(63 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard digital radiography technology and image acquisition/transfer.
No.
The device is indicated for generating radiographic images for diagnostic procedures, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace a radiographic film/screen system in all general purpose diagnostic procedures." The "Summary of Performance Studies" also mentions that images were evaluated by a "Board Certified Radiologist and found to be of excellent diagnostic quality."
No
The device description explicitly states it includes a detector (hardware) that converts X-rays to a digital file, which is then sent to a computer. The submission also includes non-clinical tests for electrical safety, electromagnetic compatibility, and bench testing for imaging characteristics (MTF and DQE), all of which relate to hardware performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Galaxy R Digital Radiography Upgrade is an image acquisition device that uses X-rays to create images of the inside of the human body. This is an in vivo process, not an in vitro one.
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy," which aligns with diagnostic imaging, not in vitro testing.
Therefore, the device described is a medical imaging device, specifically a digital radiography system component, and not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing health and well-being.
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.
1
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
2
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)
| ☑ 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
-
- 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
-
- 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
-
- 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
-
- 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.
-
- 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 | |
| use in general radiographic Intended use: | ||
| images of human anatomy. It is intended | ||
| to replace radiographic film/screen | ||
| systems in all general-purpose diagnostic | ||
| procedures, excluding fluoroscopic, | ||
| angiographic, and mammographic | ||
| applications | 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. (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 pixels | |
| 3.1 lp/mm. | 3,072 x 3,072 pixels | |
| 3.7lp/mm. SAME. | ||
| Also available in 3072x2560 pixels (14 x 17 | ||
| 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 |
| 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 | |
| EN/IEC 60601-1-2 EMC | 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 | ||
| Operating | ||
| Environment | 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
5
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.
-
- 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
-
- 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.
-
- 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.