The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.

Device Description

This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.

AI/ML Overview

This document is an FDA 510(k) summary for the Galaxy R Digital Radiography Upgrade, a device intended to replace radiographic film/screen systems in general-purpose diagnostic procedures (excluding mammography). The submission aims to demonstrate substantial equivalence to the predicate device, Atlaim ATAL 8C (K113812).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined in terms of specific performance thresholds that the device must meet in a formal, quantifiable sense within this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved through a comparison table highlighting technological characteristics. The "performance" is implicitly compared to the predicate, with minor differences deemed not to have a material effect on safety or effectiveness.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Galaxy R Digital Radiography Upgrade)	Conclusion (Relative to Predicate)
Indications for Use	For generating radiographic images of human anatomy, to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications. (ATAL 8C)	For generating radiographic images of human anatomy, to replace a radiographic film/screen system in all general-purpose diagnostic procedures. Not for mammography.	SAME
Panel Communication	Tethered Gigabit Ethernet, one panel (ATAL 8C)	SAME	SAME
Sensor Type	a-Si TFT array Panel detector (ATAL 8C)	a-Si TFT array Panel detector	SAME
Scintillator	CSI & GOS (ATAL 8C)	CSI & GOS	SAME
Panel Resolution	3072 x 3072 pixels, 3.1 lp/mm (ATAL 8C)	3,072 x 3,072 pixels, 3.7 lp/mm. Also available in 3072x2560 pixels (14 x 17 size).	SAME (with additional size option)
Panel Size	17" X 17" (ATAL 8C)	17" X 17" SAME or available in 14" x 17"	SAME (with additional size option)
Weight	3.8kg (ATAL 8C)	3.3 kg or 2.9kg (14 x 17)	NOT A MEANINGFUL DIFFERENCE
Pixel Size	139 μm (ATAL 8C)	140 μm	NOT A MEANINGFUL DIFFERENCE
Image Depth	16 bits (ATAL 8C)	16 bits	SAME
Preview Image	2-5 seconds (ATAL 8C)	Less than 3 seconds	EQUIVALENT
DICOM	Yes (ATAL 8C)	SAME	SAME
Safety/EMC	EN/IEC 60601-1, Safety; EN/IEC 60601-1-2 EMC (ATAL 8C)	SAME, plus tested to IEC 60601-1-6, Medical electrical equipment, Part 1-6: General requirements for safety - Collateral Standard: Usability, including IEC 62366: Application of usability engineering to medical devices.	SAME (with additional testing for usability)
Operating Environment	10°-35°C, 20%-75% RH (non-condensing) (ATAL 8C)	Sensor unit: 10-35°C, 40-80% RH (non-condensing)	EQUIVALENT
MTF @2 lp/mm	28% CSI, 22% GOS (ATAL 8C)	25% CSI, 20% GOS	Slightly lower than predicate, but implied as a non-meaningful difference.
Trigger	Auto sense or manual (ATAL 8C)	SAME	SAME
Power Source	100-250V ~ 50/60Hz 250V ~ (ATAL 8C)	100-250V ~ 50/60Hz 250V	SAME

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

Sample Size (Test Set): Not explicitly stated with a specific number of images. The document states "Clinical images of actual patients were submitted."
Data Provenance: Not explicitly stated (e.g., country of origin). The images were from "actual patients," implying retrospective or prospective clinical acquisition, but the specific study design for the clinical images is not detailed.

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

Number of Experts: Singular, "Board Certified Radiologist."
Qualifications of Experts: "Board Certified Radiologist." No specific experience in years is mentioned.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the clinical images "were evaluated by Board Certified Radiologist and found to be of excellent diagnostic quality." This implies a single expert review for quality, not a consensus-based adjudication for ground truth for diagnostic accuracy.

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. The device is an upgrade to a digital radiography system, not an AI-assisted diagnostic tool.

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

Yes, in a sense. The "non-clinical tests" section describes bench testing for imaging characteristics like MTF and DQE, which are measurements of the device's technical performance independent of human interpretation. The "clinical images" were used to show the complete system works as intended, evaluated by a radiologist. This suggests standalone performance of the image acquisition hardware, with a human validating the output quality.

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

For the non-clinical tests (MTF, DQE), the "ground truth" is derived from physical measurements and technical standards in accordance with the FDA Guidance Document on Solid State Imaging Devices.

For the clinical images, the ground truth is expert opinion/evaluation by a single Board Certified Radiologist, who deemed them to be "of excellent diagnostic quality." This is a qualitative assessment of image quality for diagnostic purposes, not a definitive ground truth for specific pathologies or outcomes.

8. The Sample Size for the Training Set

The document does not mention any training set. This device is a digital radiography upgrade, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as no training set is mentioned for this type of device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2017

MEDIEN INTERNATIONAL Co., Ltd. % Daniel Kamm, PE Kamm and Associates 8870 Ravello Ct. NAPLES FL 34114

Re: K172435

Trade/Device Name: Galaxy R Digital Radiography Upgrade Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 07, 2017 Received: August 11, 2017

Dear Mr. Kamm:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Daniel Kamm, P.E.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara For

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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Indications for Use

510(k) Number (if known) K172435

Device Name Galaxy R Digital Radiography Upgrade

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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510(k) Summary K172435

1. Submitter: Name - MEDIEN INTERNATIONAL Co., Ltd. Address – Medien Office Tower, 50, Heungan-daero 427 Beon-gil Dongan-gu Anyang-si, KOREA, REPUBLIC OF 435-040 Tel - +82-31-451-9466 Fax - +82-31-451-9468 Contact – Jaehyun Lee, jhlee@medien.co.kr Date prepared: October 3, 2017
1. Identification of the Device: Galaxy R Digital Radiography Upgrade Classification Name: Stationary x-ray system Product Code: MQB Common/Usual Name: Stationary x-ray system (digital) Device Class/Regulation Number: Class II per 21 CFR 892.1680
1. Predicate Device: Manufacturer: Atlaim Device: Atal 8C Number: K113812 Classification Name: Stationary x-ray system Product Code: MQB Common/Usual Name: Stationary x-ray system (digital) Device Class/Regulation Number: Class II per 21 CFR 892.1680
1. A description of the device: This device is medical image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a personal computer (via Ethernet) where the companion software has been installed. This software was cleared in our previous submission, K132921, and it has not been modified. A monitor displays this image. Images can then be transferred via the DICOM protocol. There are four models available, two are 14″ x 17″ and two are 17″ x 17″ (Available in either CSI or GOS scintillator versions). The user must supply the x-ray generator and tubestand to form a full system. Exposure can be Generator Synchronous, or via - AED (Auto Exposure Detection). The technology is Amorphous Silicon (a-Si) Photodiode coupled with either the Gadox or Cesium Iodide scintillators, same as in the predicate.
ഗ് Intended use of the device: The Galaxy R Digital Radiography Upgrade is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in all general purpose diagnostic procedures. Not for mammography.
1. The Galaxy R Digital Radiography Upgrade has essentially the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. See the comparison table below.

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	Comparison Table
Characteristic	Atlaim ATAL 8C, K113812	Galaxy R Digital Radiography Upgrade
Indications	The ATAL 8 and ATAL 8C are indicated foruse in general radiographic Intended use:images of human anatomy. It is intendedto replace radiographic film/screensystems in all general-purpose diagnosticprocedures, excluding fluoroscopic,angiographic, and mammographicapplications	The Galaxy R Digital Radiography Upgradeis indicated for use in generatingradiographic images of human anatomy. Itis intended to replace a radiographicfilm/screen system in all general purposediagnostic procedures. Not formammography. (SAME)
Panel Communi-cation	Tethered Gigabit Ethernet, one panel	SAME
Sensor Type	a-Si TFT array Panel detector	a-Si TFT array Panel detector SAME
Scintillator	CSI & GOS	CSI & GOS SAME
Panel Resolution	3072 x 3072 pixels3.1 lp/mm.	3,072 x 3,072 pixels3.7lp/mm. SAME.Also available in 3072x2560 pixels (14 x 17size)
Panel Size	17 X 17	17 X 17 SAME or available in 14 x 17
Weight	3.8kg	3.3 kg or 2.9kg (14 x 17) NOT AMEANINGFUL DIFFERENCE
Pixel Size	139 μm	140 μm. NOT A MEANINGFUL DIFFERENCE
Image depth	16 bits	16 bits SAME
Preview Image	2-5 seconds	Less than 3 seconds EQUIVALENT
DICOM	Yes	SAME
Safety/EMC	EN/IEC 60601-1, SafetyEN/IEC 60601-1-2 EMC	SAME, plus tested to IEC 60601-1-6,Medical electrical equipment, Part 1-6:General requirements for safety- CollateralStandard: Usability, including IEC 62366:Application of usability engineering tomedical devices
OperatingEnvironment	10°-35°C, 20%-75% RH (non-condensing)	Sensor unit: 10-35°C, 40-80% RH(non-condensing) EQUIVALENT
MTF @2 lp/mm	28% CSI, 22% GOS	25% CSI, 20% GOS
Trigger	Auto sense or manual	SAME
Power Source	100-250V ~ 50/60Hz 250V ~	100-250V ~ 50/60Hz 250V SAME
Characteristic	Atlaim ATAL 8C, K113812	Galaxy R Digital Radiography Upgrade
Photo	Image: Atlaim ATAL 8C, K113812	Image: Galaxy R Digital Radiography Upgrade

Comnarison Tahle

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Comparison Conclusion:

The proposed new device has these similarities:

Similarity of Intended for use, Similarity of Sensor Type, Similarity of Active Area, Similarity of Sensor Pixel, Similarity of Pixel Size, Similarity of Dimensions, and Similarity of Performance characteristics. The minor differences do not have a material effect on safety or effectiveness, and are therefore substantially equivalent.

1. Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as software validation and risk analysis. Bench testing for imaging characteristics such as MTF and DQE was performed in accordance with the FDA Guidance Document on Solid State Imaging Devices. Labeling complies with FDA guidelines. Testing was performed in accordance with the following standards: (1) IEC 60601-1, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (2) EN/IEC 60601-1-2:2007, Medical electrical equipment Electromagnetic Compatibility (3) NEMA PS 3.1~PS 3.18 Digital Imaging and Communications in Medicine (DICOM)] (4) IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
1. Description of clinical tests. Clinical images of actual patients were submitted; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray digital detector based on imaging technology identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. They were evaluated by Board Certified Radiologist and found to be of excellent diagnostic quality.
1. Conclusions drawn: The nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.

Regulation Number and Section

N/A