Galaxy R Digital Radiography Upgrade

K172435 · Medien International Co, Ltd. · MQB · Oct 13, 2017 · Radiology

Device Facts

• Record ID: K172435
• Device Name: Galaxy R Digital Radiography Upgrade
• Applicant: Medien International Co, Ltd.
• Product Code: MQB · Radiology
• Decision Date: Oct 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

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 Story

Galaxy R Digital Radiography Upgrade is a medical image acquisition device designed to replace film/screen systems. It consists of an amorphous silicon (a-Si) TFT panel detector with either Gadox or Cesium Iodide scintillators. The device captures X-rays penetrating a patient's body, converts them into digital files, and transmits them via Ethernet to a PC running companion software. The system supports both generator-synchronous and Auto Exposure Detection (AED) triggering. It is intended for use in clinical settings where a user-supplied X-ray generator and tubestand are present. The software displays images on a monitor and facilitates transfer via DICOM protocol. By digitizing radiographic imaging, the device enables efficient image storage, retrieval, and transmission, potentially improving diagnostic workflows and patient care compared to traditional film-based systems.

Clinical Evidence

Clinical images of actual patients were submitted to supplement laboratory performance data. These images were evaluated by a Board Certified Radiologist and deemed to be of excellent diagnostic quality, confirming the system functions as intended.

Technological Characteristics

Amorphous Silicon (a-Si) TFT panel detector; Gadox or Cesium Iodide scintillators; 16-bit image depth; Gigabit Ethernet connectivity; DICOM compliant. Standards: IEC 60601-1 (Safety), EN/IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 62366 (Usability Engineering), NEMA PS 3.1-3.18 (DICOM).

Indications for Use

Indicated for generating radiographic images of human anatomy in general purpose diagnostic procedures. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Atal 8C (K113812)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 - [phone] Fax - [phone] Contact – Jaehyun Lee, [e-mail] Date prepared: October 3, 2017
- 2. 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
- 3. 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
- 4. 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.
- 6. 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 for<br>use in general radiographic Intended use:<br>images of human anatomy. It is intended<br>to replace radiographic film/screen<br>systems in all general-purpose diagnostic<br>procedures, excluding fluoroscopic,<br>angiographic, and mammographic<br>applications | The Galaxy R Digital Radiography Upgrade<br>is indicated for use in generating<br>radiographic images of human anatomy. It<br>is intended to replace a radiographic<br>film/screen system in all general purpose<br>diagnostic procedures. Not for<br>mammography. (SAME) |
| Panel Communi-<br>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 pixels<br>3.1 lp/mm. | 3,072 x 3,072 pixels<br>3.7lp/mm. SAME.<br>Also available in 3072x2560 pixels (14 x 17<br>size) |
| 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 A<br>MEANINGFUL 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, Safety<br>EN/IEC 60601-1-2 EMC | SAME, plus tested to IEC 60601-1-6,<br>Medical electrical equipment, Part 1-6:<br>General requirements for safety- Collateral<br>Standard: Usability, including IEC 62366:<br>Application of usability engineering to<br>medical devices |
| Operating<br>Environment | 10°-35°C, 20%-75% RH (non-condensing) | Sensor unit: 10-35°C, 40-80% RH(non-<br>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.

- 7. 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
- 8. 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.
- 9. 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.