The device is a diagnostic x-ray system, which 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 intra-oral image receptors. its use is intended for both adults and pediatric subjects.

Device Description

The portable x-ray system (Models: MiniX-V, MiniX-S) is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on fixable stands as optional arms in user manual or digital camera tripods. Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor. Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.

AI/ML Overview

The provided FDA 510(k) summary for the DIGIMED Portable X-ray System (Models: MiniX-V, MiniX-S) states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." and therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria is described.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DIGIMED Portable X-Ray System, K152859) primarily through technical specifications and compliance with safety and performance standards. The only difference noted between the new device and the predicate is the "X-ray waveform" (mixed pulse versus constant potential (DC)).

However, based on the information provided, here's a breakdown of what can be inferred about the safety and performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance acceptance criteria are not mentioned as necessary for substantial equivalence, the "acceptance criteria" presented below are for technical and safety aspects, which are implied to be met for FDA clearance.

Acceptance Criteria Category	Specific Criteria (Inferred from documentation)	Reported Device Performance
Output X-ray Parameters
kVp (MiniX-V)	Max 70kV	Max 70kV (Model MiniX-V)
kVp (MiniX-S)	Max 60kV	Max 60kV (Model MiniX-S)
mA	2 mA fixed	2 mA fixed
Exposure time	0.01~2.0 seconds in 0.01 increments	0.01~2.0 seconds in 0.01 increments
Time Accuracy	$\pm$ (10% + 1 ms)	$\pm$ (10% + 1 ms)
Half-value layer (MiniX-V)	2.3 mm Al	2.3 mm Al
Half-value layer (MiniX-S)	2.0 mm Al	2.0 mm Al
Safety Standards
EMI standards	EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3	Complies
Performance standards	IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304	Complies (Performance evaluation reports provided)
Radiation Safety	Compliance with "Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use"	Assumed to comply as per FDA's review and clearance
Cybersecurity	Compliance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"	Assumed to comply as per FDA's review and clearance
General User Safety	All units completely shielded by lead or high-density materials to protect from unnecessary radiation	Device description states this
Mechanical/Physical
Size	4.8" x 8.7" x 5.3"	4.8" x 8.7" x 5.3"
Source to skin distance	20 cm	20 cm
Cone diameter	5.3 cm	5.3 cm
Backscatter protection	6.3" dia. Pb-filled acrylic plastic scatter shield	6.3" dia. Pb-filled acrylic plastic scatter shield
Duty Cycle	1:60	1:60

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

The document does not describe a clinical "test set" in the sense of patient data used for diagnostic performance evaluation. The "test reports" mentioned are for compliance with technical, electrical, and safety standards (e.g., IEC standards, EMI standards). These typically involve laboratory testing of the device itself, not human subjects. Therefore, no sample size for a clinical test set or data provenance is provided.

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

As no clinical test set is described, this information is not applicable and therefore not provided.

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

As no clinical test set is described, this information is not applicable and therefore not provided.

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 was mentioned or performed. This submission is for an X-ray imaging device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This implies that the review was focused on the device's technical specifications and safety profile, not its diagnostic efficacy compared to a predicate or with AI assistance.

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

No standalone algorithm performance study was mentioned or performed, as this is a hardware device (X-ray system), not a software algorithm or AI.

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

Since the primary evaluation was for technical/safety compliance and substantial equivalence to a predicate device, the "ground truth" would be established by validated testing equipment and adherence to recognized international standards (e.g., IEC, CISPR) and FDA guidance documents. For example, an oscillometer would measure the kVp output, and its reading would be the ground truth for that specification.

8. The sample size for the training set

Not applicable. This device is a portable X-ray system, not an AI model requiring a training set of images.

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

Not applicable. This device is a portable X-ray system, not an AI model requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows 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 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.

August 10, 2018

DIGIMED Co., Ltd. % Mr. Yong Park President INNODEN LLC 212 Wells Ave.S #102 RENTON WA 98057

Re: K181891

Trade/Device Name: Portable X-rav System (Models: MiniX-V. MiniX-S) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 13, 2018 Received: July 13, 2018

Dear Mr. Park:

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); and Part 809; medical

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device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hsl 2. Nils

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181891

Device Name Portable x-ray system (Model: MiniX-V, MiniX-S)

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.

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510(k) Summary of Portable X-ray System (MiniX-V & MiniX-S)

Date Prepared: Mar. 12, 2018 Company Name: DIGIMED CO., LTD. 309~311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Address: Seoul, 08506 Rep. of Korea Telephone number: +82-2-2624-1551 Fax: +82-2-2624-1553 E-mail: digimed@digimed.co.kr Contact: Youngbae Kwon, CEO

1. Company and Correspondent Making the Submission:

2. US Agent for FDA Contact:

Name	Mr. Yong Park
Company Name:	INNODEN LLC.
Address:	212 Wells Ave. S #102,Renton, WA 98057
Telephone number:	425-572-0283
Fax:	425-988-1256
E-mail:	drpark@innoden.com

3. Device Information:

Proprietary-Trade Name:	Portable X-Ray System (Models: MiniX-V, MiniX-S)
Classification Name:	Extra-oral Source X-Ray System: EHD, Class II perregulation 21CFR 872.1800
Common/Usual Name:	Portable X-Ray System

4. Predicate Devices:

Manufacturer:	DIGIMED CO., LTD.
Device:	Portable X-Ray System(Model: MiniX-V, MiniX-S)
Classification:	Extra-oral Source X-Ray System: EHD, Class II perregulation 21CFR 872.1800
510(k) Number:	K152859

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5. Indications for Use (Intended Use):

The portable x-ray system (Models: MiniX-V, MiniX-S) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects.

Compatible intra-oral image receptors are described as below.

1. Analog dental x-ray films
1. CCD and CMOS digital sensors
1. Digital phosphor plates
1. Most of the intra-oral image receptors which intended for dental x-ray examination

6. Description of Device

The portable x-ray system (Models: MiniX-V, MiniX-S) is an x-ray generating device which is mainly designed for dental examination.

The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone).

The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation.

The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on fixable stands as optional arms in user manual or digital camera tripods.

Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor.

Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.

Detailed information of the device is described in "13. Device Description" of this submission.

7. Safety and Effectiveness, Comparison to Predicate Device:

Safety and effectiveness of the subject device is considered with the latest version of test regulations. The subject device was shown to provide an equivalent level of safety and performance as compared to the predicate devices.

"Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices"

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8. Safety, EMC and Performance Data:

The subject device complies with the safety and performance standards listed in the chart below. Test reports were provided to demonstrate conformance. All required documents and reports are submitted to the appropriate oversight agency to establish compliance with the applicable requirements.

9. The differences between the subject device and the predicate devices

The subject device has little differences with its design, size, and user interface compare to the predicate devices. Detailed differences can be identified from "Substantial Equivalence Chart".

10. FDA Guidance Documents utilized;

1. Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued December 24, 2008
1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
1. Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28, 2017
1. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014

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11. Substantial Equivalence Chart

FEATURE	DIGIMEDMiniX-V, MiniX-S(K152859)	DIGIMEDMiniX-V, MiniX-S(K181891)
INTENDED USE	All three systems are intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
MECHANICAL
Size	4.8" x 8.7" x 5.3"	4.8" x 8.7" x 5.3"
Source toskin distance	20 cm	20 cm
Cone diameter	5.3 cm	5.3 cm
User interface	Up-down buttons for exposure timeselection with timer display.Additionally, several user-selectablepreset times with patient size, image-receptor type, and tooth selection iconson an LCD display	Up-down buttons for exposure timeselection with timer display.Additionally, several user-selectablepreset times with patient size, image-receptor type, and tooth selection iconson an LCD display
Backscatterradiation protection	6.3" dia. Pb-filled acrylic plastic scattershield	6.3" dia. Pb-filled acrylic plastic scattershield
Exposure switch	Exposure button at front cover on righthand side,or a remote control switch	Exposure button at front cover on righthand side,or a remote control switch
Tubehead mounting	Handheld, on optional arms or on atripod	Handheld, on optional arms or on atripod
Half-value layer	MiniX-V: 2.3 mm AlMiniX-S: 2.0 mm Al	MiniX-V: 2.3 mm AlMiniX-S: 2.0 mm Al
ELECTRICAL
Energy source	Rechargeable 22.2 V DC LithiumPolymer battery pack	Rechargeable 22.2 V DC LithiumPolymer battery pack
Exposure time	0.01~2.0 seconds in 0.01 increments	0.01~2.0 seconds in 0.01 increments
Time Accuracy	$\pm$ (10% +1 ms)	$\pm$ (10% +1 ms)
mA	2 mA fixed	2 mA fixed
kVp	MiniX-V: 70kVMiniX-S: 60kV	70 kV max
Waveform	Constant Potential (DC)	Mixed pulse
Duty Cycle	1:60	1:60
EMI standards	EN60601-1-2, IEC60601-1-2CISPR 11, IEC61000-3-2IEC61000-3-3	EN60601-1-2, IEC60601-1-2CISPR 11, IEC61000-3-2IEC61000-3-3
X-RAY PERFORMANCE
Performancestandards	IEC 60601-1IEC 60601-1-3IEC 60601-2-65	IEC 60601-1IEC 60601-1-3IEC 60601-1-6IEC 60601-2-65IEC 62304
Difference	X-ray waveform

1. Predicate device (Model: MiniX-V, MiniX-S) from DIGIMED

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12. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the new 510k submission of the portable xray system (Models: MiniX-V, MiniX-S) has difference with its x-ray waveform compare to previous submission (K152829). Except the waveform, the system has the same specification as the previous submission.

Performance evaluation (test) reports and device inspection report confirmed that the Portable X-ray System is suitable for its intended use and user instruction of the device.

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.