(26 days)
Not Found
No
The summary describes a standard digital X-ray system and its components, focusing on image acquisition and processing without mentioning any AI or ML capabilities.
No
This device is an imaging system designed to generate radiographic images for diagnosis, not to treat a condition.
Yes
The device is used to generate radiographic images for reading, which allows a qualified/trained doctor or technician to analyze and diagnose conditions of human anatomy.
No
The device description explicitly lists multiple hardware components (High voltage generator, Tube Stand, Wall Bucky Stand, Patient table, Detector, X-ray tube, Collimator, AEC, DAP, CIB, Grid, Barcode scanner) that are integral to its function as a digital X-ray imaging system. While it includes operation software, it is not solely software.
Based on the provided information, the GF50A Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to generate radiographic images of human anatomy. This involves imaging the internal structures of the body using X-rays.
- Device Description: The device components are all related to generating and capturing X-ray images of a patient.
- Mechanism: The system works by transmitting X-rays through a patient's body and capturing the resulting image.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The GF50A system operates in vivo (within the living body) by using external radiation to create images, rather than analyzing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Product codes
KPR
Device Description
The GF50A digital X-ray imaging system consists of High voltage generator (HVG), Tube Stand, Wall Bucky Stand, Patient table, Detector, X-ray tube, Collimator, Automatic Exposure Control(AEC), Dose Area Product(DAP), Control Interface Box (CIB), Grid and Barcode scanner.
This system is used to capture images by transmitting X-ray to a patient's body.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
Mentions image processing
Yes
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
qualified/trained doctor or technician
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 data: the proposed detector shows curves and measurements of MTF and DQE that do not differ from the predicate device, and the proposed GF50A has been shown a substantially equivalent to the predicate device.
Clinical data: Not required since the difference of Max Power, Tube Voltage and Current of HVG does not affect the clinical images of the detector which was cleared with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MTF, DQE
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & 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 profiles facing right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
SAMSUNG ELECTRONICS Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro. Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA
Re: K151419
Trade/Device Name: GF50A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 27, 2015 Received: May 28, 2015
Dear Chulsin Kim:
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 device-related 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
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/Resourcesfor You/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,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GF50A
Indications for Use (Describe)
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
| 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."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upwards from left to right.
510(k) Premarket Notification - Traditional
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: May 27, 2015
-
- Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
3. Primary Contact Person
- A. Name: KIM, CHULSIN
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-7661
- FAX Number: +82-31-200-1199 D. E-Mail: chulsin.kim@samsung.com
4. Secondary Contact Person
- Name: Ninad Gujar A.
- B. Title: Regulatory Affairs Manager
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-750-6677 E-Mail: ngujar@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GF50A
- B. Device Name: GF50A
- Common Name: Digital Diagnostic X-ray System C.
- Classification Name: Stationary X-ray System D.
- ட். Product Code: KPR
- F. Regulation: 21 CFR 892.1680
6. Predicate Device
- A. Manufacturer: SAMSUNG ELECTRONICS Co., Ltd.
- B. Device Name: XGEO GF50
- C. Common Name: Digital Diagnostic X-ray System
- Classification Name: Stationary X-ray System D.
- E. Product Code: KPR
- F. Regulation: 21 CFR 892.1680
- 510(k) Number: K140326 G.
- 510(k) Decision Date: May 28, 2014 H.
4
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.
510(k) Premarket Notification - Traditional
7. Device Description
The GF50A digital X-ray imaging system consists of High voltage generator (HVG), Tube Stand, Wall Bucky Stand, Patient table, Detector, X-ray tube, Collimator, Automatic Exposure Control(AEC), Dose Area Product(DAP), Control Interface Box (CIB), Grid and Barcode scanner.
This system is used to capture images by transmitting X-ray to a patient's body.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
8. Intended Use
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed GF50A has a High voltage generator different from the one the predicate device has, which does not have significant change in materials, energy source or technological characteristics compared to the predicate device, XGEO GF50 (K140326).
Comparisons with technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.
| Manufacturer Contents | XGEO GF50 (K140326) | GF50A | Discussion | |
|---|---|---|---|---|
| (1)High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 52kW | 40kW | Differences(1) | |
| Output | ||||
| RANGE | Tube Voltage | 40-150kV | 40-125kV | Differences(2) |
| Tube Current | 10-640mA | 10-500mA | Differences(3) | |
| Exposure Time | 1msec-10sec | 1msec-10sec | Same |
| A. Differences Explanation | ||||
|---|---|---|---|---|
| ---------------------------- | -- | -- | -- | -- |
| No. | Differences | Explanation |
|---|---|---|
| (1) | HVG Max Power | Proposed medical device's HVG has lower max power than the predicate device's max power, and the lower max power does not contribute any adverse impacts to the device's safety and performance. |
| (2) | Tube Voltage | Proposed medical device's HVG has lower Tube voltage than the predicate device's Tube voltage, and the lower Tube voltage does not contribute any adverse impacts to the device's safety and performance. |
| (3) | Tube Current | Proposed medical device's HVG has lower Tube current than the predicate device's Tube current, and the lower Tube current does not |
5
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font, set against a blue, rounded-rectangle background. The logo is simple and modern, and it is easily recognizable.
510(k) Premarket Notification - Traditional
contribute any adverse impacts to the device's safety and performance.
In non-clinical data, the proposed detector shows curves and measurements of MTF and DQE that do not differ from the predicate device, and the proposed GF50A has been shown a substantially equivalent to the predicate device.
10. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
11. Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
12. Clinical data
Not required since the difference of Max Power, Tube Voltage and Current of HVG does not affect the clinical images of the detector which was cleared with the predicate device.
13. Conclusions
The results of the non-clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed device identified in paragraph 6.