(248 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is used for generating radiographic images for diagnosis, not for treating a disease or condition.
Yes
The "Device Description" states that the system is "to be used to take and store image for diagnosis of patients."
No
The device description explicitly lists multiple hardware components (High voltage generator, U-arm positioner, Detector, X-ray tube, Collimator, etc.) and performance studies include electrical, mechanical, and environmental safety testing, indicating it is a hardware-based system with integrated software.
Based on the provided information, the XGEO GU60 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 for diagnosis. This involves imaging the body directly, not testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The components listed (High voltage generator, U-arm positioner, Detector, X-ray tube, Collimator) are all typical components of an X-ray imaging system used for in-vivo imaging.
- Input Imaging Modality: X-ray is an in-vivo imaging modality, not an in-vitro diagnostic method.
- Anatomical Site: The device is used on human anatomy, which is consistent with in-vivo imaging.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The XGEO GU60 operates by passing X-rays through the body to create an image, which is a fundamentally different process from in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The XGEO GU60 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 GU60 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Solidstate X-ray Imaging System Guidance. All test results were satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
510(k) Summary
Image /page/0/Picture/3 description: The image shows a logo and some handwritten text. The logo is for SAMSUNG. The handwritten text says "K123105 Page 1 of 4".
JUN 0 7 2013
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: Sep. 20, 2012
-
- Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
3. Primary Contact Person
- Name: Charlie Mack A.
- B. Title: President of International Regulatory Consultants
- C. Phone Number: 541-376-5063
- FAX Number: 541-376-5063 D.
- E-Mail: charliemack@irc-us.com ய்
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.
- ட. E-Mail: kyungam.shim@samsung.com
5. Device
- Trade Name: XGEO GU60 A.
- B. Common Name: Digital Diagnostic X-ray System
- C. Classification Name: System, X-ray, Stationary
- D. Product Code: KPR
6. Predicate Device
- Manufacturer: DRGEM Corporation A.
- B. Trade Name: Diamond-5A
- C. 510(k) Number: K102408
2 / 5
1
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/1/Picture/1 description: The image shows the Samsung logo. The logo is in black and white, with the word "SAMSUNG" in white letters on a black oval. The logo is simple and recognizable. The font is sans-serif and bold.
510(k) Premarket Notification - Traditional
- D. 510(k) Decision Date: 2010 Dec 27
- র্ব Manufacturer: General Electric Company
- B. Trade Name: Revolution XR/d Digital Radiographic Imaging System
- C. 510(k) Number: K012389
- D. 510(k) Decision Date: 2001 Aug 10
7. Device Description
The XGEO GU60 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.
8. Intended Use
The XGEO GU60 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.
Comparison with predicate device : 9.
Samsung Electronics Co., Ltd., believes that the XGEO GU60 is substantially equivalent to the Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp.
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:
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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.
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Detector type : Phosphor of detector is different. Two major scintillation materials such as Gd2O2S and Csl are commonly used. It affects the image quality but it has not effect on safety.
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Number of pixels : Number of pixels is different. A detector with a large number of
2
SAMSUNG ELECTRONICS Co., Ltd.
Image /page/2/Picture/1 description: The image shows the Samsung logo. The logo is in black and white, with the word "SAMSUNG" in bold, sans-serif letters. The word is enclosed in an oval shape. The logo is slightly distressed, with some small imperfections and noise visible.
510(k) Premarket Notification - Traditional
pixels can cover a wider area of body. It has not effect on safety. (Difference from Revolution XR/d Digital Radiographic Imaging System of General Electric Company, but Similarities to DIAMOND-5A of DRGEM Corporation)
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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 not effect on safety.
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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 not 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 not 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 not effect on safety.
However, these differences do not have an effect on safety and efficiency compared with the predicate device, Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp ..
In summary, the XGEO GU60 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 GU60 is substantially equivalent to Revolution XR/d of General Electric Company and Diamond-5A of DRGEM Corp ..
10. 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 Solidstate X-ray Imaging System Guidance. All test results were satisfied.
11. Conclusions :
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 GU60 is safe and effective and substantially
4 / 5
3
Image /page/3/Picture/0 description: The image shows the Samsung logo on the left side. To the right of the logo, there is handwritten text that says "K123105 Page 4 of 4.". The text appears to be part of a document or report.
:
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional equivalent to predicate devices as described herein.
.
-
- Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
:
- Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
ર / ટ
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is composed of three angled lines that converge to form the shape of a person, with the wordmark surrounding the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
SAMSUNG ELECTRONICS Co., Ltd. % Mr. Charlie Mack Principal Engineer International Regulatory Consultants 77325 Joyce Way ECHO OR 97826
Re: K123105
Trade/Device Name: XGEO GU60 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, Ilisting 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.
5
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/ResourcesforYou/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/Safetv/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/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Smh.P)
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): K123105
Device Name: XGEO GU60
Indications for Use:
The XGEO GU60 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 X (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)
Sm.h.7)
(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health
K123105 510(k)
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