for Industry and Food and
Drug Administration Staff | | |
| | Predicate Device: | Proposed Device: | |
| Item | Mars1013X Wireless Digital
Flat Panel Detector | Luna1012X Wireless Digital
Flat Panel Detector | |
| | Document issued on:
September 1, 2016
Guidance for Industry and
FDA Staff Guidance for the
Content of Premarket
Submissions for Software
contained in Medical Devices,
Document issued on: May 11,
2005 Medical Devices,
Document issued on: May 11,
2005
Radio Frequency Wireless
Technology in Medical
Devices-Guidance for Industry
and FDA Staff | | |
- Technological Characteristic [21 CFR 807.92(a)(6)]
6
7
iRay Technology Taicang Ltd.
[510(k)] Application
8
9
10
System requirements to operate with other radiographic system components 8.
-
- Recommended Generator Specification:
Energy range: 40~150kVp
- 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
8 of 10
11
compatibility issue for other generators, please contact the distributor or iRay's service office.
-
- Application Program Interface (API) for system integration manufacturer Peripheral hardware: Luna1012X connected via wireless communication.
| Operating System: | Windows 7/10, 32/64bit |
|---|---|
| CPU: | Intel Core i7 3.6G |
| Memory: | ≥4 GB |
| Hard Disk: | 640 GB |
| LAN Card: | Intel Pro EXP9301CT PRO |
| Gigabit Network Adapter with PCIe interface |
-
- X-ray exposure mode
The AED trigger module is a unit can connect X-ray signal in the Luna1012X. Once there is X-ray generator exposure exist, the AED 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
9. 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 and IEC 60601-2-54 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 materials of the detector which contact operators' or patient's skin have 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:
-
- Non-clinical Considerations:
One main modification from the predicate device is flexible Amorphous Silicon TFT Panel. Another main modification is structure design with different IP grade
- Non-clinical Considerations:
9 of 10
12
The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1013X, K220668).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance. labeling, quality-assurance program and software 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 may not necessary for changes in the dimensions of the image receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.
- Clinical Consideration:
10. 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 Luna1012X is substantially equivalent to predicate device with regards to safety and effectiveness.