Focus 35C and TRIMAX 35C 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 or dental applications. There are no differences between the 2 models except the model name and trade mark.

Device Description

Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) 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: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark. The sensor plate of Focus 35C and TRIMAX 35C 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 35C and TRIMAX 35C 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 intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the iRay Technology Taicang Ltd. Focus 35C Detector and TRIMAX 35C Detector. This submission asserts substantial equivalence to a predicate device (Mars1417XF-CSI, K182551). For devices like X-ray detectors, acceptance criteria often revolve around physical performance specifications and safety, rather than diagnostic accuracy as would be the case for an AI diagnostic device. The study described focuses on demonstrating that the proposed devices meet these technical and safety standards, and are substantially equivalent to the predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might typically expect for a diagnostic AI device (e.g., Sensitivity, Specificity, AUC). Instead, it presents a comparison of technological characteristics between the proposed device (Focus 35C / TRIMAX 35C) and its predicate device (Wireless Digital Flat Panel Detector, Mars1417XF-CSI). The acceptance is implied by demonstrating that the proposed device performs at least as well as or better than the predicate for key technical specifications, and meets relevant industry standards.

Here's a table compiled from the "Technological Characteristic" section comparing the proposed device to the predicate device, which implicitly serves as the baseline for performance acceptance:

Item	Predicate Device (Mars1417XF-CSI)	Proposed Device (Focus 35C / TRIMAX 35C)	Implied Acceptance: Proposed device meets or exceeds predicate performance standards.
Image Matrix Size	2336 × 2836 pixels	2304 × 2800 pixels	Similar, minor difference
Pixel Pitch	150 µm	150 µm	Same
ADC Digitization	16 bit	16 bit	Same
Effective Imaging Area	350.4 mm × 425.4 mm	345.6 mm × 420.0 mm	Similar, minor difference
Spatial Resolution	Min. 3.3 lp/mm	Min. 3.3 lp/mm	Same
Modulation Transfer Function (MTF)	0.5 at 1 lp/mm	0.61 at 1 lp/mm	Better than predicate
Detective Quantum Efficiency (DQE)	0.37 at 1 lp/mm (RQA5, 2.5 µGy)	0.42 at 1 lp/mm (RQA5, 2.5 µGy)	Better than predicate
Power Consumption	Max. 19W	Max. 18W	Better than predicate (lower)
Communication (Wireless functionality)	Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz)	Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE 802.11a/b/g/n/ac (2.4 GHz / 5 GHz)	Better than predicate (includes 'ac' standard and wired option)
Operation Temperature	+5 ~ +30 °C	+5 ~ +35 °C	Slightly wider range
Operation Humidity	10 ~ 80% (Non-Condensing)	10 ~ 90% (Non-Condensing)	Slightly wider range
Storage/Transportation Humidity	10 ~ 90% (Non-Condensing)	5 ~ 95% (Non-Condensing)	Wider range

Study Proving Acceptance:

The study proving acceptance is primarily a non-clinical performance study and safety testing demonstrating that the proposed devices (Focus 35C and TRIMAX 35C) are substantially equivalent to the predicate device.

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."
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: "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 (Mars1417XF-CSI, K182551)."
Clinical Consideration: "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device." This suggests an informal comparison of image quality, likely by engineers or qualified personnel during the non-clinical evaluation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies were non-clinical performance and safety tests, not clinical studies involving patient data in the typical sense for evaluating diagnostic performance. The comparisons were primarily based on technical specifications and output image quality (likely using phantoms or test targets, rather than a "test set" of patient images with ground truth diagnoses).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is an X-ray detector, not an AI diagnostic algorithm. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for its technical performance would be the specifications and measurements from calibration and performance tests. The statement "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device" implies an informal assessment of image quality, likely by qualified personnel (engineers, physicists, or potentially radiologists if consulted for image perception) rather than a formal expert consensus for a diagnostic task.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. This is not a study requiring adjudication of diagnostic findings.

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

Not applicable and not provided. This is an X-ray detector, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable and not provided. This is an X-ray detector, not an AI algorithm. Its performance is measured by its physical and technical capabilities to produce an image.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense. For this device, the "ground truth" for its performance evaluation comes from:

Engineering specifications and measurements (e.g., spatial resolution, MTF, DQE).
Compliance with international safety and electromagnetic compatibility standards (IEC/ES 60601-1, IEC 60601-1-2).
Biocompatibility testing against a standard (ISO 10993-1).
Comparison of image characteristics to the predicate device, likely using phantoms or standard test patterns.

8. The sample size for the training set

Not applicable and not provided. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable and not provided. This is not an AI device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.

iRay Technology Taicang Ltd. Meng Li Registration & Regulatory Affairs Engineer No.33 Xinggang Rd., Taicang Port Economic & Technological Development Zone TAICANG, Jiangsu 215434 CHINA

Re: K192512

Trade/Device Name: Focus 35C Detector, Trimax 35C Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: September 1, 2019 Received: September 12, 2019

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.

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.

October 16, 2019

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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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192512

Device Name Focus 35C Detector TRIMAX 35C Detector

Indications for Use (Describe)

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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SECTION 6 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K192512

(As Required by 21 CFR 807.92)

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

October 10th, 2019

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:	Meng Li
Phone:	0512-53690872
Fax:	0512-53690872
Email:	meng.li@iraychina.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name:	Focus 35C Detector
	TRIMAX 35C Detector
Common Name:	Solid State X-Ray Imager
Model Name:	Focus 35C
	TRIMAX 35C
Classification Name:	Stationary X-Ray System
Product Code:	MQB
Regulation Number:	21 CFR 892.1680
Device Class:	Class II

1. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]

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Manufacturer:	iRay Technology Taicang Ltd.
Trade Name:	Wireless Digital Flat Panel Detector
Model Name:	Mars1417XF-CSI
Product Code:	MQB
Classification Name:	Stationary X-Ray System
FDA 510 (k) #:	K182551

The identification predicates within this submission are as follows:

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

The sensor plate of Focus 35C and TRIMAX 35C 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 35C and TRIMAX 35C 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 intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

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

6.1. Indications for use

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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	K182551	To be assigned
Intended Use	The Mars1417XF-CSI WirelessDigital Flat Panel Detector isindicated for digital imagingsolution designed for providinggeneral radiographic system inall general purpose diagnosticprocedures.	Same with Mars1417XF-CSI,additionally, in the considerationof patient size (i.e., height,weight, body part thickness) andusable dose range, the detectorcould be used for general X raydiagnosis of usual body part for
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
	We understand the Agency hasbecome aware of situationswhere solid state detectorsinserted into radiographicsystems adversely impacteddevice performance due toimproper integration(reference:http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf ).Below is a summary of theinformation from theMars1417XF-CSI user manualscovering key electromechanicaland computer requirementsneeded for X-ray systeminterface and integration.1. Mechanical interfacerequirements.2. Computer requirements3. Data communication interfacerequirements4. Electrical power requirements5. X-ray trigger interfacerequirements	both adults and pediatricpatients.
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
	Neither the Mars1417XF-CSIdetector nor its software act asan X-ray generator controller,and therefore, the device is notsubject to Electronic ProductRadiation Control (EPRC)performance standards andreporting requirements.
ClassificationName	Stationary X-ray system	Same
Product Code	MQB	Same
RegulationNumber	21 CFR 892.1680	Same
Panel:	Radiology	Same
Classification:	II	Same
X-Ray Absorber(Scintillator):	CsI	Same
InstallationType:	Wireless, Portable	Same
ReadoutMechanism:	Thin Film Transistor	Same
Image MatrixSize:	2336× 2836 pixels	2304 × 2800 pixels
Pixel Pitch:	$150\mu m$	Same
ADCDigitization	16 bit	Same
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
EffectiveImaging Area:	$350.4 mm \times 425.4 mm$	$345.6 mm \times 420.0 mm$
SpatialResolution:	Min. 3.3lp/mm	Same
ModulationTransferFunction(MTF)	0.5 at 1 lp/mm	0.61 at 1 lp/mm
DetectiveQuantumEfficiency(DQE)	0.37 at 1 lp/mm (RQA5,2.5μGy)	0.42 at 1 lp/mm (RQA5,2.5μGy)
PowerConsumption:	Max. 19W	Max. 18W
Communications:(Wirelessfunctionality)	Wireless: IEEE 802.11a/b/g/n(2.4 GHz / 5 GHz)	a) Wired (only for service) :Gigabit Ethernet(1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4 GHz /5 GHz)
Imaging protectPlate:	Carbon Fiber Plate	Same
Cooling:	Air cooling	Same
Dimensions:	$384 mm \times 460 mm \times 15 mm$	Same
Operation:	Temperature: +5 ~ +30 °CHumidity: 10 ~ 80%(Non-Condensing)	Temperature: +5 ~ +35 °CHumidity: 10 ~ 90%(Non-Condensing)
	Predicate Device:	Proposed Device:
Item	Wireless Digital Flat PanelDetector	Wireless Digital Flat PanelDetector
	Atmospheric pressure: 70 ~ 106 kPa	Atmospheric pressure: 70 ~ 106 kPa
	Altitude: Max. 3000 meters	Altitude: Max. 3000 meters
	Temperature: -20 ~ +50°C	Temperature: -20 ~ +55°C
Storage andTransportation:( detector )	Humidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters	Humidity: 5 ~ 95%(Non-Condensing)Atmospheric pressure: 70 ~ 106 kPaAltitude: Max. 3000 meters
Software	iRay SDK(include iDetector) isintend to supply API interfacefor DR system manufacturers.DR system manufacturer controlthe detector by SDK interface.SDK is not intend to use directlyby other users beside DR systemmanufacturers.	Same
Utilized FDAguidancedocuments	1. Guidance for the Submissionof 510(k)'s for Solid StateX-ray Imaging Devices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement of	Same with Mars1417XF,additionally:1. Guidance for “PremarketAssessment of PediatricMedical Devices”;2. Guidance for “PediatricInformation for X-rayImaging Device PremarketNotifications”.
Item	Predicate Device:	Proposed Device:
	Wireless Digital Flat Panel	Wireless Digital Flat Panel
	Detector	Detector
	Cybersecurity in MedicalDevices;
	4. Radio Frequency WirelessTechnology in MedicalDevices.

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

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8. System requirements to operate with other radiographic system components

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

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 35C and TRIMAX 35C detectors connected via wireless communication.

Operating System:	Windows XP/7 32/64bit
CPU:	Intel Core i5 3.6G
Memory:	8G DDR3
Hard Disk:	640 G
LAN Card:	Intel Pro EXP9301CT PROGigabit Network Adapter with PCIe interface

1. X-ray exposure mode
  The AED trigger module is a unit can connect X-ray signal in the Focus 35C and TRIMAX 35C. Once there is X-ray generator exposure exist, the inner trigger

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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.

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

Electrical Safety and EMC testing: 1)
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 35C and TRIMAX 35C 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 (Mars1417XF-CSI, K182551).

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 dimensions of the image

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receptor with otherwise identical materials if non-clinical information is sufficient to support the substantial equivalence.

There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the 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 35C and TRIMAX 35C are substantially equivalent to predicate device with regards to safety and effectiveness.

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.