(25 days)
No
The document describes post-image processing software (SimGrid, BSI, TLE) but does not mention AI, ML, or related terms. The processing described appears to be based on algorithms for contrast compensation, bone suppression, and feature enhancement, which are not inherently AI/ML.
No
This device generates radiographic images for diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states that the systems are "intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician." The "Device Description" further clarifies that the systems are "to be used to take and store image for diagnosis of patients." It also mentions software features that "assist diagnosis" and provide "companion images to assist diagnosis."
No
The device description clearly outlines multiple hardware components (HVG, U-arm positioner, Detector, X-ray tube, etc.) that are integral to the device's function of generating radiographic images. While it includes software features for post-image processing, the core device is a physical X-ray imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for generating radiographic images of human anatomy. This involves imaging the internal structure of the body using X-rays.
- Device Description: The device description details a system for capturing and processing X-ray images of a patient's body. It describes components like an X-ray tube, detector, and software for image processing and storage.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device operates by imaging the patient directly with X-rays, not by analyzing samples taken from the patient. Therefore, it falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand.
These systems are 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.
The GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685).
The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.
The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.
The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image.
These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.
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 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 devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data.
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
January 12, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Samsung Electronics Co., Ltd. % Jaesang Noh Senior Professional, Regulatory Affairs 129 Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA
Re: K173828
Trade/Device Name: GU60A, GU60A-65 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 19, 2017 Received: December 20, 2017
Dear Jaesang Noh:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silv er Spring, MD 20993 w ww.fda.qov
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K173828
Device Name GU60A, GU60A-65
Indications for Use (Describe)
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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) |
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3
510(k) Premarket Notification - Traditional
Image /page/3/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in a bold, sans-serif font. The word is white and is set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.
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 : November 30, 2017
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic B. of Korea
3. Primary Contact Person
- Name: Jaesang NOH & ChulSin Kim A.
- B. Title: Regulatory Affairs Manager
- ပ Phone Number: +82-31-200-1764 & +82-31-200-7661
- D. FAX Number: +82-31-200-6401 E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com_
4. Secondary Contact Person
- A. Name: Ninad Gujar
- B. Title: Director, Regulatory & Quality
- Phone Number: 978-564-8503 ပ
- FAX Number: 978-750-6677 D.
- E-Mail: ngujar@samsungneurologica.com
5. Proposed Devices
- Trade Names: GU60A & GU60A-65 A.
- B. Device Names: GU60A & GU60A-65
- Common Name: Digital Diagnostic X-ray System ﻥ
- Regulation Name: Stationary X-ray system D.
- Requlation: 21 CFR 892.1680 ய்
- ட் Product Code: KPR
Predicate Device 6.
| Predicate Device #1 | Predicate Device #2 | |
|---|---|---|
| Device Name | GU60A & GU60A-65 | GM85 |
| Classification Name | Stationary X-ray System | Mobile X-ray System |
| Product Code | KPR | IZL |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1720 |
| 510(K)# | K151685 | K171119 |
| 510(K) Decision Date | July 17, 2015 | May 12, 2017 |
Device Description 7.
The GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand.
These systems are 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
4
510(k) Premarket Notification - Traditional
Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is set against a blue, oval-shaped background.
used for reading images.
The GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685).
The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.
The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.
The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image.
These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.
8. Intended Use
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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.
Summary of Technological characteristic of the proposed device compared with the 9. predicate device
The proposed device GU60A & GU60A-65 apply a post-image processing software feature as SimGrid, TLE (Tube & Line Enhancement), S-DAP and BSI (Bone Suppression lmage), which was cleared with K171119, to GU60A-65 product which were cleared with K151685 without changes in technical characteristics, materials, energy sources and biocompatibility such as X-ray Tube Assembly and Detectors except of high voltage generator. Optional high voltage generator is added to GU60A model.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicates.
Comparing with Predicate Device #1 and #2 A.
The proposed device is shown as its parts are identical or equivalent with predicate device #1 or #2 while the software features called as SimGrid, BSI, TLE and S-DAP are applied, which does not show significant difference in safety and effectiveness.
| Manufacturer
Contents | Predicate Device
#1 | Proposed Device | Predicate Device
#2 | Discussion |
|--------------------------|------------------------|----------------------|------------------------|------------|
| Device Name | GU60A & GU60A-
65 | GU60A & GU60A-
65 | GM85 | |
| Manufacture | Samsung | Samsung | Samsung | |
| 510(k) Number | K151685 | | K171119 | |
5
Image /page/5/Picture/1 description: The image features the SAMSUNG logo. The word "SAMSUNG" is written in bold, white letters. The wordmark is set against a blue, oval-shaped background.
510(k) Premarket Notification - Traditional
| Appearance | Same as PD#1 | |||
|---|---|---|---|---|
| Image: X-ray machine | Image: X-ray machine | Image: Mobile X-ray machine | ||
| Intended Use | The GU60A & | |||
| GU60A-65 Digital | ||||
| X-ray Imaging | ||||
| Systems are | ||||
| 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. | The GU60A & | |||
| GU60A-65 Digital | ||||
| X-ray Imaging | ||||
| Systems are | ||||
| 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. | The GM85 Digital | |||
| Mobile 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. | Same as PD#1 |
| Manufacturer
Contents | Predicate Device
#1 | Proposed Device | Predicate Device
#2 | Discussion |
|--------------------------|------------------------|---------------------|------------------------|---------------|
| High voltage generator | | | | |
| Model | GU60A | GU60A | - | Same as PD#1 |
| Phase | 3 phase | 3 phase | - | Same as PD#1 |
| Frequency | 50/60 Hz | 50/60 Hz | - | Same as PD#1 |
| Line voltage
±10% | 400/480 VAC | 400/480 VAC
±10% | - | Same as PD#1 |
| Power rating | 50kW | 50kW 68kW | - | Difference(1) |
| kV range | 40 ~ 150 kV | 40 ~ 150 kV | - | Same as PD#1 |
| mA range | 10 ~ 630 mA | 10 ~ 800 mA | - | Difference(2) |
| Time range | 1.0 ms ~ 6.3sec | 1.0 ms ~ 10sec | - | Difference(3) |
| Manufacturer
Contents | Predicate Device
#1 | Proposed Device | Predicate Device
#2 | Discussion |
|--------------------------|------------------------|-----------------|------------------------|--------------|
| Software Feature | | | | |
| BSI | - | BSI | BSI | Same as PD#2 |
| SimGrid | - | SimGrid | SimGrid | Same as PD#2 |
6
Image /page/6/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, rounded, oval shape.
510(k) Premarket Notification - Traditional
| Tube & Line
Enhancement
| (TLE) | - | TLE | TLE | Same as PD#2 |
|---|---|---|---|---|
| S-DAP | - | S-DAP | S-DAP | Same as PD#2 |
| S-Share | S-Share | S-Share | S-Share | Same |
| No | Differences | Explanation |
|---|---|---|
| (1) | Power rating | Optional HVG which is added to the GU60A device has |
| higher max power than the predicate device's max power | ||
| and the higher max power does not contribute any | ||
| adverse impact to the device's safety and effectiveness. | ||
| (2) | mA range | Optional HVG which is added to the GU60A device has |
| higher max current than the predicate device's max | ||
| current and the higher max current does not contribute | ||
| any adverse impact to the device's safety and | ||
| effectiveness. | ||
| (3) | Time range | Optional HVG which is added to the GU60A device has |
| longer max time than the predicate device's max time | ||
| and the longer max time does not contribute any adverse | ||
| impact to the device's safety and effectiveness. |
B. 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.
C. 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 devices show no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
Clinical data D.
The application of SimGrid, TLE, S-DAP and BSI, cleared with K171119, to the proposed device GU60A & GU60A-65 does not require clinical data.
- E. Conclusions
Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices.