Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Device Description

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C detectors are 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 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Focus 43C Detector" and "TRIMAX 43C Detector". The submission focuses on demonstrating substantial equivalence to a predicate device, the "Wireless Digital Flat Panel Detector (Mars1717XF-CSI, K183713)".

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it compares the technical characteristics of the proposed device to the predicate device to demonstrate substantial equivalence. The performance metrics are generally presented as improvements or minor changes compared to the predicate.

Characteristic	Predicate Device (Mars1717XF-CSI)	Proposed Device (Focus 43C / TRIMAX 43C)	Evaluation/Comment (Implied Acceptance)
Intended Use	Same as proposed	Same as predicate	Substantially equivalent. Indications for use explicitly include adult and pediatric patients.
Classification Name	Stationary x-ray system	Same	Substantially equivalent.
Product Code	MQB	Same	Substantially equivalent.
Regulation Number	21 CFR 892.1680	Same	Substantially equivalent.
X-Ray Absorber	CsI	Same	Substantially equivalent.
Installation Type	Wireless, Portable	Same	Substantially equivalent.
Readout Mechanism	Thin Film Transistor	Same	Substantially equivalent.
Image Matrix Size	2832 × 2836 pixels	3072 × 3072 pixels	Improved (higher resolution), considered substantially equivalent as improvement.
Pixel Pitch	150 µm	139 µm	Improved (smaller pixel size), considered substantially equivalent as improvement.
ADC Digitization	16 bit	Same	Substantially equivalent.
Effective Imaging Area	424.8 mm × 425.4 mm	427 mm × 427 mm	Slightly larger, considered substantially equivalent.
Spatial Resolution	3.3 lp/mm	3.6 lp/mm	Improved (higher resolution), considered substantially equivalent as improvement.
Modulation Transfer Function (MTF) @ 1 lp/mm	0.49	0.61	Improved, considered substantially equivalent as improvement.
Detective Quantum Efficiency (DQE) @ 1 lp/mm (RQA5, 2.5µGy)	0.40	0.46	Improved, considered substantially equivalent as improvement.
Power Consumption	Max. 20W	Max. 20W	Substantially equivalent.
Communications (Wireless functionality)	IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)	IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz) + Wired	Improved wireless standard (added 'ac') and wired option, considered substantially equivalent as an enhancement.
Imaging Protect Plate	N/A (not specified but presumed)	Carbon Fiber Plate	Specified, likely similar or improved over predicate.
Cooling	Air cooling	Same	Substantially equivalent.
Dimensions	460 mm × 460 mm × 15 mm	460 mm × 460 mm × 15.2 mm	Minor dimensional change, considered substantially equivalent.
Operation Temperature	+5 ~ +30 °C	+5 ~ +35 °C	Slightly wider acceptable range, considered substantially equivalent.
Operation Humidity	10 ~ 80% (Non-Condensing)	10 ~ 90% (Non-Condensing)	Slightly wider acceptable range, considered substantially equivalent.
Storage Temperature	-20 ~ +50 °C	-20 ~ +55 °C	Slightly wider acceptable range, considered substantially equivalent.
Storage Humidity	10 ~ 90% (Non-Condensing)	5 ~ 95% (Non-Condensing)	Slightly wider acceptable range, considered substantially equivalent.
Software (iRay SDK)	"intend to supply API interface for DR system manufacturers... unchanged from the predicate device."	Same	Substantially equivalent. No change to the software API provided to DR system manufacturers.

The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The document asserts that the proposed devices meet this through direct comparison and noting improvements where applicable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical images or patient data for evaluating the device's diagnostic performance. The evaluation is primarily focused on non-clinical performance testing and comparison of technical specifications to the predicate device.

No specific sample size for a test set of images or patient data is mentioned.
Data provenance (country of origin, retrospective/prospective) is not applicable or provided for such a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. The submission does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The evaluation is based on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This information is not applicable as no diagnostic test set or adjudication process is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned. This device is a digital X-ray detector, not an AI-powered diagnostic tool, so such a study would not typically be performed or described in this type of submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI algorithm. The device is a digital X-ray detector. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not relevant to this submission, as it focuses on the technical performance specifications of the X-ray detector rather than its diagnostic accuracy in interpreting images. The "ground truth" for the device's performance characteristics (e.g., spatial resolution, MTF, DQE) would be established through physical measurements and standardized test phantoms according to industry standards.

8. The Sample Size for the Training Set

No training set is mentioned as this device is an X-ray detector, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned or relevant for this device.

Summary of Device Performance Demonstration:

The submission demonstrates substantial equivalence primarily through:

Comparison of Technical Specifications: A detailed table comprehensively compares various technical characteristics, showing that the proposed device is either similar to or improved upon the predicate device (e.g., higher image matrix size, smaller pixel pitch, better spatial resolution, MTF, and DQE).
Non-Clinical Performance Testing:
- Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2, with results meeting standard requirements.
- Biological Evaluation: Materials contacting skin evaluated per ISO 10993-1, with results assuring safety "the same as the predicate device."
- Other Non-Clinical Considerations: These studies showed that non-clinical considerations mentioned in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" are substantially equivalent to the predicate. This likely includes aspects like image quality, dose performance, and environmental testing.
Clinical Consideration: The document explicitly states that "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." It also states, "There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device." This implies that while no formal clinical study is presented, the technical improvements are not expected to negatively impact clinical performance, and the output images are comparable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K200622

Trade/Device Name: Focus 43C Detector, TRIMAX 43C Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2020 Received: March 9, 2020

Dear Meng Li:

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.

April 1, 2020

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200622

Device Name Focus 43C Detector TRIMAX 43C Detector

Indications for Use (Describe)

There are no differences between the 2 models except the model name and trade mark.

TVDE of USe (Select One of Doll). as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 6

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K200622

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]

Jan. 8th, 2020

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 andTechnological 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:	Focus 43C DetectorTRIMAX 43C Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Focus 43CTRIMAX 43C
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:	Mars1717XF-CSI
Product Code:	MQB
Device Class:	Class II
Classification Name:	Stationary x-ray system
FDA 510 (k) #:	K183713

5. Description of the Device [21 CFR 807.92(a)(4)]

The sensor plate of Focus 43C and TRIMAX 43C detectors are 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 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. 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.

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6. Intended Use [21 CFR 807.92(a)(5)]

6.1. Indications for use

Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography, dental applications. There are no differences between the 2 models except the model name and trade mark.

6.2. Suitable patient

They are 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:Wireless Digital Flat PanelDetector	Proposed Device:Wireless Digital Flat PanelDetector
510(K)Number	K183713	K200622
Intended Use	The Mars1717XF-CSI WirelessDigital Flat Panel Detector isindicated for digital imaging	same
Item	Predicate Device:Wireless Digital Flat PanelDetector	Proposed Device:Wireless Digital Flat PanelDetector
	solution designed for providinggeneral radiographic system in allgeneral-purpose diagnosticprocedures.
IndicationsforUse	Mars1717XF-CSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic diagnosis ofhuman anatomy.It is intended to replaceradiographic film/screen systemsin all general-purpose diagnosticprocedures. This device is notintended for mammography ordental applications.We understand the Agency hasbecome aware of situations wheresolid state detectors inserted intoradiographic systems adverselyimpacted device performance dueto improper integration(reference:http://www.fda.gov/downloads/MedicalDevices/Resourc	Same with Mars1717XF-CSI,additionally, in theconsideration of patient size(i.e., height, weight, body partthickness) and usable doserange, the detector could beused for general X raydiagnosis of usual body partfor adults and pediatricpatients..
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat Panel	Wireless Digital Flat Panel
	Detector	Detector
	esforYou/Industry/UCM385149.p
	df ).

	Below is a summary of the
	information from the
	Mars1717XF-CSI user manuals
	covering key electromechanical
	and computer requirements
	needed for X-ray system interface
	and integration.
	1. Mechanical interface
	requirements.
	2. Computer requirements
	3. Data communication interface
	requirements
	4. Electrical power requirements
	5. X-ray trigger interface
	requirements

	Neither the Mars1717XF-CSI
	detector nor its software act as an
	X-ray generator controller, and
	therefore, the device is not subject
	to Electronic Product Radiation
	Control (EPRC) performance
	standards and reporting
	requirements.
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat Panel Detector	Wireless Digital Flat Panel Detector
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:	2832× 2836 pixels	3072 × 3072 pixels
Pixel Pitch:	150μm	139µm
ADC Digitization	16 bit	Same
Effective Imaging Area:	424.8 mm × 425.4 mm	427 mm × 427 mm
Spatial Resolution:	3.3lp/mm	3.6lp/mm
Modulation Transfer Function (MTF)	0.49 at 1 lp/mm	0.61 at 1 lp/mm
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
DetectiveQuantumEfficiency(DQE)	0.40 at 1 lp/mm (RQA5, 2.5µGy)	0.46 at 1 lp/mm (RQA5, 2.5µGy)
PowerConsumption:	Max. 20W	Max. 20W
Communications:(Wirelessfunctionality)	Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)	a) Wired (only for service) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz / 5 GHz)
	Imaging protectPlate:	Carbon Fiber Plate
Cooling:	Air cooling	Same
Dimensions:	460 mm × 460 mm × 15 mm	460 mm × 460 mm × 15.2 mm
Operation:	Temperature: +5 ~ +30 °C	Temperature: +5 ~ +35 °C
	Humidity: 10 ~ 80%(Non-Condensing)	Humidity: 10 ~ 90%(Non-Condensing)
	Atmospheric pressure: 70 ~ 106 kPa	Atmospheric pressure: 70 ~ 106 kPa
	Altitude: Max. 3000 meters	Altitude: Max. 3000 meters
Storage andTransportation:	Temperature: -20 ~ +50 °CHumidity: 10 ~ 90%	Temperature: -20 ~ +55 °CHumidity: 5 ~ 95%
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat Panel	Wireless Digital Flat Panel
( detector )	Detector	Detector
	(Non-Condensing)	(Non-Condensing)
	Atmospheric pressure: 70 ~ 106 kPa	Atmospheric pressure: 70 ~ 106 kPa
	Altitude: Max. 3000 meters	Altitude: Max. 3000 meters
	iRay SDK(include iDetector) is
	intend to supply API interface for
	DR system manufacturers. DR
Software	system manufacturer control the detector by SDK interface. SDK is not intended to use directly by other users beside DR system manufacturers.	Same
	1. Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices;
	2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];	Same with Mars1717XF-CSI, additionally:Guidance for "Premarket Assessment of Pediatric Medical Devices";Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications".
Utilized FDAguidancedocuments	3. Content of PremarketSubmissions for Managementof Cybersecurity in MedicalDevices;4. Radio Frequency WirelessTechnology in MedicalDevices.

7. Technological Characteristic [21 CFR 807.92(a)(6)]

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iRay Technology Taicang Ltd.

[510(k)] Application

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8. System requirements to operate with other radiographic system components

1. Recommended Generator Specification:
  Energy range: 40~150keV

mA range: 10~1000mA (depending on the generator power)

ms range: 10~~6300ms to produce 0.1~~1000mAs (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.

1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Focus 43C and TRIMAX 43C detectors connected via wireless communication.
  Minimum computer hardware requirement is:
Windows 10 Professional 64 bit
Intel Core(TM)2 Duo CPU E7400 @ 2.80GHz or equivalent AMD CPU
4GB DRAM memory
· 200GB hard disk
· Ethernet card 100 Mbp/s (Dual Ethernet cards required)
CD/DVD writer
17" display of 1280x800 resolution.
2 USB ports
1. X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Focus 43C and TRIMAX 43C. 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.

SECTION 6 - 10 of 12

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9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

1. Electrical Safety and EMC testing:
  Electrical, mechanical, environmental safety and performance testing 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.
1. 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.
1. Non-clinical Considerations:
  One modification from the predicate device to Focus 43C and TRIMAX 43C is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, predicate device has higher wireless transmission speed.

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 (Mars1717XF-CSI, K183713).

1. 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 pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence.

There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device.

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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 43C and TRIMAX 43C are substantially equivalent to predicate device with regards to safety and effectiveness.

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Regulation Number and Section

§ 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.