The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.

Device Description

The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Portable X-ray System (Canis014D07). It outlines the device's indications for use, its technological characteristics compared to predicate and reference devices, and a summary of non-clinical testing conducted to demonstrate safety and effectiveness.

However, the document does not contain information related to specific acceptance criteria for diagnostic performance, a study evaluating device performance against such criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Summary of Performance Testing" section states that the performance test for the device and predicate are "identical in the indications for use, patient population, intended operation environment, and electrical safety." It also mentions "Validation was performed for overall operation by taking and reviewing test images" and that "the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality." This suggests a qualitative assessment of image quality rather than a quantitative study with pre-defined diagnostic performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study that proves acceptance criteria are met, as this information is not present in the provided text.

Based on the available text, here's what can be extracted with respect to your request, noting the missing information:

Acceptance Criteria and Study Details (Based on Available Information)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
*Not specified for diagnostic performance.* The document focuses on compliance with electrical, mechanical, environmental safety, and radiation standards.	*Not specified for diagnostic performance.* The document states: ul>Images were reviewed by a professional with adequate qualifications.Images were of diagnostic quality.The device is "as safe, as effective, and performs as well as the primary predicate." (This is a comparative claim rather than a specific performance metric.)

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

Sample Size for Test Set: Not specified. The document mentions "test images were reviewed," but the number of images is not provided.
Data Provenance: Not specified.

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

Number of Experts: "a professional" (singular)
Qualifications of Experts: "a professional with adequate qualifications" (No specific details like "radiologist with 10 years of experience" are provided).

4. Adjudication method for the test set:

Adjudication Method: Not specified. It appears a single professional reviewed the images for diagnostic quality.

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:

MRMC Study: No, an MRMC study was not described. The device is an X-ray system, not an AI algorithm for image interpretation.

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

Standalone Performance: Not applicable. This device is an X-ray imaging system, not an AI algorithm. Its performance refers to its ability to produce diagnostic images, not to interpret them. The document explicitly states, "The images presented in the product screen are for preview purposes only, not for imaging diagnosis."

7. The type of ground truth used:

Type of Ground Truth: Expert opinion on "diagnostic quality" of the images produced by the device.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/not specified. The device is a hardware X-ray system, not an AI algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable.

Summary

{0}------------------------------------------------

January 17, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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. % Wei Pan Registration and Regulatory Affairs Director No.33 Xinggang Rd. Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K223010

Trade/Device Name: Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: December 19, 2022 Received: December 19, 2022

Dear Wei Pan:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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,

2023.01.17
Lu Jiang 21:51:54
-05'00'

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223010

Device Name Portable X-ray System

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)	□

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

iRay Imaging Technology (Haining) Limited

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

{4}------------------------------------------------

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

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

Sep. 18, 2022

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:	iRay Technology Taicang Ltd.
Company Address:	No.33 Xinggang Rd., Taicang Port Economic &Technological Development Zone
Contact Person:	Wei Pan
Phone:	+86 21 50720560
Fax:	+86 21 50720561
Email:	wei.pan@iraygroup.com

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

Trade Name:	Portable X-ray System
Common Name:	Extraoral Source X-ray System
Model Name:	Canis014D07
Classification Name:	Extraoral Source X-ray System
Product Code:	EHD
Regulation Number:	21 CFR 872.1800
Device Class:	Class II

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

The identification predicates within this submission are as follows:

Manufacturer:	GENORAY Co., Ltd.
Trade Name:	PORT-X IV
Model Name:	PORT-X IV
Product Code:	EHD
Classification Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Device Class:	Class II
FDA 510 (k) #:	K172810

{5}------------------------------------------------

The identification of reference device within this submission are as follows:

Manufacturer:	Aribex, Inc.
Trade Name:	NOMAD Pro X-ray system
Model Name:	NOMAD Pro
Product Code:	EHD
Classification Name:	Extraoral Source X-ray System
Regulation Number:	21 CFR 872.1800
Device Class:	Class II
FDA 510 (k) #:	K081664

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

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

6.1. Indications for use

The portable X-Ray system is used as a portable, extra oral x-ray source for

producing diagnostic x-ray images using conventional film, PSP

(phosphor plates) or digital sensors. It is intended for adult and pediatric patients.

This equipment is available only to trained and qualified dentist or dental technician.

6.2. Suitable patient

The Canis014D07 is intended for adult and pediatric patients.

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

Item	Predicate Device:	Reference Device:	Proposed Device:
	PORT-X IV	NOMAD Pro	Canis014D07
Model name	PORT-X IV	NOMAD Pro	Canis014D07
510(K) Number	K172810	K081664	K223010
ClassificationName	Extraoral Source X-raySystem	Same	Same
Product Code	EHD	Same	Same
Item	Predicate Device:	Reference Device:	Proposed Device:
	PORT-X IV	NOMAD Pro	Canis014D07
Regulation Number	21 CFR 872.1800	Same	Same
Panel	Dental	Same	Same
Classification:	II	Same	Same
Installation Type:	Portable	handheld	Portable
Indications for use	PORT-X IV is aportable X-ray systemto be used by traineddentists and dentaltechnicians as a mobile,extraoral x-ray sourcefor producingdiagnostic x-ray imagesusing intraoral imagereceptors. It is intendedfor both adult andpediatric subjects.	The NOMAD Pro X-ray System is intendedto be used by traineddentists and dentaltechnicians as anextraoral X-ray sourcefor producingdiagnostic X-rayimages using intraoralimage receptors. Its useis intended for bothadult and pediatricsubjects	The Portable X-raySystem is used as aportable, extra oral x-ray source forproducing diagnostic x-ray images usingconventional film, PSP(phosphor plates) ordigital sensors. It isintended for adult andpediatric patients.This equipment isavailable only totrained and qualifieddentist or dentaltechnician.
X-ray Monoblock	Tube Voltage : 70 kV	Tube Voltage : 60 kVfixed	Tube Voltage : 70 kV
	Tube Current : 2 mA	Tube Current : 2.5 mA	Tube Current : 2 mA
	Stationary Anode	Stationary Anode	Stationary Anode
	Focus : 0.4 mm	Focus : 0.4 mm	Focus : 0.4 mm
	Target Angle : 12.5°Total Filtration : 2.2	Target Angle : 12.5°Total Filtration :1.5mmAl	Target Angle : 12.5°Total Filtration : 3.1
	mmAl		mmAl
	(Inherent Filtration : 1.0mmAl;		(Inherent Filtration : 1.0mmAl;
	Additional Filtration :1.2 mmAl)		Additional Filtration :2.1 mmAl)
Exposure controller	Exposure Time :0.05~1.6 sec.	Exposure Time : 0.02~1sec.	Exposure Time : 0.04~2sec.
Battery	Rechargeable lithiumbattery	Same	Same
Display	LCD panel Dispaly	Same	Same
Dimensions	(140 × 173 × 254)mm	(280×165×296)mm	(197×139×240) mm
Weight	1.6 kg	2.5kg	2.2kg
Item	Predicate Device:PORT-X IV	Reference Device:NOMAD Pro	Proposed Device:Canis014D07
Cooling:	Air cooling	Same	Same
Protection againstmatter/Water	IPX0	Same	Same
Operation:	Temperature: 10 to 35°C	Temperature: -5 to 40°C	Temperature: 10 to 40°C
	Humidity: 30 to 85%(Non-Condensing)	Humidity: 10 to 80%(Non-Condensing)	Humidity: 10 to 90%(Non-Condensing)
	Atmospheric pressure:70 to 106 kPa	Atmospheric pressure:70 to 106 kPa	Atmospheric pressure:70 to 106 kPa
	Altitude: Max. 3000meters	Altitude: Max. 3000meters	Altitude: Max. 3000meters

Humidity: 10 to 90%(Non-Condensing)	Humidity: 95% (Non-Condensing)	Humidity: 5% ~ 95%(Non-Condensing)
Atmospheric pressure:50 ~ 106 kPa	Atmospheric pressure:	Atmospheric pressure:70kPa~106kPa
Altitude: Max. 3000meters	Altitude: Max. 3000meters	Altitude: Max. 3000meters
			Software

{6}------------------------------------------------

[510(k)] Application

{7}------------------------------------------------

[510(k)] Application

8. Safety, EMC and Performance data comparison to Predicate device

8.1 Safety, EMC and Performance data
Canis014D07 complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30 and 21CFR 1020.31 to minimize electrical, mechanical and radiation hazards.
Electrical, mechanical, environmental safety and performance testing which are a) mentioned in the standard ANSI ES:60601-1, IEC 60601-1-3 and IEC 60601-2-65 were performed.
EMC testing was conducted in accordance with standard IEC 60601-1-2. b)
Performance testing performed according to FDA 21 CFR 1020.30, 21 CFR c) 1020.31 standards, Software Validation, nonclinical Evaluation. All test

5 of 7

{8}------------------------------------------------

results were fulfill the requirements.

8.2 Summary of Performance Testing
The performance test for the subject device (Canis014D07) and the predicate device (PORT-X IV, K172810) are identical in the indications for use, patient population, intended operation environment, and electrical safety. They are similar in technical specification. The differences between the proposed device and the predicate device will not raise any new risk to affect safety or effectiveness.

9. Nonclinical study

9.1 Electrical Safety and EMC Summary
The electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:
ANSI AAMI ES60601-1:2005 + A1:2012 + A2:2021 a)
b) IEC 60601-1-3:2008 + A1:2013 + A2:2021
IEC 60601-2-65:2012 + A1:2017 C)
d) IEC 60601-1-2:2014

9.2 Bench Testing Summary

The verification test results showed compliance with the above standards. Validation was performed for overall operation by taking and reviewing test images. The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate.

9.3 Summary of Clinical Tests:
The subject of this premarket submission, the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality did not require more clinical studies.

10. FDA Guidance Documents Utilized

Format for Traditional and Abbreviated 510(k)s Guidance issued on September 13, a) 2019.
Radio Frequency Wireless Technology in Medical Devices b)
Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards c)

6 of 7

{9}------------------------------------------------

Guidance for the Content of Premakret Submissions for Software Contained d) in Medical Devices, issued Nov 28, 2017
e) Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
a) Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014

11. 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, the manufacturer, iRay Imaging Technology (Haining) Limited concludes that Canis014D07 is substantially equivalent to predicate device with regards to safety and effectiveness.

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.