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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the iRay Technology Taicang Ltd. Focus HD 35 Detector. This document primarily focuses on establishing substantial equivalence to a predicate device (Mars1417X Wireless Digital Flat Panel Detector, K210316) rather than directly presenting a study proving that the device meets specific acceptance criteria related to a diagnostic task or clinical performance.

Medical device 510(k) clearances typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing. They do not usually involve clinical trials or studies like those required for novel AI/diagnostic devices that predict diagnoses or outcomes.

Therefore, many of the requested points regarding acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth, and training set information are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of what can be gleaned from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the technical specifications and safety standards required for substantial equivalence, rather than diagnostic performance metrics (e.g., sensitivity, specificity for disease detection). The comparison is primarily against the predicate device's specifications.

Characteristic	Acceptance Criteria (Predicate Device K210316)	Reported Device Performance (Focus HD 35 Detector)	Met/Not Met	Comments / Justification
Intended Use	General radiographic diagnosis for human anatomy (adult & pediatric), replacement for film/screen systems, not for mammography or dental.	Same	Met	Directly comparable Statement.
Indications for Use	Same as Intended Use.	Same	Met	Directly comparable Statement.
Classification Name	Stationary X-ray system	Same	Met	Directly comparable Statement.
Product Code	MQB	Same	Met	Directly comparable Statement.
Regulation Number	21 CFR 892.1680	Same	Met	Directly comparable Statement.
Panel	Radiology	Same	Met	Directly comparable Statement.
Classification	Class II	Same	Met	Directly comparable Statement.
X-Ray Absorber (Scintillator)	CsI	Same	Met	Directly comparable Statement.
Installation Type	Wireless, Portable	Same	Met	Directly comparable Statement.
Readout Mechanism	Thin Film Transistor	Same	Met	Directly comparable Statement.
Image Matrix Size	3500 x 4300 pixels	Same	Met	Directly comparable Statement.
Pixel Size	100μm	Same	Met	Directly comparable Statement.
ADC Digitization	16 bit	Same	Met	Directly comparable Statement.
Effective Imaging Area	350.0 mm x 430.0 mm	Same	Met	Directly comparable Statement.
Spatial Resolution	Min. 4.3 lp/mm	5.0 lp/mm	Met (Exceeded)	The proposed device offers higher spatial resolution, indicating improved performance.
Modulation Transfer Function (MTF)	0.65 at 1 lp/mm	Same	Met	Directly comparable Statement.
Detective Quantum Efficiency (DQE)	0.54 at 1 lp/mm (RQA5, 2.5μGy)	Same	Met	Directly comparable Statement.
Power Consumption	Max. 19W	Max. 35.5W	Different	This is a difference, but typically evaluated in terms of safety and functionality, not diagnostic performance. Addressed by electrical safety testing.
Communications (Wireless functionality)	Wired (Gigabit Ethernet), Wireless (IEEE 802.11a/b/g/n/ac)	Same	Met	Directly comparable Statement.
Imaging Protect Plate	Carbon Fiber Plate	Same	Met	Directly comparable Statement.
Cooling	Air cooling	Same	Met	Directly comparable Statement.
Dimensions	384 mm × 460 mm × 15 mm	Same	Met	Directly comparable Statement.
Detector IP grade	IP56	Same	Met	Directly comparable Statement.
Power input port	4 pin port	10 pin port	Different	Main modification from predicate device, but determined substantially equivalent after non-clinical studies.
Surface pressure (Uniform load)	300 kg over whole area	300 kg over whole area	Met	Directly comparable Statement.
Surface pressure (Local load)	150 kg on 4 cm diameter	100 kg on 4 cm diameter	Different	Proposed device has a lower local load capacity. The document implies this is acceptable for substantial equivalence without further explanation of the impact.
Operation Temperature	+10 ~ +35°C	+5 ~ +35°C	Different	Proposed device supports a wider temperature range, indicating improved or equivalent functionality.
Operation Humidity	5 ~ 90% (Non-Condensing)	Same	Met	Directly comparable Statement.
Operation Atmospheric pressure	70 ~ 106 kPa	Same	Met	Directly comparable Statement.
Operation Altitude	Max. 3000 meters	Same	Met	Directly comparable Statement.
Storage & Transportation Temperature	-20 ~ +55°C	Same	Met	Directly comparable Statement.
Storage & Transportation Humidity	5 ~ 95% (Non-Condensing)	Same	Met	Directly comparable Statement.
Storage & Transportation Atmospheric pressure	60 ~ 106 kPa	70 ~ 106 kPa	Different	Proposed device has a slightly reduced range. Implied acceptable for substantial equivalence.
Storage & Transportation Altitude	Max. 3000 meters	Same	Met	Directly comparable Statement.
Software	SDK (include iDetector) supplies API interface for DR system manufacturers.	Same	Met	Directly comparable Statement.
Electrical Safety	Meet IEC/ES 60601-1	All test results meet standard requirements.	Met	Stated as part of non-clinical testing.
EMC Testing	Meet IEC 60601-1-2	All test results meet standard requirements.	Met	Stated as part of non-clinical testing.
Biological Evaluation	Meet ISO 10993-1	Evaluation and test results assured safety.	Met	Stated as part of non-clinical testing.

2. Sample size used for the test set and the data provenance

Sample size used for the test set: Not applicable for a typical 510(k) submission based on technical equivalence. The "test set" here refers to the actual physical device and its components undergoing engineering and safety tests, not a dataset for diagnostic performance evaluation.
Data provenance: Not applicable. The data is from engineering and safety tests conducted on the physical device and from a comparison of specifications with the predicate. There is no mention of country of origin for clinical or image data, as such data is not the primary basis for this type of submission. The tests were likely conducted by the manufacturer or accredited labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is an X-ray detector, a hardware component. Its clearance is based on technical specifications, safety, and performance as an imaging capture device, not on its ability to produce a specific diagnosis from images or generate ground truth. There is no "ground truth" in the diagnostic sense being established for a test set of images within this submission.

4. Adjudication method for the test set

Not Applicable. As no clinical diagnostic performance study with images and ground truth is described, there's no adjudication method.

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. This is not an AI-powered diagnostic device. It's a digital X-ray detector. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.

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

No. This is a hardware device (X-ray detector), not an algorithm.

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

Not Applicable. For this hardware device submission, "ground truth" relates to physical measurements and compliance with engineering standards (e.g., spatial resolution, DQE, electrical safety standards). There is no clinical ground truth (pathology, expert consensus on images, etc.) associated with this submission.

8. The sample size for the training set

Not Applicable. This is a hardware device; no "training set" in the context of machine learning or AI is mentioned or relevant to its clearance.

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

Not Applicable. As no training set is mentioned, no ground truth for it was established.

Summary of the Study (as described in the 510(k) submission):

The "study" referenced in the document is primarily a technical assessment and comparison to establish substantial equivalence with a legally marketed predicate device (K210316, Mars1417X Wireless Digital Flat Panel Detector).

Methodology:
- Side-by-side comparison of technical specifications: The document provides tables comparing parameters like intended use, indications for use, physical dimensions, imaging characteristics (spatial resolution, MTF, DQE), environmental operating conditions, and interfaces between the proposed device and the predicate device.
- Non-clinical testing: This included:
  - Electrical safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2 standards.
  - Biological Evaluation: Materials contacting operators' or patient's skin evaluated with ISO 10993-1.
  - Functional performance testing: The document implies that areas with minor differences (e.g., power consumption, local load capacity, operating temperature range, atmospheric pressure range) were still considered substantially equivalent following non-clinical studies. The improved spatial resolution (5.0 lp/mm vs. Min. 4.3 lp/mm) was presented as a positive difference.
Conclusion: The manufacturer concluded that the Focus HD 35 Detector is substantially equivalent to the predicate device regarding safety and effectiveness, based on the non-clinical studies and comparison of technical characteristics. The main identified differences (DC input port, power consumption, local load, operating temperature range, storage/transportation atmospheric pressure) were implicitly determined not to raise new questions of safety or effectiveness.

Summary

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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

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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)

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)
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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 andTechnological 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.

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

6.1. Indications for use

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 DigitalFlat Panel Detector	Proposed Device:Focus HD 35 Detector
510(K) Number	K210316
Intended Use	Mars1417X Wireless DigitalFlat Panel Detector isindicated for digital imagingsolution designed forproviding generalradiographic system in allgeneral-purpose diagnosticprocedures.	same
Item	Predicate Device:Mars1417X Wireless DigitalFlat Panel Detector	Proposed Device:Focus HD 35 Detector
Indications for Use	Mars1417X wireless digitalflat panel detector is indicatedfor digital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy includingboth adult and pediatricpatients. It is intended toreplace film/screen systems inall general-purposediagnostic procedures. Thedevice is not intended formammography or dentalapplications.	Same
ClassificationName	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
ReadoutMechanism:	Thin Film Transistor	Same
Image Matrix Size:	$3500 \times 4300$ pixels	Same
Item	Predicate Device:Mars1417X Wireless DigitalFlat Panel Detector	Proposed Device:Focus HD 35 Detector
Pixel Size:	100μm	Same
ADC Digitization	16 bit	Same
EffectiveImagingArea:	350.0 mm × 430.0 mm	Same
Spatial Resolution:	Min. 4.3lp/mm	5.0 lp/mm
ModulationTransferFunction(MTF)	0.65 at 1 lp/mm	Same
DetectiveQuantumEfficiency(DQE)	0.54 at 1 lp/mm (RQA5,2.5μGy)	Same
PowerConsumption:	Max. 19W	Max.35.5W
Communications:(Wirelessfunctionality)	a) Wired (only forservice) : GigabitEthernet (1000BASE-T)b) Wireless: IEEE802.11a/b/g/n/ac (2.4GHz / 5 GHz)	Same
ImagingprotectPlate:	Carbon Fiber Plate	Same
Cooling:	Air cooling	Same
Dimensions:	384 mm × 460 mm × 15 mm	Same
Item	Predicate Device:Mars1417X Wireless DigitalFlat 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 overthe whole area of the surface;	Uniform load: 300 kg over thewhole area of the surface;
	Local load: 150 kg on anarea 4 cm diameter of center	Local load: 100 kg on an area 4cm 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 andTransportation:( 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) isintend to supply API interfacefor DR system manufacturers.DR system manufacturercontrol the detector by SDKinterface. SDK is not intendto use directly by other users	Same
Item	Predicate Device:	Proposed Device:
	Mars1417X Wireless DigitalFlat Panel Detectorbeside DR systemmanufacturers.	Focus HD 35 Detector
Utilized FDAguidancedocuments	1. Guidance for theSubmission of 510(k)'sfor Solid State X-rayImaging Devices;2. The 510(k) Program:Evaluating SubstantialEquivalence in PremarketNotifications[510(k)];3. Content of PremarketSubmissions forManagement ofCybersecurity in MedicalDevices;4. Radio FrequencyWireless Technology inMedical Devices;5. Guidance for “PremarketAssessment of PediatricMedical Devices”;6. Guidance for “PediatricInformation for X-rayImaging DevicePremarket Notifications”.	Same
Item	Predicate Device:Mars1417X Wireless DigitalFlat Panel Detector	Proposed Device:Focus HD 35 Detector
	7. The Special 510(k)Program8. Design Control GuidanceFor Medical DeviceManufacturers9. Appropriate Use ofVoluntary ConsensusStandards in PremarketSubmissions for 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 the distributor or manufacturer's service office.

1. 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.
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:
  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).

1. Clinical Consideration:
  Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with

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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.

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.