(261 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard X-ray system components and performance testing.
No
The device is described as an "X-ray Imaging System" intended for "generating radiographic images" and taking/storing images for "diagnosis of patients." It is not described as providing any therapeutic benefit or treatment.
Yes
Explanation: The "Device Description" explicitly states that the system is "to be used to take and store image for diagnosis of patients."
No
The device description explicitly lists hardware components such as a High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, and Collimator, indicating it is a physical X-ray imaging system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or treatment.
- Device Function: The description clearly states the device is an "X-ray Imaging System" used for "generating radiographic images of human anatomy." This involves using radiation to create images of internal structures within the body, not analyzing samples taken from the body.
- Intended Use: The intended use is for "generating radiographic images of human anatomy," which aligns with imaging devices, not IVDs.
Therefore, the XGEO GU60A Digital X-ray Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The XGEO GU60A 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 XGEO GU60A digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.
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
Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (issued August 6, 1999). All test results were satisfied.
Key Metrics
Not Found
Predicate Device(s)
Revolution XR/d of General Electric Company
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/0 description: The image shows the text "SAMSUNG ELECTRONICS Co., Ltd." The text is in a sans-serif font and is black. The text is arranged on a single line and is centered in the image. The letters are evenly spaced and the text is easy to read.
510(k) Premarket Notification - Traditional
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: June 6, 2013
-
- 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: Charlie Mack
- B. Title: President of International Regulatory Consultants
- C. Phone Number: 541-376-5063
- D. FAX Number: 541-376-5063
- E. E-Mail: charliemack@irc-us.com
4. Secondary Contact Person
- A. Name: Shim, Kyungam
- Title: Regulatory Affairs Manager B.
- C. Phone Number: +82-31-200-3356
- FAX Number: +82-31-200-0700 D.
- E-Mail: kyungam.shim@samsung.com ய்
5. Device
- A. Trade Name: XGEO GU60A
- Common Name: Digital Diagnostic X-ray System B.
- ். Regulation: 21 CFR 892.1680
- D. Classification Name: System, X-ray, Stationary
- E. Product Code: KPR
6. Device Description
The XGEO GU60A digital X-ray imaging system is to be used to take and store image for
JUN 2 0 2013
1
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/1/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a black background. The word is written in a bold, sans-serif font. The black background is in the shape of an oval, with the word "SAMSUNG" centered inside. The image is a logo for the Samsung company.
510(k) Premarket Notification - Traditional
diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.
7. Intended Use
The XGEO GU60A 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.
8. Comparison with predicate device :
Samsung Electronics Co., Ltd., believes that the XGEO GU60A is substantially equivalent to the Revolution XR/d of General Electric Company.
Comparison with the predicate device made through the system component items such as detector, generator etc., has been proven to be similar in many ways, but differences in the seven items were found. Specifically, even if the differences of the capacity and size of High Voltage Generator, Ceiling Suspension, Wall stand and Patient table exists, these are considered minor impact on the safety and performance. Also, Collimator, Detector, and Image Process Function in terms of the design and the technology characteristic have differences in the following characteristics:
-
Configuration : PD and the proposed device have different configurations. PD is a ceiling type and the proposed device is a U-arm type. But it has no effect on safety.
-
Auto Positioning : The proposed device provides the auto positioning function. But it has no effect on safety.
-
High Voltage Generator : The specifications of high voltage generators are different. But it has no effect on safety. The proposed device has the lower output rating and wider time range which makes the mAs range of both devices similar.
-
Blade moving method: Motorized method for adjusting a collimator radiation field is only available. It just concerns on the method for control a radiation field and has not effect on safety.
-
Number of pixels : Number of pixels is different. A detector with a large number of pixels can cover a wider area of body. It has no effect on safety.
-
Pixel pitch : Pixel pitch, a measurement that indicates the distance between pixels and determines an image resolution, is different. It affects the image quality but it has
2
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
not effect on safety.
-
High contrast limiting resolution : High contrast limiting resolution is different due to the difference of the pixel pitch. The resolution is higher as the value of the pixel pitch is lower. It affects the image quality but it has no effect on safety.
-
DQE : The value of DQE is different. The detector type with CSI phosphor has higher DQE value. It affects the image quality but it has no effect on safety.
-
MTF : The value of MTF is different. The detector type with CSI phosphor has higher MTF value. It affects the image quality but it has no effect on safety.
-
Robust FPD : PD and proposed device have "Flat Panel Detector". And detector in proposed device has been passed reliability test (include drop test) so it is named "Robust FPD".
-
Adaptive Local Contrast Stretching : PD and proposed device have "Contrast enhancement image processing algorithm". And "Algorithm" in proposed device name is "ALCOS"
-
Remote Access : PD and proposed device have "Remote Access" function for Remote management system
-
Collision Avoidance System : PD and the proposed device have a function that prevents collisions with foreign objects, but detection sensors are different.
-
Micro Processor Controlled High Frequency Switching : PD and the proposed device have HVGs that include a microprocessor-based control system. Also, the control system uses a high frequency switching method to provide the required voltage and current outputs.
-
Full-Auto (Adaptive) mA Calibration : PD and the proposed device have the auto mA calibration function that can compensate for effects like filament aging. "Adaptive mA Calibration" is also used for the same function.
However, these differences do not have an effect on safety and effectiveness compared with the predicate device, Revolution XR/d of General Electric Company.
In summary, the XGEO GU60A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
In conclusion, the XGEO GU60A is substantially equivalent to Revolution XR/d of General Electric Company.
3
3
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/3/Picture/9 description: The image shows the Samsung logo. The logo is an oval shape with the word "SAMSUNG" written in white letters inside the oval. The oval is black. The logo is tilted slightly to the right.
510(k) Premarket Notification - Traditional
9. Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-54, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). And Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (issued August 6, 1999). All test results were satisfied.
10. Conclusions :
ﺮ
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Samsung Electronics Co., Ltd. concludes that The XGEO GU60A is safe and effective and substantially equivalent to predicate devices as described herein.
-
- Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three parallel lines that curve upwards and to the right, resembling a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
SAMSUNG ELECTRONICS Co., Ltd. % Mr. Charlie Mack Principle Engineer International Regulatory Consultants (IRC) 77325 JOYCE WAY ECHO OR 97826
Re: K123106
Trade/Device Name: XGEO GU60A Digital Diagnostic X-ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 21, 2013 Received: May 29, 2013
Dear Mr. Mack:
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 andadulteration. 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.
5
Page 2 - Mr. Mack
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Sm.h.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K123106
Device Name: Digital Diagnostic X-ray System
Indications for Use:
The XGEO GU60A 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
210(k) - K123106
Page 1 of