(145 days)
Not Found
No
The document describes a standard digital X-ray detector and its components. There is no mention of AI, ML, or any advanced image processing techniques that would typically involve these technologies. The processing described is basic signal conversion and composition.
No
This device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device is indicated for "general radiographic diagnosis for human anatomy," which clearly states its diagnostic purpose.
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 includes software (SDK), the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Focus HD 35 Detector is a digital X-ray detector. Its primary function is to convert X-rays into digital images of the human anatomy. This is an in vivo imaging process, meaning it is performed on a living organism.
- Intended Use: The intended use is for general radiographic diagnosis, which involves capturing images of internal structures of the body using X-rays. This is not an in vitro test.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Focus HD 35 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 generalpurpose diagnostic procedures. The device is not intended for mammography or dental applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
Focus HD 35 Detector is a 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: 35cm×43cm.
The sensor plate of Focus HD 35 Detector 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 Focus HD 35 Detector 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.
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: 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 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: Main modification from the predicate device is DC input port change (from 4 pin port to 10 pin port). This DC input port is only designed and applicable for DR system manufacturer. 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-clinical consideration of predicate device on the Market (Mars1417X, K210316).
-
- 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. There is no any change about clinical performance from predicate device.
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.
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March 29, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's name on the right. The seal features an eagle-like figure, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "ADMINISTRATION" appearing in a smaller font size below the rest of the name.
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: K213646
Trade/Device Name: Focus HD 35 Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 20, 2021 Received: November 4, 2021
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 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
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Indications for Use
510(k) Number (if known) K213646
Device Name Focus HD 35 Detector
Indications for Use (Describe)
Focus HD 35 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 generalpurpose 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 G) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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iRay Technology Taicang Ltd.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
October 13, 2021
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: | Focus HD 35 Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus HD 35 |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
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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: | Mars1417X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K210316 |
5. Description of the Device [21 CFR 807.92(a)(4)]
Focus HD 35 Detector is a 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: 35cm×43cm.
The sensor plate of Focus HD 35 Detector 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 Focus HD 35 Detector 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.
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.
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6. Intended Use [21 CFR 807.92(a)(5)]
6.1. Indications for use
Focus HD 35 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 generalpurpose 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 Focus HD 35 Detector works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.
| Item | Predicate Device:
Mars1417X Wireless Digital
Flat Panel Detector | Proposed Device:
Focus HD 35 Detector |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 510(K) Number | K210316 | |
| Intended Use | Mars1417X Wireless Digital
Flat Panel Detector is
indicated for digital imaging
solution designed for
providing general
radiographic system in all
general-purpose diagnostic
procedures. | same |
| Item | Predicate Device:
Mars1417X Wireless Digital
Flat Panel Detector | Proposed Device:
Focus HD 35 Detector |
| Indications for Use | Mars1417X 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 |
| Image Matrix Size: | $3500 \times 4300$ pixels | Same |
| Item | Predicate Device:
Mars1417X Wireless Digital
Flat Panel Detector | Proposed Device:
Focus HD 35 Detector |
| Pixel Size: | 100μm | Same |
| ADC Digitization | 16 bit | Same |
| Effective
Imaging
Area: | 350.0 mm × 430.0 mm | Same |
| Spatial Resolution: | Min. 4.3lp/mm | 5.0 lp/mm |
| Modulation
Transfer
Function
(MTF) | 0.65 at 1 lp/mm | Same |
| Detective
Quantum
Efficiency
(DQE) | 0.54 at 1 lp/mm (RQA5,
2.5μGy) | Same |
| Power
Consumption: | Max. 19W | Max.35.5W |
| 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: | 384 mm × 460 mm × 15 mm | Same |
| Item | Predicate Device:
Mars1417X Wireless Digital
Flat Panel Detector | Proposed Device:
Focus HD 35 Detector |
| Detector IP grade | IP56 | Same |
| Power input port | 4 pin port | 10 pin port |
| Surface pressure | Uniform load: 300 kg over
the whole area of the surface; | Uniform load: 300 kg over the
whole area of the surface; |
| | Local load: 150 kg on an
area 4 cm diameter of center | Local load: 100 kg on an area 4
cm diameter of center |
| Operation: | Temperature: +10 ~ +35°C | Temperature: +5 ~ +35°C |
| | Humidity: 5 ~ 90%
(Non-Condensing) | Humidity: 5 ~ 90%
(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| | | |
| Storage and
Transportation:
( detector ) | Temperature: -20 ~ +55°C | Temperature: -20 ~ +55°C |
| | Humidity: 5 ~ 95%
(Non-Condensing) | Humidity: 5 ~ 95%
(Non-Condensing) |
| | Atmospheric pressure: 60 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| Software | 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 intend
to use directly by other users | Same |
| Item | Predicate Device: | Proposed Device: |
| | Mars1417X Wireless Digital
Flat Panel Detector
beside DR system
manufacturers. | Focus HD 35 Detector |
| Utilized FDA
guidance
documents | 1. Guidance for the
Submission of 510(k)'s
for Solid State X-ray
Imaging Devices;
2. The 510(k) Program:
Evaluating Substantial
Equivalence in Premarket
Notifications[510(k)];
3. Content of Premarket
Submissions for
Management of
Cybersecurity in Medical
Devices;
4. Radio Frequency
Wireless Technology in
Medical Devices;
5. Guidance for “Premarket
Assessment of Pediatric
Medical Devices”;
6. Guidance for “Pediatric
Information for X-ray
Imaging Device
Premarket Notifications”. | Same |
| Item | Predicate Device:
Mars1417X Wireless Digital
Flat Panel Detector | Proposed Device:
Focus HD 35 Detector |
| | 7. The Special 510(k)
Program
8. Design Control Guidance
For Medical Device
Manufacturers
9. Appropriate Use of
Voluntary Consensus
Standards in Premarket
Submissions for Medical
Devices | |
7. Technological Characteristic [21 CFR 807.92(a)(6)]
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7
8
9
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8. System requirements to operate with other radiographic system components
-
- 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 compatibility issue for other generators, please contact the distributor or manufacturer's service office.
-
- Application Program Interface (API) for system integration manufacturer Minimum configuration: Focus HD 35 Detector connected via wireless communication.
| Operating System: | Windows embedded |
|---|---|
| CPU: | Intel Core i3- 8100 3.6GHz 4C 65W |
| Memory: | 16GB (2x8GB) DDR4 2666 DIMM |
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Hard Disk: 1TB
X-ray exposure mode 3)
The AED trigger module is a unit can connect X-ray signal in the Focus HD 35 Detector. 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.
Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] 9.
- 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 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:
Main modification from the predicate device is DC input port change(from 4 pin port to 10 pin port ) . This DC input port is only designed and applicable for DR system manufacturer.
- Non-clinical Considerations:
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-clinical consideration of predicate device on the Market (Mars1417X, K210316).
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with
- Clinical Consideration:
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those of predicate device. There is no any change about clinical performance from predicate device.
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 Focus HD 35 Detector is substantially equivalent to predicate device with regards to safety and effectiveness.